CA2135047C - Ultrasound catheter for removing obstructions from tubular anatomical structures such as blood vessels - Google Patents

Ultrasound catheter for removing obstructions from tubular anatomical structures such as blood vessels Download PDF

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Publication number
CA2135047C
CA2135047C CA002135047A CA2135047A CA2135047C CA 2135047 C CA2135047 C CA 2135047C CA 002135047 A CA002135047 A CA 002135047A CA 2135047 A CA2135047 A CA 2135047A CA 2135047 C CA2135047 C CA 2135047C
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CA
Canada
Prior art keywords
proximal
ultrasound transmission
transmission member
ultrasound
catheter
Prior art date
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Expired - Fee Related
Application number
CA002135047A
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French (fr)
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CA2135047A1 (en
Inventor
Henry Nita
Douglas H. Gesswein
James D. Passafaro
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Abbott Cardiovascular Systems Inc
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Advanced Cardiovascular Systems Inc
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Publication date
Priority claimed from US07/878,795 external-priority patent/US5267954A/en
Application filed by Advanced Cardiovascular Systems Inc filed Critical Advanced Cardiovascular Systems Inc
Publication of CA2135047A1 publication Critical patent/CA2135047A1/en
Application granted granted Critical
Publication of CA2135047C publication Critical patent/CA2135047C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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 the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A61B2017/00101—Temperature using an array of thermosensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/0084—Material properties low friction
    • A61B2017/00849—Material properties low friction with respect to tissue, e.g. hollow organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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 the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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
    • A61B2017/22014—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A61B2017/22015—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member
    • A61B2017/22018—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member segmented along its length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22039—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire eccentric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22041—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire outside the catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A61B2017/320073—Working tips with special features, e.g. extending parts probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320088—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2210/0023—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
    • A61F2210/0042—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply using a fluid, e.g. circulating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
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    • A61M3/0279—Cannula; Nozzles; Tips; their connection means

Abstract

An ultrasound catheter (10) for removing obstructions from tubular anatomic structures such as blood vessels, said catheter comprising an elongate flexible catheter body (20) having an ultrasound transmission member or wire (24) extending longitudi-nally therethrough. A distal head (26) is formed on the distal end of the ultrasound transmission member or wire (24) and is af-fixed to the catheter body (20). The ultrasound transmission member or wire may be formed of any material capable of transmit-ting ultrasonic energy including various superelastic metal alloys such as nickel titanium metal alloys. The distal portion of the ultrasound transmission member or wire (24) may be of reduced diameter to provide enhanced flexibility and/or amplification of the ultrasonic energy through the distal portion of the ultrasound transmission member or wire. A proximal end connector (12) may be provided with a sonic connector to effectively couple the catheter (10) to the ultrasound transducer (14).

Description

ULTRASOUND CATHETER FOR REMOVING OBSTRUCTIONS FROM
TUBULAR ANATOMICAL STRUCTURES SUCH AS BLOOD VESSELS
Field of the Invention The present invention pertains to medical equipment and more particularly an ultrasonic catheter for ablating obstructions within tubular anatomical structures such as blood vessels.
Background of the Invention A number of ultrasonic devices have heretofore been proposed for use in ablating or removing obstructive material from blood vessels. Examples of ultrasonic ablation devices in related apparatus purported to be useable in removing obstructions from blood vessels include those described in United States Patent Nos. 3,433,226 (Boyd), 3,823,717 (Pohlman, et al.), 4,808,153 (Parisi), 4,936,281 (Stasz), 3,565,062 (Kuris), 4,924,863 (Sterzer), 4,870,953 (Don Michael, et al.), and 4,920,954 (Alliger, et al.), as well as other patent publications W087-05739 (Cooper), W089-06515 (Bernstein, et al.), W090-0130 (Sonic Needle Corp.), EP316789 (Don Michael, et al.), DE3,821,836 (Schubert) and DE2,438,648 (Pohlman).
Ultrasound transmitting catheters have been utilized to successfully ablate various types of obstructions from blood 2~3~0~~
dV~ 9312~~35 .. .;l ; : . v; . ,.. .. . pC'f».JS93104207 :~ , i ~ (., vessels of humans and animals. Particular success has been observed in ablation of atherosclerotic plaque or thromboembolic obstructions from peripheral blood vessels such as the femoral arteries. Successful applications of ultrasonic energy to smaller blood vessels, such as the coronary arteries, necessitates the use of ultrasound transmitting catheters which are sufficiently small and flexible to permit transluminal advancement of such catheter through the tortuous vasculature of the aortic arch and coronary tree. AccArdir~gly, the safety and efficacy of removing obstructions from coronary arteries by way of ultrasound is largely dependent ,up~n the size and flexibility of the ultrasound transmitting catheters) employed.
Thus,,th~re exists a need in the art for improved ultrasound catheters which are sufficiently flexible to be advanced and a,nserte~d into both small tortuous blood vessels, such as the coronaries arteries.
garY of the I~avention In accordance with the izwention, there is provided an 2:0 ultrasound catheter device comprising an elongate flexible catheter body havihg at least one lumen extending Longitudinally th~rethrough. An elongate'ultraspund transmission member extends through the catheter body and is connected, at its distal end, to a distal head. The entire aiatal head, or a portion thereof, may pxotrude out of and beyond the distal end of the catheter body.
The distal head is secured or offfixed to the catheter body. .

'~~~s iW0 93/21835 ~ ~ ~ ~ ~ ~ ~ P~.'f/US93/042a7 Further in accordance with the invention, there is provided an ultrasound catheter having an elongate ultrasound transmission member extending longitudinally therethrough, said ultrasound transmission member being formed of one or more superelastic materials, such as certain superelastic metal alloys, which exhibit superelastic properties within the range of temperatures undergone by the ultrasound transmission member during operation of the device. Still fur~laer in accordance with the invention, there is provided an ultrasound catheter having an elongate ultrasound ~,0 transmiasion member extea~di~g longitudinally therethrough, said ~lorigate ultrasound transmission member having a proximal portion of a first cross-sectioncl dimension or diameter and a distal portion of a second cross-sectional dimension or diamster less than saacl fi.rs°t cross-sectional dimension or diameter. Such lessening ~.5 ~f the cr~~s-secti~nal dimension or diameter of the distal portion of tine-ultrasound transmission member results in more flexibility and less rigidity of the ultrasound transmission member within such region thereof. Additionally, such lessening of the cross-secti~nal dimension or diameter of the distal portion of the 2~ ultrasound transmission member results in an amplification of ultrasound transmitted through such t~an~mission member.
Still furtlasr in accordance with the a,nvention, there is pgovided an ultrasound transmission catbe~er having an elongate ultrasound transmission member extending therethrough and a g~idewire passage' lumen extending longitudinally through the catheter to p~rmxt the c2~theter to be utilized in accordance with z~~~o4 r WO 93/21 X35 ., ~. ~ , ,, ~ . PC'f/US9310~8ZQ7 over-the-wire (OTW) insertion techniques.
Still further in accordance with the invention, there is provided.an ultrasound transmission catheter having an elongate ultrasound transmitting member extending longitudinally therethrough and a guidewire guide or member extending. laterally outboard of the catheter in at least one position thereon. Such guidewire guide or support member is provided with at least one guidewire passage aperture extending longitudinally therethrough to permit a gu~.dewire to be passed therethrough, thereby permitting the ultrasound catheter to be utilized in accordance with monorail guideva~.re insertion techniques.
Still further in accordance with the invention, there is provided an ultrasound transmission catheter having an elongate ultrasound transmitting member extending longitudinally ~ therethrough and adist~l guidewire lumen extending longitudinally though only a distal portion of the catheter. Such distal guidewire passage lumen comprises an elongate tube or passageway having a distal end and a proximal end. the distal end of the elongate tube or passageway opens through a distil end aperture and ~p the proximal end of the elongate tube ox passageway opens through a guidewire entry/re-entry aperture formed at a point in the sidewall ~f the catheter. l4ccordingly, a gu~dewire may be proximally or distally edvanced through'said distal guidewire lumen 'n the distal portion of the catheter body while a~remaining withl ~5 proximal portion of the guidewire resides outsa:de of and next to the catheter body;

~~.~.t ~V~D 93/21835 ~ ~ ~ ~ ~ ~ PCT/I3S93104~07 , 5ti11 further in accordance with the invention, there are provided proximal end connector assemblies which operate to connect the proximal end of an ultrasound transmission catheter to an ultrasound transducer. The proximal end connector asse~;blies of a the present invention comprise generally tubular members having at least one longitudinal bore through which the ultrasound transmission member of the catheter may extend and at least one connector apparatus for connecting the ultrasound transmission member to an attendant ultrasound transducer. In one embodiment, the sonic connector comprises a compressible gripping ferrule which may be tightened to grip and firmly hold the ultrasound transmission member in place to provide a damping effect to prevent undesirable transverse movement. In a second embodiment, the sonic connector comprises a plurality of compressible plugs which are als~ tightened to grip and (firmly hold the ultrasound transmission m~~b~~ to achieve the reguired damping effect, as well as to secure the ultrasound transmission member to the sonic connector. In a third embodiment, the sonic connector comprises both a plurality of cvmpressa,ble plugs and a gripping ferrule. In other further 2~ embod~~ne~ts, a p~lymeric boating may be applied to the various connections between °the ultrasound transmission member and the sonic conhector, either in conjunctxnn w~ah the grsppix~g ferrule and~or the c~mgressible plugs or independent of the ferrule and ,: ; , pl~gs~ to secure these connections.
The proximal end connector assemblies of 'the present invention may be provided with one or more fluid infusion sidearms for infusing coolant liquid or other fluid through the bore of the proximal connector and through a lumen of the catheter body. Additionally, in some embodiments, a guidewire passage sidearm may be positioned on the proximal connector assembly to permit insertion and/ or extraction of a guidewire through the proximal connector assembly and through the body of the catheter. One or more guidewire diverting members, such as an angled tubular member, may be positioned within the proximal connector assembly to divert a proximally advancing guidewire out of a guidewire sidearm positioned thereon.
Still further in accordance with the invention, there is provided an ultrasound catheter having an elongate ultrasound transmission member extending longitudinally therethrough, said ultrasound transmission member having a friction-reducing coating or outer jacket formed thereon. Such friction reducing coating or outer jacket may comprise a layer of low friction polymeric material such as polytetrafluoroethylene (ptfe) (teflonT"~ Dupont, Inc., Wilmington, Delaware) or polyethylene. Such friction reducing coating or jacket may be disposed over the entire outer surface of the ultrasound transmission member or may be confined to a specific region or regions thereof.
Other aspects of this invention are as follows:
An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising:

6a (i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component;
(iii) a compressible gripping ferrule positionable between said frontal member and said proximal member;
(iv) said gripping ferrule being sized, configured and constructed relative to said frontal member and said proximal member such that said gripping ferrule will become inwardly compressed against said ultrasound transmission member when said frontal member component and said proximal member are connected to one another by rotatable threaded connection.
An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component;
(iii) a plurality of compressible plugs positionable between said frontal member and said proximal member;

6b (iv) said plurality of compressible plugs being sized and configured relative to said frontal member and said proximal member such that said plugs will become inwardly compressed against said ultrasound transmission member when said frontal member component and said proximal member are connected to one another by rotatable threaded connection.
An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component, said proximal member further including a stem provided with a series of threads thereby forming a second threaded region, said stem configured to receive a correspondingly threaded bore of the horn of a separate ultrasound transducer;
(iii) a plurality of compressible plugs positionable between said proximal member and said bore of said transducer horn;
(iv) said plurality of compressible plugs being sized and configured relative to said proximal member and said transducer horn such that said plugs will become inwardly compressed against said ultrasound transmission member when said proximal member and said bore of said transducer horn are connected to one another by rotatable threaded connection.

6c An ultrasound catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component, said proximal member further including a stem provided with a series of threads thereby forming a second threaded region, said stem configured to receive a correspondingly threaded bore of the horn of a separate ultrasound transducer;
(iii) a plurality of compressible plugs positionable between said proximal member and said bore of said transducer horn;
(iv) a compressible gripping ferrule positionable between said frontal member and said proximal member;
(v) said plurality of compressible plugs being sized and configured relative to said proximal member and said transducer horn, and said gripping ferrule being sized, configured and constructed relative to said frontal member and said proximal member, such that said gripping ferrule and said plurality of plugs will become inwardly compressed against said ultrasound transmission member when said frontal member component and said proximal member are connected to one another and when said proximal member and said bore of said transducer horn are connected to one another by rotatable threaded connection.

6d An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component; and (iii) a coating provided on said threaded region of said frontal member and said first threaded region of said proximal member for securing the threaded connection between said frontal member and said proximal member.
Further objects and aspects of the invention will become apparent to those skilled in the art upon reading and understanding the following detailed description and the accompanying drawings.

2135~4'~ v~~rv~ ,.
~~'~~A~,~ 93/21~3W'~C.°T/US93104207 ? , ~rfef Descr$t~tions of the Drawan s . Figure 1 is a perspective view of a first embodiment of an over-.the-wire ultrasound catheter of the present invention.
Figure 2 is partial enlarged perspective view of the distal end of a ffirst embodiment of an over-the-wire ultrasound catheter of the present invention.
'Figure 2a is a partial cut-away perspective view of an ultrasound transmission member positionable in an ultrasound catheter and having a friction reducing coating or jacket disposed thereon.
Figure 3 is a longitudinal sectional view through Lane 3-3 of Figure 2s figure 4 is an enlarged perspective view of the distal'portion of an embodiment of a monorail ultrasound catheter of the present ~,nvent~on a .
Figure 5 is a perspective view of the distal portion of an embodiment of an ultrasound catheter of the present invention having ~ region of enlarged diameter and a partial guidewire lumen running through a distal portion of the catheter b~c~y.
Figure 5a is a perspective view of the distal portion of an embodiment of an ult~asaund catheter ~f the present invention having a partia3 guidewire lumen running~through a distal portion o~ the catheter body.
Figure ~ is a longitudinal sectional view of the embodiment of 5 tie ultrasound catheter shown in Figure 5.
Figure 6a is an exploded view of a distal tip of the ~13~a4:~. .
CVO 93/21835 '~ ~ a ~~'.r. ~.', f , PCT/iJ~93/04207 ;~ .

ultrasound catheter embodiments shown in Figures 5 and 5a.
Figure 6b is an enlarged view of the distal end of the longitudinal sectional view of Figure 6. , Figure 7 is a perspective view of a .proximal end connector end apparatus positionable on the proximal end of an..ultrasound catheter of the present invention f or connecting the catheter to an ultrasound transducer.
Figure 8 is a perspective view of an alternative proximal end connector assembly positionable on the proximal end of an uZ~rasound. catheter having an internal guidewire lumen for attaching the ultrasound catheter to an ultrasound transducer.
Figure 9 is a longitudinal sectional view of the proximal end comnectdr assembly shown in Figure a.
Figure l0 is a perspective view of the guidewire diverter ~:5 apparatus and a fist embodiment ~f a sonic connector positioned within the pxoximal end connector assembly shown in Figures 5 and Figure al is an enlarged perspective view of a second embodiment of a sonic csannector positioned within the proximal end connector assembly of Figure 10.
Figure 1.2 is a cross-sectional view of the sonic cannector of Figure 11 taken along Line 3.2-12 in Fi~a~re ~.1.
Figure 13 is an enlarged perspective view of a third embodiment offa sonic connector positioned within the proximal end a5 connect~r assembly of F~.gure 10.
Figure 14 is a~ enlarged perspective view of a fourth y 213~Q~~
~V~ 93/21835 PCT/US93/042n7 embodiment of a sonic connector positioned within the proximal end connector assembly of Figure 10.
Figure 15 is an enlarged perspective view of a fifth embodiment of a sonic connector positioned wathin the proximal end connector assembly of Figure 10.
Detailed Descr3~uta.~n ~f Preferred odiments The following detailed description in the accompanying drawings are provided for.purposes of illustrating and describing , speci.f is embodiments of the present invention and are not 'intended to limit the scope of the present invention in any way. .
Tl~e ultrasound catheters of the present invention include both "~~TE.'r-the-wlreo° configurations and "monorail" configuration. As used herein, the team "over-the-wire" shall refer to an ultrasound catheter which has a guidewire passage lumen formed within the body ~f the catheter such hat a flexible guidewire may be advanced through the body of the catheter and out of a guidewire passage aperture formed in the distal end of the catheter. As used herein, the ter~tt ''m~norail" shall refer to an ultrasound catheter which has ~0 a c~uide~tire supporting structure at or near the distal tip of the catheter acrd extenda.ng-laterally outboard of the outer surface of the catheter b~dy such that a flexible guadewire may reside next to ithe catheter body with the distal end of such guidewire extending the guid~wire supporting~structure through and/or being held by f.~rmed on or near the distal end of the catheter body.
Figure 1 is a perspective showing of an over-the-wire PG'T/US93/04207 ::
WO 93/Z1~35 ~ ~ ~ ~
ultrasound catheter 10 of the present invention having a proximal end connector assembly 12,~c~~rited on the proximal end thereof. An ultrasound transducer l~ is connected to the proximal end of the proximal connector assembly 12. An ultrasound generator 16 having 5 a foot actuated on/off switch 18 is operatively connected to the ultrasound generator 14 so as to send ultrasonic energy through the ultrasound catheter l0, when desired.
Cane embodiment of an over-the-wire ultrasound catheter 10 of the present invention are shown in Figures 2 and 3. As shown, one 1.0 embodiment of an over-the-wire ultrasound catheter 10 of the present invention comprises a flexible tubular catheter body 20 having a hollow lumen 22 extending longitudinally therethrough.
This over-the-wire catheter b~dy preferably has an outside diameter of 0.5 mm - 5~0 mm. In catheters 10 intended for insertion into tortuous or relatively small anatomical structures (a.g., the cor~nary arteries) it is preferable that the outer diameter of the catheter body 20 be ~.25 mm - 2.5 mm.
One embodiment of a monorail ultrasound catheter 10a of the present invention are shown in Figure ~. As shown, a monorail ultrasound catheter 10a of the present invention comprises a flexible tubular catheter body 20a having a hollow lumen 22a . extenda.ng longitudinally therethrough. As with the over-the-wire catheter 10, it is preferable that the outside diameter of the catheter body 20a of the monorail catheter 10a be 0.5 mm - 5.0 mm.
In me~norail catheters 10a intended for use in tortuous or relatively small anatomical structures (e. g., the coronary -s~'s WO 93/21835 ~ ~ ~ ~ ~ ~ PC'T/US93/Q420?

arteries) it is preferable that the outer diameter of the catheter body be 0.25 mm - 2.0 mm and it is further specifically preferable that the ',ridth of the distal head 26a be, at its widest point, no greater than~3.0 mm such that the entire distal head 26a and the catheter body 20a may be inserted into an anatomical passage~ray of approximately 3.o xnm diameter, (e. g. the coronary artery).
In both the °'over-the-wire" and "monorail" embodiments of the in~rention, an ultrasound transmission member 24 or wave guide extends longitudinally through the lumen 22 of the catheter body 20 to transmit ultrasonic energy from an ultrasound transducer 14 connected to the proximal end of the catheter 10 to the distal end thereof. Preferably a distal head 26 is mounted on the;distal end of the ultrasound transmission member 24, lr~ the embodiments shown, the: digital head 26 comprises generally round, conical, or disc~shaped distal portion 28 and a reduced diameter neck or proximal portion 3C~. The outer diameter OD of the proximal portion 30: of the distal head 26 is approximately the same es or slightly less than the inner diameter TD of the catheter lumen 22 such that the proxima-i portion 30 of 'the distal head 26 may be inserted into the distal ' end of the 7.umen 22, to a point ,where ~lhe distal tip of the catheter body 20 abuts against the proximal aspect of the distal portion 28 of the distal head 26, as shown.
~ The ultrasound tx~ansmissaon member 24 may be formed of any material capable of effectively transmitt~.ng the ultrasonic energy from the ultrasound transducer 14 to the distal end of the catheter body 2~, including but not necessary limited to metal, plastic, i~V~ 93/Z1835 ~ ~ ~ 5 d 4 r~ PCT/~.JS93/0420? ~'"' hard rubber, ceramic and/or composites thereof.
Tn accordance with one aspect of the invention, all or a portson of the ultrasound transmission member ~4 may be formed of one or more materials which exhiki.~t superelasticity. Such should referably exhib~it~" ~superelasticity coa~sistentiy materials) p . within the range of temperatures normally encountered by the ultrasound transmission member 24 during operation of the device ~~ w Specifically, all or part of the ultrasound transmission ZO member 24 may be formed of one ox, more metal alloys known as "shape memory alloys".
examples of super elastic metal alloys which are usable to form the ultrasound transmission member z4 of the present invention are described in detail in United States Patent Nos. 4,665,906 (Jer'viS) ~ 4 , 565, 589 Garrison) ; 4, 505, 767 (QuiZI) i and 4r., 337, ~90 (~Iaxrison' . The di.selosures of iTnited States Patent loos.
4,665,06, 4,565,589] ~4,55,767; and 4,337,090 are expressly incorporated herein by reference insofar as they describe the compas~.ti~ns properties, chemistries and behavior of specifis metal 0 alloys which are superelastac within the temperature range at which the ultrasound transmission member of the present invention operates, any and all 'of which super~lastic anet~l alloys may be usable to form the superelastic ultrasaund transmission member 24 of the present invention:
~5 In particular, one presently preferred superelastic metal alloy of which the ultrasound transmission member 24 may be formed ''~'y W~ 93/2135 ~ ~ ~ ~ ~ ~ ~ PGT/US931~D4207 is a nickel-titanium alloy wire made up of 55.8 weigh~.percent nickel (NiTi containing 55.8% weight % Ni balance Ti). Such material is coan~nercially available as Tinel'" Wire from Raychem Corporation, Menlo Park, California.
In any embodiment of the device, the ultrasound transmission member 24 may be tapered, narrowed or otherwise reduced in cross--sectional dimension within a distal portion of the catheter so as to decrease the r~.gid~ay of the ultrasound transmission member 24 within such distal portion of the device and also to cause i0 amplification of the u~.'~rasound transmitted to the distal head 26.
As shown in Figure C, such tapering or narrowing of the ultrasound transmission member divides the ultrasound transmission member into a pr~xianal portion 24p and a distal portion 24d. An angular tapered or narrowing region X54 embodies the transition zone 1~ between the larger proximal porti~n 24p and the smaller distal portion 24d: Because the distal portion 24d.of the ultrasound transmission member is of smaller cross-sectional diameter and less mass, it is more flexible and less rigid than the proximal portion ~4p- thereaf. SucD~ configuration of the ultrasound member 24 20 enables the relatively large sized proximal portion 24p to transmit ~nor~ ul rasonic energy than if the entire length of the ultrasound trarasmissir~n xnemlaer 24 were to be of the relatively small cross-sectiona~l size of the distal portion 24d thexeo~. Additionally, such decrease 'in the crcass-sectional size of the distal ~iorti~n 24d ~5 of the ultrasound transmission member 24 results in an amplification of the ultrasound transmitted through such distal ~1~~~~~'~ _ i~VO 93/21835 PGT/LIS93/04207 , , . F ~.:,r'~. 14 portion 24d thereof . Thus, by limiting the reduced size portion of the ultrasound transmission member 24 to a discrete region thereof near the,distal tip of the catheter, the proximal portion 24p of the ultrasound transmission member .is rendered capable of transmitting a greater amount of ultrasonic energy to. the distal .
end of the catheter than would otherwise be possible, while the reduced cross-sectional size of the distal portion of the ultrasound transmission member 24 additionally serves to amplify the ultrasound reaching 'the distal head 26 of the device.
In embodiments of the device wherein an enlarged region 152 is fo~med~ on the catheter body 20b, it is desirable that the taper 154 of the ultrasound transmission member 24b be positioned at the distal end of the bulge ~r enlarged region 152 so as to result in that pbrtion of the catheter lying distal to the distal end of the enlarged region 152 being amore flexible and less rigid than the remainder of said catheter, due to the decreased diameter of the ultras~und transmission member 24d extending through such portion.
In embodiments ~f the de~aice wherein. the cross-sectional dimension or outer diameter of the catheter body is substantially I 2p constant. (i.e., Fi.gure 5a) the tapered region 154 of the ultrasound transmission member 24 may be formed at any point desired such that portion of the catheter lying distal to the tapered region 154 will, as a result; exha.bit less rigidity and greater flexibility than the remainde~c of the catheter body.
25 The present invention further includes an optional improvement to the ultrasound transmission member 24 of any ultrasound ~13~~4~
~1V6'~ 93/2135 P~'1US93/04207 transmitting catheter, said improvement comprising the disposition of a low friction coating or jacket 25 on the outer surface of all or a portion of the ultrasound transmission member 24. As shown in Figure 2a, the low friction coating or jacket 25 may be disposed on 5 the outer surface of the ultrasound transmission member 24 so as to completely cover th.e ultrasound transmission member 24 along its entire length, or along a discrete region or regions thereof . Such coating or jacket 25 may comprise a layer of low friction polymer material such as p~lytetrafluoroethylene (ptfe~ (teflon'~ Dupont, 1~ Inc., Wilmington, De7.aware? or other plastic materials such as polyethylene. The coating or jacket 25 may be applied as a liquid end subsequently allowed to cure or harden on the surface of the' ultrasound transmission member 24. ~ltexnatively, the coating jackef. 25 may be in the form of an' elongate tube slid~ably 5. di~gosable o~rer the outer surface of the ultrasound transmission member ° 24 . Such coating or jacket 25 serves to prevent or diminish fr~:ctior~ between the outer surface of the ultrasound transmission member 24 arid the adjacent structures of the catheter 10 or proximal end connector assembly l2 through which the ultrasound transmission member 24'extends:
The distal head 26 i.s (firmly bonded, a°~tached, or c~nriected to the catheter body 20 such that the distal head is prevented from undergoing longituda,nal or transverse movea~~nt separate from or ;, relative to t'he cathetex body . Such non-moveable of f fixation of the distal head 26 to: the catheter body prevents longitudinal or transverse movement of the distal head 26 apart from the catheter ~Y~ 93121835 ~ ~ ~ ~ ~ ~ PCf/L1S93/~42a7 ;~a.
'; ; , ~, ,., ' ~; ~i~., . 16 body 20. Additionally, such affixation of the distal head to the catheter body increases the conveyance of ultrasound energy into the distal portion of the catheter body 20, thereby resulting in enhanced cavitation effects created by the distal portion of the catheter body. Such bonding connection or attachment of the distal head 2E to the catheter body 20 may be accomplished by any suitable means. One means of attaching the distal head 2s to the catheter body 20 is through the use of adhesive 32.
In the embodiments shown in Figures 2°4, the adhesive 32 is applied to the proximal portion 30 of the distal head 2~ prior~to insertion thereof into the distal end of the lumen 22 of the catheter body 20. The adhesive 32 may comprise any suitable adhesive, such as cyanoacrylate (eg. Loctite"°, Loctite Corp., Ontario, CANADA. or Dron Alpha', Borden, Inc., Columbus, Ohio] or polyurethane (eg. Dymax~°, Dymax Engineering Adhesive, Torrington, CT.) tn firmly bond and attach the distal head 26 to the catheter body 2Q. The distal head 26 may be formed of any suitable rigid material such as metal or plastic. In devices wherein the distal head is formed of pl~a~tic, the surrounding plastic catheter body 20 may ~e thoroughly welded, heat sealed or solvent welded to the plastic distal head 2~b, in accordance with the types of plastics employed:
In the alternat~.ve to the use of adhesives, various mechanical or frictional connectors, such as screw threads, lugs or other surface modifications formed on theproximal portion 3Q of the distal head 2s, may be utilized to hold the distal head 2~ in a ;~~~~ ~~ 93/21835 ~ ~ ~ J ~ ~ ~ PL'f/US93/04207 1.7 , .fixed position relative to the catheter body 20. In such embodiments, corresponding grooves, detents or surface modifications may also be formed in the surrounding inner wall of the catheter body 20 so as to cooperate with any such threads, lugs or other surface modifications formed on the opposing surface of the distal head 26. such threads, lugs or other surface anodifications will be configured and constructed so as to meclhanically or fractionally hold the distal head 26 in fixed position relative to the catheter body 20.
1~ ~ The distal head 26 is preferably formed of radiodense material so as to be easily discernible by radiographic means. Accordingly, the distal head 26 may preferably be formed of instal or, alternatively, may be formed of plastic, ceramic or rubber materials, optionally having one or more radiadense markers affixed theret~ or formed therein. For example, the distal head 26 may be molded of glastic such as acrylonitrile-butadiene-styrene CABS) and ane or more metallic foil strips or other radio opaque markers may.
be affixed to such plastic d~.stal head 26 in order to impart sufficient radaodensity to permit the distal head 26 to be readily J.ocated by z~adiographic means: Additionally, an embodiments whe~eih the distal head 26 is formed ~f molded plastic or other n~n-metall~:c material, a quantity of radiodense filler such as p~o~tdered bismuth or BaS04 may be disposed within the plastic or i:: , other nonmetallic material of which the distal head 26 is formed so as to impart enhanced radiodensity to the distal head 26.
An optional guidewire passage aperture 40 may extend W~ 9312135 213 J ~ ~ ~ PC°T/US93/04207 ' longitudinally through the distal head 26. Such guidewire passage aperture 40 may be formed through the distal head at a location inboard of the catheter body,,.2:0' , such that a guidewire 42 may be advanced through a lumen='y~~''of the catheter body and through guidewire passage aperture 40. Such embodiments of the ultrasound catheter 30 wherein the guidewire 42 passes through a lumen formed within the catheter body 20 and out of the catheter passage aperture 40 constitute an °°over-the-wire°' embodiment of the invention.
i0 Alternatively, the distal head 26a may be formed such that a portion of the distal head extends laterally outboard of the outer surface of the catheter body 20a and the guidewire passage aperture 40a may be, likewise, positioned outboard o.f the outer surface of the catheter body 2Qa thereby forming a guidewire alongside the catheter body 20a and through the guidewire passage aperture 40a.
Such embodiments of the invention wherein the guidewire 42a is passed autboard of the outer surface of the catheter body 20a and though the catheter pa~s~ge aperture 40a are referred to sometimes i~e~ea.n as "monorai~L°° embodiments.
I~ addition to the over-the-wipe embodiment (Fig. 2) and the °'mc~norail'° emb~dim~nt (dig: 4) the ultrasound catheter of the present invention may also be formed in embodiments which constitute combinations or hybrids ~f such over-the-wire and monorail embodiments, ~s shown in Figures 5, 5a and 6.
f5 Specifically, such embodiments of the invention comprise an ultrasound catheter having a guidewire passage leamen f armed through T~~; i~VV~ 93/2185 ~ ~ ~ ~ ~ ~ ~ P~c°°r~us93~~z~7 a distal portion of the catheter body only, with a guidewire entry/re-entry aperture 160 being formed through a sidewall of the catheter to permit passage of the guidewire 42 from the distal guidewire lumen of the catheter to a position outside the catheter body.
As shown in Figures 5, 5a and 6, the catheter body 20b may be provided with a distal guidewire passage tube 156 positioned within the inner bore or lumen, 22b of the catheter body 20b and extending from a guidewire re-entry' aperture 160 to the guidewire passage aperture 4Ob formed in the distal head 26b of the device. As such, the ~xoximal end of a pre-insemed guidewire may be inserted into tie distal end of the catheter body 20b through guidewire passage ape~tur~ 4Ob and subsequently advanced in a proximal direction through the guidewire lumen 158 to a point where the proximal end of he' guidewire 42 emerges out of guidewire entry/re-entry aperture 160. After emerging from g~idewire entry/re-entry apexture 160, the proximal portion of the guidewire 92 may extend and/or reside adjacent the outer surface of the proximal portion of the catheter body 20b as shown. The catheter body 20b and the 2p gui,dewire 42 may then be distally and/or proximally repositioned, rel~rtive to one another, during the procedure. ~7Lso, if desired, the guic3ewire ~2 may be fully withdrawn and extracted by pulling the guidewire in a proximal direction such that'the distal tip of the guidewirel is pulled out of the guidewire entry/re-entry aperture 160 and the guidewire 42 ~:s subse~ue~tly fully withdrawn out of the body, leaving only the ultrasound catheter in place.

~~ 93/21835 ~ 13 ~ ~ ~ P~'lLJS93144207 '".~, y Another alternative configuration and construction of the distal head 2~ is shown in the embodiments of Figures 5, 5a, 6, 6a and 6b. In such embodiments, the di.s~al head 26b, 26c is secured ,. v to the distal end of the catheter'vbody 20b, 20c by way of an 5 annular ring member 150 and a quantity of adhesive. ASH. As specifically shown in the views of Figure 6, 6a and 5b, this embodiment ~f the distal head 26b comprises a distal portion 28b and a reduced diameter proximal portion 30b which is insertable into the distal end of he lumen 22b of the catheter body 20b. The 10 distal portion 28b of the distal head~26b has a grooved detent or annular shoulder 1..48 formed therein. The proximal portion 30b of the distal head 26b is inserted into the distal end of the lumen 20b of the catheter body and may be secured thereto by way of a quantity of adhesive. An annular ring member 150 is then passed in y5 a ~ro~imal d~:rection ove~° the catheter body 20b and advanced to a point where the annular ring member 150 abuts against shoulder 148.
A quantity of adhesave ADH is then applied to secure the annular ring member 150 around the distal tip of the catheter body 20b and the part ~f the distal portion 28b of the distal head 26b. The ~ adhes~.v~ ADH may b~ tapered or smoothed to form a constant angular transi~ion'from the distal p~r~ion 28b ~f the distal head 2~b to thc' outer surface of tl~e catheter body 2Ob as shown. The distal head ~6b and annular ring meanber 150 may be formed of any suitable rigid material such as metal or plastics In embodiments where metal materials are employed, metal bonding or metal welding may be utilized as an alternative to or in addition to the, use of P(.T/US931~D4207 ''~~ VV~ 93/21 X35 adhesives for bonding the assembly to the distal end of the catheter body 20b. In embodiments wherein the distal head 2fb and annular ring member 150 are formed of plastic, thermal welding, heat fusing or solvent welding techniques may be used as an alternative or in addition to the use of adhesives_ for such purpose.
In the embodiment of the distal head shown in Figures 5~-6, it is preferable that the outer diameter of the annular ring member 150 be approximately the same as the largest outer diameter of the extreme distal portion 28b of the distal head 26b such that a smooth transition is formed from the distal head 26b to tine outer surface of the catheter body ZOb.
optionally; one or more fluid outflow aperture(sj 50 are formed a~ or near the distal end of the catheter body 20 to permit fluid to flow out of a lumen 22 of the catheter 1Ø The provision of such fluid outflow apertures) 50 near the distal end of the catheter 10 facilitates continual or intermittent passage of coolant' liquid into tae proximal entl of the lumen 22 , distally thrs~ugh the lumen 22, end out of fluid outflow apertures) 50.
Pr~~e~~bly, the lumen 22 of the catheter l0 into which the fluid outflo~r aperture (s) comrnun~.c~tes will be the same lumen wherein the ultrasound transmission member 2~ is looted such that coolant lic~uid,~~y be infused into the proximal end o~ such lumen 22, distally therethxdugh and out of fluid outflow aperture('s) 50 in a manner that will baths and cool the body of the ultrasound transmiss~.on member 24, thereby preventing the ultrasound dV~ 9312135 ~ ~ ~ ~ ~ ~ ~ PGTfUS93fm42a? ~'' transmission member 24 from overheating during use.
In addition to, or in the alternative to, the optional fluid outf .low aperture (s) 50 formed in the~~ ;catheter body 20, one or more fluid outf .low apertures) 51 may.~~-,formed through the distal head 26 to permit fluid to flow directly out of the distal.. end of the catheter 1~. In embodiments having a guidewire aperture 4~ formed through the distal heed 26, such guidewire aperture may be slightly larger than the outer diameter of the guidewire 42 to be passed ther~through so as tc~ permit f laid to be infused through the ZO g~x~.dewire lumen a~ad to pass out of the guidewire aperture 40, even when a guidewire 42 is extending therethrough. Thus, the guidewire aperture 40 may, in some embodiments, preclude the necessity for and/or perform the function of a separate dedicated fluid outflow aperture 53 extending thrQUgh the distal head 26:
1~ O~tion~.lly, ~ne or more separate lumens having separate outflow apertures firmed at or near the distal tip of the catheter may be forxiiied- for infusion'of oxygenated perfusate, medicaments or other fl.uis~s into the blood vessel or other anatomical structure in tahich the catheter is posita:oned:
p °~ariotas types and designs of proximal end connector apparatus 12 may be positioned on the proximal end of the catheter body to facilitate operative connection of the ultrasound transmission member 2~ to an ultrasound transducer 14 and ultrasound generation de~tice 16. Examples of embodiments of such proximal end~connector 25 apparatus 12 are shown in Figures 'i-lt?: Figure ? shows a x~e~:atively simple proximal end connector apparatus 12a configured ... . ~_ ~ _ . ~.
. :: . ,. ... ~. ,.. . , ~,a.~~v~ a '~~''4 ~O 9~f21835 PCf/U~1~/04207 for use in connection with catheters which do not incorporate internal guidewire passage lumens. Figure 8 shows a more complex proximal end connector 12b configured for use in connection with catheters having internal guidewire passage lumens.
The embodiment of the proximal end connector 12a shown in Figure 7 comprises a rear portion 92 and a mid-portion 90. A
gripping member 96 formed on the proximal end of the mid-portion 90 operates to attach the proximal end connector 12a to the proximal end of the catheter 20. The mid-portion 90 comprises an elongate tubular body 80 having a tubular fluid infusion sidearm 82 extending outwardly therefrom to permit infusion of coolant fluid or other liquid into the inner lumen 81 of the proximal end connector 12a.
The more complex embodiment ~f the proximal end connector 12b shown in Figure 8 comprises the same rear portion 92 and mid port3oz~ 90 as the simpler embodiment 12a shorn in Figure 7.
H~w~ver, the moxe oompl~x embodiment 12b of Figure 8 further comprises a frontal portion 88 which is configured and constructed ~tt~ facilitate insertion and/ar extraction of a guidewire 42 through 2p' a luanen or passageway fe~rmed internally within the catheter 20.
In both embodiments shown, the proximal end connector apparatus 12 comprises'an elongate rigid body 80 having a hollow .
bore 8.1 extending longitudinally therethrough. 7Ln the embodiment shora~i, the ~l~onga~e body of the proximal end connector 12 is actually constructed of a frontal portion 88, a mid-portion 90 and a rear portion 92. The frontal portion 88 of the elongate body 80 VV~ 93/21835 2 ~' 3 ~ ~ ~ ~ rv°~-ivs~~~oazo~ . _ _ is fi~°~mmly connected ~to the proximal end of the catheter body 20 by ~aay of a threaded gripping member 94. A sleeve 21 havixog an annular flange 23 formed on the proximal end thereof is positioned , on the proximal end of the cater body 20 to engage gripping member 94 as shown. The proximal end of the frontal portion 88 is connected to the distal end of the mid-portion 90 of the elongate body 80 by way of a second gripping member 96. Accordingly, to facilitate such construction, threads 98, 100 are formed on the ~pposite ends of the frontal portion 88 of the elongate body 80.
~.0 Threads 102 are also formed on the proximal end of the mid-por~ion 9~ of the elongate body 80 such that the mid-portion 90 may be threadably mounted within a correspondingly threaded bore formed Zn the distal erad of 'the rear portion 92 of.the elongate body 80.
An 0-ring 104 is positioned at the bottom of the threaded bore formed in the distal end of the rear portion 92 such that, when the rear portion 92 is tightened over the threads 102 of the mid' portion 90, the px~ximal end 108 of the mi~3-portion 90 will abut against and compress ~-ring 104 against ledge 105, thereby causing Q°~ring . 104 to exert i.ntaard pressure against tube .110. Tube 110 p extends longitudinally through the hollow bore 81 within the rear po~rtio~ 92 of the proximal connector apparatus 12. The ultrasound transmission member 24 or wave guide extends hngitudinally through the entire catheter body 20 and through the pr~ximal end connector 12. The ul~ras~ound transmission member 24 or wave guide is Z5 inserted into and engaged- by threaded proximal donr~ector 112. ' Threaded proximal conn;~ector 112 is positioned within a cylindrical. .

'~~~~= dV~ ~3f2~835 213 ~ 0 4 7 p~/US93/0420°~
recess l14 formed in the proximal end of the proximal connector apparatus 12. A suitable ultrasound transducer 14 may be screwed onto and threadably connected to the threaded proximal connector 132 to accomplish passage of ultrasonic energy through the 5 ultrasound transmission member 24 in a distal direction to the distal head 25 of the device.
The extxeme proximal ez~d of the proximal connector 12 ~is pr~vided with a sonic connector assembly or apparatus conf figured to effect operative attachment of the proximal end of the ultrasound 10 transmission member 24 to the horn of an ultrasound transducer 14.
The sonic connector assembly ar apparatus is preferably configured and constructed to permit passage of ultrasound energy through the ultrasound transmission member or wave guide 24 with minimal lateral side-to-side movement of the ultrasound transmission member 24 while, at the same time, permitting unrestricted longitudinal forward/backward vibration or movement of the ultrasound transmission member 24:
In one embodiment of the sonic connector shown in Figure 10, a dzstal p~rtion of the body ~f the threaded proximal connector 112 2~ is configured to receive therein a compressible gripping ferrule 3:16. Compressible gripping ferrule 116 has a small central apert~tr~ formed ther~through through which the ultrasound transmission member 24 passes, as shown. A frontal member 118 is ~th=e~tiably tightened within the frontal portion of the body of 25 proximal connector member 112 so as to compress gripping ferrule 116, thereby causing gripping ferrule 116 to firmly grip and hold WO 93/2135 ~ 13 ~ ~ 4 l P~_'T/U~93/04207 the ultrasound transmission member 24~in~place within the body of the proximal connector member~:.112.~ The proximal connector member 112 ray then be compressed or crimped inwardly so as to be additionally crimp connected or crimp fit to the proximal end of a the ultrasound transmission member 24, thereby providing further gripping and attachment of the sonic connector assembly to the proximal end of the ultrasound transmission member. A series of threads are formed on the outer surface of the proximal connector member 112 to permit the .distal end of an ultrasound transducer horn to be threadably screwed onto and releasably attached to the sonic connector assembly. Thus, the frontal member 118, gripping ferrule 116, and proximal connector member 112 combine to form a s~hic connectar assembly td which the horn of an ultrasound transducer may be attached and through which the ultrasonic energy may be transmitted into the ultrasound transmissipn member, with the gripping ferrule 116 acting to dampen transverse movement of the u~.trasound transmissionnnember 24.
In ~ second embodiment of the sonic connector, which is shown in Figures ll and 12, a frontal member 218 is positionable on the 2~ ultrasound transmissiora:m~~nber 24, and has a stem 220 with threads 222 pr~vi.ded thereon fot threadable engagement with threads 221 prow~ded in an opening of a proximal connector 212. A plurality of ' compressible plugs 224 are configured to fit within the opening of the pr~ximal 'connector 212 perpendicular to the axis of the ultrasound transmission member 24. Tn the preferred embodiment, four compressible plugs 224 are provided, but it will be "~~ ~V(~ 93/Z1~35 '~ 1'~ ~ ~ ~ ~ F~l('/LJ593f0420~

appreciated by those skilled 'in the art that any number of compressible plugs 224 may be distributed about the circumference of the ultrasound transmission member 24. The proximal connector 212 is also positionable on the ultrasound transmission member 24 and also has a stem 214 with threads 216 provided~thereon for threadable engagement with threads 217 provided on a cavity 226 of a horn 228 of the ultrasound transducer 14. l~gain, a plurality of compressible plugs 224 are configured to fit within the cavity 226 of the ultrasound transducer horn 228 perpendicular to the axis of 1(D~ the ultrasound transmission member 24. The proximal~most end of the ultrasound transmission member 24 terminates at the promixal-most end of the stem 214 within the cavity 226. The stem 214 and the ultrasound transmission member 24 may be crimped as shown at °230 to provide a more stable connection between the sonic connector 1~ assely and the ultrasound transmission member 24. The frontal member 218 and the proximal connector 212 are preferably made from stainless steel.
The compressible plugs 224 are preferably disposed along the threads 216., 217, 221 and 222 so that when the frontal member 218 .2~ is threadably screwed onto the proximal connector 212 and the proximal connector 21.2 is in turn threa~a~aly screwed onto the ultrasound transducer h~rn 228, the threads 216, 217, 221 and 222 exert an inward force against the plugs 224 provided thereat, thereby forcing the plugs 224 against the ultrasound transmission 2 5 member 24 to provide a firm grip to minimize transverse movement of the ultrasound transmission member 2~4. The compressible plugs 224 213~~47 VVO 93/2135 FCT/US931042~17 .'""
a;. ..

are preferably made from any compliant material such as plastic, nylon, teflon, .ABS, polypropylene, polyolefins, natural and synthetic rubbers and et~ayl'.ene vinyl acetate (F:V~) . The compliance , of the plugs 224 also secures the threaded connection between the frontal member 218 and the proximal connector 212 so..that this connection does not become loosened, which would otherwise cause the ultrasound transmission member 24 to become disengaged. It wall be appreciated by those skilled in the art that the plugs 224 may be provided at the threads 221 and 222 only, or at the threads lp 21f and 217 only, at both sits of threads 216 and 217 and 221 and 222, or elsewhere along the stems 214 and 220.
lh a third embodiment of the sonic connector, which is shown in Figure 13, a gripping ferrule 116 is positioned between the threaded connection between the frontal member 218 and the pro~cimal 'connector 212. A plurality of compressible plugs 224 are positioned between the threaded connect~:on between the proximal connector 212 and the transducer horn 228. Thus, the embodiment of Fagure l3 utilizes both the gripping ferrule and the compressible plugs tc achieve the damping of transverse Movement by the ult~asoux~d transmission member 24, and ~~ secure the ultrasound transmissi~n member ~4 to the sonic connect~r.
~11°tern~tively, a polymeric coating may be applied to the threads 216, 2~.7, 221 arid 222: The coating creates friction which functions 'tosecure the threaded conn~cti~ns and prevent the threaded connections from becoming loose: Thia polymeric coating may' be made by pVC dispersions using a solvent release approach, or 213 5 4 4 7 PCTfUS93/04207 ~~ ~ W~ 93/21835 by thermal application of various thermoplastics such as polyethelene, EV.A, and nylon, among others. It will be appreciated by those skilled in the art that the polymeric coating may be applied independent of the compressible plugs 224, or in conjunction with the compressible plugs 224. The polymeric coating . may also be applied to the threaded regions of the first embodiment of the sonic connector assembly described in connection with Figure 10. Alternatively, the polymeric coating may also be applied betraeen the threaded connection between the proximal connector 212 ~,0 ahd the transducer horn 22$, with compressible plugs 224 or a gripping ferrule 116 provided between the threaded connection between the frontal member 218 and the proximal connector 212. For example, the embodiment of Figure 14 has a.polymeric coating 250 provided between the transducer horn 228 and the proximal connector 212, with compressible plugs 224 provided i~etween the frontal ~aembe~ 218 and the prox~.n~al connect~r 212. Similarly, the emb~dimen~ ~f Figure 15 has a polymeric coating 250 provided between' the transducer horn 228 and the proximal connector 212, with a gripping ferrule 116 provided between the frontal member 218 2~ and the prcaximal connector 212.
The elongate tube 110 which extends through the rear portion 92 pf the proximal doz~nector apparatus 12 is specifically sued ucY~ that the lumen 120 ~f the tube 1~.0 is large enough to permit the ul~rasoua~d transmission member 142 to pass therethrdugh with a small amount of space remaining between tie outer surface of the ultrasound transmission member 24 and the ixzner luminal surface of ,r , ::
~:,..~ , . . .. .

i~Y~ 93!21835 ~ ~ ~ ~ ~ ~ ~ PCTlUS93l04207 ;.--. 1 the tube 1.10.
.~ fluid inlet sidearm 82 is formed on the rigid body 80 of the proximal end connector apparatus 12. Such fluid inlet sidearm 82 has a hollow bore 122 which extends therethrough and is in fluid 5 communication with the longitudinal'~,rbbre 81 of . the proximal end '~ .
connector 12.
Thus, pressurised fluid, such as a coolant liquid, may be infused through sidearm 82, through bore 81 and through the lumen 22 of the catheter body 20 to a point where such liquid f lows out ~:0 ~f flu~.d outflow apertures 50. The temperature and flow rate of such coo~,ant liquid may be specifically controlled to maintain the temperature of the ultrasound transmission member 24 at a desired temperature within'its optimal warking range. In particular, in embodiments of the invention wherein the ultrasound transmission 15 member 24, is formed ~f a metal alloy which exhibits optimal physicaz prc~pexties (e.g. super elasticity) within a specific range of temperatures, the temperature and flow rate of coolant liquid infused trough fluid infusion sidearm 82 may be specifically controlled to maintain the temperature of the ultrasound 20 tran,emissioh member within the range of temperatures at which it demonstrates its moet desirable phys.ica~. pr~perties. For example, in embodimez~~s of the invention wherein the ultrasound transmission member 24 is f~rmed of a shape memory allay 'which exhibits super ,:~ ~ ''' ~ ' elasticity when in its mart~nsite state, but'which loses super z5 elasticity as it transitions to an austenite state, it will be desirable to adjust the temperature and f low rate of the coolant 2~~~047 ~'~' !f~ X3/21835 ~ PL'T/iJS93/44247 liquid infused through fluid infusion sidearm 82 so as to maintain the shape memory alloy of the ultrasound transmission member 24 within a temperature range at which the alloy will remain in its martensite state and will not transition to an austenite state.
The temperature at which such shape memory alloys transition from a martensite state to ~an austenite state is known as the "martensite transition temperature" (MS) of the material. Thus, in these embodiments, the fluid infused through sidearm 82 will be at such temperature, end will be infused at such rate, as to maintain 3;p the shape memory alloy of the ultrasound transmission member 24 below its martensite transition temperature (MS).
A guidewire insertion sidearm $4 may also be formed on the elongate body 80 of the proximal end connector apparatus 12. Such guidewire passage sidearm 84 has a hollow lumen 130 extending ~,he~athrough and communicating with the ~e~ngitudinal bore 81 of the proximal end connector 12. 1~ guidewire gripp3ng~/sealing apparatus 13~ may be mounted ~n guidewire passage sidearm 84 to grasp and hold the guidewire '42 in fixed longitudinal position relative to the catheter l0 and to provide a seal to prevent backflow of blood ~hro~agh he catheter 10. Examples of gui~3ewire grippingJsealing apparatus 13.2 which mad be utilized in thin application include those which are wMch are available commercially as Product Nos.
190501'7A and 190501.4A from Medical Disposables International, West Conshocken, ~~PI~. Such commercially available ~guidewire gripping/valving apparatus 232 may be modified by inserting a segment of plastic tubing 134 into the bore of such device to fV'V~ 93/21835 ~ ~ 3 5 ~ '~ r( PCT/~JS93/04207 permit such device 132 to grip and seal against a guidewa:re 42 which is smaller in diameter than the existing diameter of the seal provided in such commercially available l~DZ sealing/valving apparatus 132. Other sealing/valving ;apparatus may also be .~
employed. "~;;; . .
.:.,\
Additionally, in the embodimerat:w'shown in E'igure 9, an angled guidewire diverter tube 140 is positioned within the bore 13~ of the guidewire passage sidearm 84 and a portion of the longitudinal bore 81 of the body 8~ of the proximal end connector apparatus 12.
Such guidewire diverter tube 140 comprises an obtuse angular bend B having an aperture 142 formed at the outer apex of such angular bend 8, The aperture 142 is sufficiently large to permit the ultrasound transmission member 24 to. pass longitudinally therethrough without damping or interference from the body of the 3:5 tube 1~~. Also, the aperture 142 is sufficiently large to allow irrigation/coolant liquid to flow therethrough when the ultrasound t~ansmis~ion member 24 is positioned within the aperture 1.42.
The guidewire diverter tube 144 is configured and constructed such that, as the proximal end of guidewire 42 is advanced in a as proximal dirQCtion through the longitudinal bore 81 of the elongate body 80 of the pro~3mal end connector l2, it will -impinge against the wall o~ gui,dewire dive~ter tube 140 and wall thus be diverted outwardly through the guidewire passage sidearm 84.
Although th;e invention has been described herein with specific 2a re~er~:nce °to presently preferred embodiments thereof, it will be appreciated by those skilled in the art that various additions, ~'°~'~ i~~ 9~/21~35 r~ PCT/IJS93/04207 modifications, deletions and alterations may be made to such preferred emlaodiments without departing from the spirit and scope of the invention. Accordingly, it is intended that all reasonably foreseeable additions, deletions, alterations and modifications be included within the scope of the invention as defined in the following claims.

Claims (29)

WHAT IS CLAIMED IS:
1. An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising:
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component;

(iii) a compressible gripping ferrule positionable between said frontal member and said proximal member;
(iv) said gripping ferrule being sized, configured and constructed relative to said frontal member and said proximal member such that said gripping ferrule will become inwardly compressed against said ultrasound transmission member when said frontal member component and said proximal member are connected to one another by rotatable threaded connection.
2. The ultrasonic catheter of claim 1 wherein a series of threads are formed on said proximal member thereby forming a second threaded region, said second threaded region adapted to receive a correspondingly threaded bore of the horn of a separate ultrasound transducer, thereby establishing a releasable screw connection between said ultrasonic catheter and said separate transducer horn.
3. The ultrasonic catheter of claim 2 wherein said sonic connector assembly is positioned on the extreme proximal end of said ultrasound transmission member with the proximal end of said ultrasound transmission member being coterminous with the proximal-most extent of said proximal member of said sonic connector assembly.
4. The ultrasonic catheter of claim 1 wherein said proximal member is further affixed to said ultrasound transmission member to accomplish additional crimp connection of said sonic connector assembly to said ultrasound transmission member.
5. The ultrasonic catheter of claim 1 wherein said threaded region of said frontal member and said first threaded region of said proximal member are coated with a polymeric coating.
6. The ultrasonic catheter of claim 1 wherein said second threaded region of said proximal member is coated with a polymeric coating.
7. An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component;
(iii) a plurality of compressible plugs positionable between said frontal member and said proximal member;
(iv) said plurality of compressible plugs being sized and configured relative to said frontal member and said proximal member such that said plugs will become inwardly compressed against said ultrasound transmission member when said frontal member component and said proximal member are connected to one another by rotatable threaded connection.
8. The ultrasonic catheter of claim 7 wherein a series of threads are formed on a stem of said proximal member thereby forming a second threaded region, said stem configured to receive a correspondingly threaded bore of the horn of a separate ultrasound transducer, thereby establishing a releasable screw connection between said ultrasonic catheter and said separate transducer horn.
9. The ultrasonic catheter of claim 8 wherein said sonic connector assembly is positioned on the extreme proximal end of said ultrasound transmission member with the proximal end of said ultrasound transmission member being coterminous with the proximal-most extent of said proximal member of said sonic connector assembly.
10. The ultrasonic catheter of claim 7 wherein said proximal member is further affixed to said ultrasound transmission member to accomplish additional crimp connection of said sonic connector assembly to said ultrasound transmission member.
11. The ultrasonic catheter of claim 8 wherein said plurality of plugs are positioned on said threaded region of said frontal member.
12. The ultrasonic catheter of claim 11 wherein said second threaded region of said proximal member and said threaded bore of said transducer horn are coated with a polymeric coating.
13. The ultrasonic catheter of claim 8 wherein said plurality of plugs are positioned on said second threaded region of said proximal member.
14. The ultrasonic catheter of claim 8 wherein said plurality of plugs are positioned on said threaded region of said frontal member and on said second threaded region of said proximal member.
15. The ultrasonic catheter of claim 14 wherein said threaded region of said frontal member, said first threaded region of said proximal member, said second threaded region of said proximal member, and said threaded bore of said transducer horn are coated with a polymeric coating.
16. An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component. said proximal member further including a stem provided with a series of threads thereby forming a second threaded region, said stem configured to receive a correspondingly threaded bore of the horn of a separate ultrasound transducer;
(iii) a plurality of compressible plugs positionable between said proximal member and said bore of said transducer horn;
(iv) said plurality of compressible plugs being sized and configured relative to said proximal member and said transducer horn such that said plugs will become inwardly compressed against said ultrasound transmission member when said proximal member and said bore of said transducer horn are connected to one another by rotatable threaded connection.
17. The ultrasonic catheter of claim 16 wherein said sonic connector assembly is positioned on the extreme proximal end of said ultrasound transmission member with the proximal end of said ultrasound transmission member being coterminous with the proximal-most extent of said proximal member of said sonic connector assembly.
18. The ultrasonic catheter of claim 16 wherein said proximal member is further affixed to said ultrasound transmission member to accomplish additional crimp connection of said sonic connector assembly to said ultrasound transmission member.
19. The ultrasonic catheter of claim 16 wherein said plurality of plugs are positioned on said second threaded region of said proximal member.
20. The ultrasonic catheter of claim 16 wherein said threaded region of said frontal member and said first threaded region of said proximal member are coated with a polymeric coating.
21. The ultrasonic catheter of claim 16 wherein said threaded region of said frontal member, said first threaded region of said proximal member, said second threaded region of said proximal member, and said threaded bore of said transducer horn are coated with a polymeric coating.
22. An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component. said proximal member further including a stem provided with a series of threads thereby forming a second threaded region, said stem configured to receive a correspondingly threaded bore of the horn of a separate ultrasound transducer;
(iii) a plurality of compressible plugs positionable between said proximal member and said bore of said transducer horn;
(iv) a compressible gripping ferrule positionable between said frontal member and said proximal member;
(v) said plurality of compressible plugs being sized and configured relative to said proximal member and said transducer horn, and said gripping ferrule being sized, configured and constructed relative to said frontal member and said proximal member, such that said gripping ferrule and said plurality of plugs will become inwardly compressed against said ultrasound transmission member when said frontal member component and said proximal member are connected to one another and when said proximal member and said bore of said transducer horn are connected to one another by rotatable threaded connection.
23. The ultrasonic catheter of claim 22 wherein said sonic connector assembly is positioned on the extreme proximal end of said ultrasound transmission member with the proximal end of said ultrasound transmission member being coterminous with the proximal-most extent of said proximal member of said sonic connector assembly.
24. The ultrasonic catheter of claim 22 wherein said proximal member is further affixed to said ultrasound transmission member to accomplish additional crimp connection of said sonic connector assembly to said ultrasound transmission member.
25. The ultrasonic catheter of claim 22 wherein said plurality of plugs are positioned on sari second threaded region of said proximal member.
26. The ultrasonic catheter of claim 22 wherein said threaded region of said frontal member, said first threaded region of said proximal member, said second threaded region of said proximal member, and said threaded bore of said transducer horn are coated with a polymeric coating.
27. An ultrasonic catheter for removing obstructions from tubular anatomical structures such as blood vessels, said ultrasonic catheter comprising:
an elongated flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;
an ultrasound transmission member extending longitudinally through said lumen of said catheter, said ultrasound transmission member having a proximal end connectable to a separate ultrasound generating device and a distal end terminating adjacent the distal end of said catheter body;
a sonic connector assembly being positioned on the proximal end of said ultrasound transmission member to facilitate connection of said ultrasound transmission member to a separate ultrasound transducer, said sonic connector assembly comprising;
(i) a frontal member positionable on said ultrasound transmission member and having a threaded region formed thereon;
(ii) a proximal member positionable on said ultrasound transmission member and having a first threaded region formed thereon and rotatably engageable with the threaded region of said frontal member component; and (iii) a coating provided on said threaded region of said frontal member and said first threaded region of said proximal member for securing the threaded connection between said frontal member and said proximal member.
28. The ultrasonic catheter of claim 27 wherein a series of threads are formed on a stem of said proximal member thereby forming a second threaded region, said stem configured to receive a correspondingly threaded bore of the horn of a separate ultrasound transducer, thereby establishing a releasable screw connection between said ultrasonic catheter and said separate transducer horn.
29. The ultrasonic catheter of claim 28 wherein said second threaded region of said proximal member and said threaded bore of said transducer horn are coated with a polymeric coating.
CA002135047A 1992-05-05 1993-05-04 Ultrasound catheter for removing obstructions from tubular anatomical structures such as blood vessels Expired - Fee Related CA2135047C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US07/878,795 US5267954A (en) 1991-01-11 1992-05-05 Ultra-sound catheter for removing obstructions from tubular anatomical structures such as blood vessels
US07/878,795 1992-05-05
US07/911,546 US5312328A (en) 1991-01-11 1992-07-09 Ultra-sound catheter for removing obstructions from tubular anatomical structures such as blood vessels
US07/911,546 1992-07-09
PCT/US1993/004207 WO1993021835A1 (en) 1992-05-05 1993-05-04 Ultrasound catheter for removing obstructions from tubular anatomical structures such as blood vessels

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CA2135047A1 CA2135047A1 (en) 1993-11-11
CA2135047C true CA2135047C (en) 2001-10-02

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US (1) US5312328A (en)
EP (1) EP0639953B1 (en)
JP (1) JP3398871B2 (en)
CA (1) CA2135047C (en)
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WO (1) WO1993021835A1 (en)

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