US20180140321A1 - Catheter With Retractable Sheath And Methods Thereof - Google Patents

Catheter With Retractable Sheath And Methods Thereof Download PDF

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Publication number
US20180140321A1
US20180140321A1 US15/360,834 US201615360834A US2018140321A1 US 20180140321 A1 US20180140321 A1 US 20180140321A1 US 201615360834 A US201615360834 A US 201615360834A US 2018140321 A1 US2018140321 A1 US 2018140321A1
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United States
Prior art keywords
sheath
core wire
retraction
ultrasound
length
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
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US15/360,834
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English (en)
Inventor
Deepa Deepa
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CR Bard Inc
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CR Bard Inc
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Publication date
Application filed by CR Bard Inc filed Critical CR Bard Inc
Priority to US15/360,834 priority Critical patent/US20180140321A1/en
Priority to CN201780072386.9A priority patent/CN110022778B/zh
Priority to PCT/US2017/030675 priority patent/WO2018097856A1/en
Priority to JP2019547570A priority patent/JP7278954B2/ja
Priority to EP17874057.7A priority patent/EP3544520B1/en
Priority to US16/348,923 priority patent/US11712259B2/en
Priority to PCT/US2017/060195 priority patent/WO2018097953A2/en
Priority to US16/462,260 priority patent/US11633206B2/en
Assigned to C. R. BARD, INC. reassignment C. R. BARD, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DEEPA, DEEPA
Publication of US20180140321A1 publication Critical patent/US20180140321A1/en
Priority to JP2022036853A priority patent/JP7303341B2/ja
Priority to US18/331,390 priority patent/US20230397923A1/en
Abandoned legal-status Critical Current

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    • 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
    • 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
    • A61B2017/00973—Surgical instruments, devices or methods, e.g. tourniquets pedal-operated
    • 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
    • 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
    • A61B2017/22072—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 an instrument channel, e.g. for replacing one instrument by the other
    • A61B2017/22074—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 an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
    • A61B2017/22075—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 an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel with motorized advancing or retracting means
    • 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
    • A61B2017/320069—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for ablating tissue
    • 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
    • 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
    • A61B2017/320084—Irrigation sleeves
    • 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
    • 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means

Definitions

  • This application generally relates to catheters with retractable sheaths.
  • the catheters are for modification of one or more intravascular lesions associated with atherosclerosis.
  • Atherosclerosis is characterized by one or more intravascular lesions formed in part of plaque including blood-borne substances such as fat, cholesterol, and calcium.
  • An intravascular lesion such as an arterial lesion can form on a wall of an arterial lumen and build out across the lumen to an opposite wall thereof. A last point of patency often occurs at a boundary between the arterial lesion and the opposite wall of the arterial lumen.
  • Surgical procedures for atherosclerosis such as angioplasty or atherectomy can be used to restore patency and blood flow lost to the one or more intravascular lesions.
  • one or more endoluminal devices are advanced to an intravascular lesion to modify the intravascular lesion.
  • atherectomy can involve placing a guidewire through an intravascular lesion with a first, lesion-crossing device and subsequently advancing a second, atherectomy device to the intravascular lesion for ablation thereof.
  • advancing an endoluminal device to an intravascular lesion can lead to device complications, surgical complications, or a combination thereof—especially when a lesion-modifying tip of the endoluminal device is exposed before needed for a surgical procedure. Accordingly, there is a need to conceal lesion-modifying tips of endoluminal devices until needed for surgical procedures.
  • Provided herein in some embodiments are systems and methods that address the foregoing.
  • the catheter assembly can include a housing, a sheath, and a core wire disposed within a sheath lumen.
  • the housing can include a retraction-extension mechanism configured to retract the sheath from a first, fully extended position of the sheath, in which position a distal portion of the core wire can be wholly disposed within the sheath lumen.
  • the housing can accommodate a proximal length of the sheath, and the retraction-extension mechanism can be configured to retract the proximal length of the sheath into the housing and expose a working length of a distal portion of the core wire.
  • the core wire can include a sonic connector at a proximal end of the core wire configured to connect to an ultrasound-producing mechanism for ultrasound-based modification of one or more intravascular lesions with the working length of the core wire.
  • FIG. 1 provides a schematic illustrating a system in accordance with some embodiments.
  • FIG. 2A provides a schematic illustrating a catheter assembly with a retraction-extension mechanism configured to retract a sheath from a first, fully extended position of the sheath in accordance with some embodiments.
  • FIG. 2B provides a schematic illustrating a catheter assembly with a retraction-extension mechanism configured to extend a sheath from a second, fully retracted position of the sheath in accordance with some embodiments.
  • FIG. 3A provides a schematic illustrating a catheter assembly with a retraction-extension mechanism configured to retract a tapered sheath from a first, fully extended position of the sheath in accordance with some embodiments.
  • FIG. 3B provides a schematic illustrating a catheter assembly with a retraction-extension mechanism configured to extend a tapered sheath from a second, fully retracted position of the sheath in accordance with some embodiments.
  • FIG. 4A provides a schematic illustrating a catheter assembly with a retraction-extension mechanism configured to retract a sheath of a telescopic system from a first, fully extended position of the sheath in accordance with some embodiments.
  • FIG. 4B provides a schematic illustrating a catheter assembly with a retraction-extension mechanism configured to extend a sheath of a telescopic system from a second, fully retracted position of the sheath in accordance with some embodiments.
  • FIG. 5 provides a schematic illustrating an alternative system in accordance with some embodiments.
  • FIG. 6A provides a schematic illustrating a catheter assembly with an extension-retraction mechanism configured to extend a core wire from a first, fully retracted position of the core wire in accordance with some embodiments.
  • FIG. 6B provides a schematic illustrating a catheter assembly with an extension-retraction mechanism configured to retract a core wire from a second, fully extended position of the core wire in accordance with some embodiments.
  • any labels such as “left,” “right,” “front,” “back,” “top,” “bottom,” “forward,” “reverse,” “clockwise,” “counter clockwise,” “up,” “down,” or other similar terms such as “upper,” “lower,” “aft,” “fore,” “vertical,” “horizontal,” “proximal,” “distal,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. It should also be understood that the singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
  • proximal portion of, for example, a sheath or a core wire respectively includes a portion of the sheath or the core wire proximate to a system operator when the system is used as intended.
  • proximal length of, for example, the sheath or the core wire respectively includes a length of the sheath or the core wire proximate to the system operator when the system is used as intended.
  • proximal end of, for example, the sheath or the core wire respectively includes an end of the sheath or the core wire proximate to the system operator when the system is used as intended.
  • the proximal portion or the proximal length of the sheath or the core wire can respectively include the proximal end of the sheath or the core wire; however, the proximal portion or the proximal length of the sheath or the core wire need not respectively include the proximal end of the sheath or the core wire. That is, unless context suggests otherwise, the proximal portion or the proximal length of the sheath or the core wire is respectively not a terminal portion or a terminal length of the sheath of the core wire.
  • a “distal portion” of, for example, a sheath or a core wire respectively includes a portion of the sheath or the core wire proximate to a patient when the system is used as intended.
  • a “distal length” of, for example, the sheath or the core wire respectively includes a length of the sheath or the core wire proximate to the patient when the system is used as intended.
  • a “distal end” of, for example, the sheath or the core wire respectively includes an end of the sheath or the core wire proximate to the patient when the system is used as intended.
  • the distal portion or the distal length of the sheath or the core wire can respectively include the distal end of the sheath or the core wire; however, the distal portion or the distal length of the sheath or the core wire need not respectively include the distal end of the sheath or the core wire. That is, unless context suggests otherwise, the distal portion or the distal length of the sheath or the core wire is respectively not a terminal portion or a terminal length of the sheath of the core wire.
  • Surgical procedures for atherosclerosis such as angioplasty or atherectomy can be used to restore patency and blood flow lost to the one or more intravascular lesions.
  • one or more endoluminal devices are advanced to an intravascular lesion to modify the intravascular lesion.
  • atherectomy can involve placing a guidewire through an intravascular lesion with a first, lesion-crossing device and subsequently advancing a second, atherectomy device to the intravascular lesion for ablation thereof.
  • advancing an endoluminal device to an intravascular lesion can lead to device complications, surgical complications, or a combination thereof—especially when a lesion-modifying tip of the endoluminal device is exposed before needed for a surgical procedure. Accordingly, there is a need to conceal lesion-modifying tips of endoluminal devices until needed for surgical procedures.
  • Provided herein in some embodiments are systems and methods that address the foregoing.
  • a system including a catheter assembly.
  • the catheter assembly can include a housing, a sheath, and a core wire disposed within a sheath lumen.
  • the housing can include a retraction-extension mechanism configured to retract the sheath from a first, fully extended position of the sheath, in which position a distal portion of the core wire can be wholly disposed within the sheath lumen.
  • the housing can accommodate a proximal length of the sheath, and the retraction-extension mechanism can be configured to retract the proximal length of the sheath into the housing and expose a working length of a distal portion of the core wire.
  • the core wire can include a sonic connector at a proximal end of the core wire configured to connect to an ultrasound-producing mechanism for ultrasound-based modification of one or more intravascular lesions with the working length of the core wire.
  • FIG. 1 provides a schematic illustrating a system 100 in accordance with some embodiments.
  • the system 100 can be configured for crossing one or more intravascular lesions, ablating one or more intravascular lesions, or a combination thereof.
  • the system 100 can include a console 110 .
  • the console 110 provides a system operator an instrument for monitoring and controlling the system 100 and various sub-systems and functions thereof.
  • the console 110 can include an ultrasound-producing mechanism including an ultrasound generator 120 and an ultrasound transducer 130 .
  • the ultrasound-producing mechanism can be configured to convert an electric current into a vibrational energy.
  • the ultrasound generator 120 can be configured to convert an alternating electric current (e.g., a current associated with mains electricity) into a high-frequency current (e.g., a current with a frequency commensurate with the operating frequency of the ultrasound transducer 130 ), and the ultrasound transducer 130 , in turn, can be configured to convert the high-frequency current into the vibrational energy (e.g., >20 kHz such as 20.5 kHz ⁇ 500 Hz).
  • alternating electric current e.g., a current associated with mains electricity
  • a high-frequency current e.g., a current with a frequency commensurate with the operating frequency of the ultrasound transducer 130
  • the ultrasound transducer 130 in turn, can be configured to convert the high-frequency current into the vibrational energy (e.g., >20 kHz such as 20.5 kHz ⁇ 500 Hz).
  • the console 110 can further include a foot switch 140 configured to activate and deactivate the system 100 such as activate and deactivate a core wire 192 of a catheter assembly 160 .
  • the foot switch 140 can be used to activate the system 100 , thereby activating the core wire 192 of the catheter assembly 160 .
  • the foot switch 140 can be used to deactivate the system 100 , thereby deactivating the core wire 192 of the catheter assembly 160 .
  • the console 110 can further include an injector 150 configured to inject an irrigant into an optional irrigation lumen 172 of the catheter assembly 160 .
  • the irrigant can be, for example, sterile saline for irrigating an anatomical area undergoing an intravascular lesion-modification procedure (e.g., crossing an intravascular lesion, ablating an intravascular lesion, etc.), for cooling the core wire 192 of the catheter assembly 160 , or a combination thereof.
  • the console 110 can further include the foot switch 140 and the injector 150 .
  • the foot switch 140 can be further configured to activate and deactivate the injector 150 when the system 100 is respectively activated and deactivated with the foot switch 140 .
  • the system 100 can also include the aforementioned catheter assembly 160 .
  • the catheter assembly 160 can include a housing 170 , a sheath 182 , and the aforementioned core wire 192 disposed within a sheath lumen 183 .
  • the housing 170 can include a retraction-extension mechanism 174 configured to retract the sheath 182 from a first, fully extended position of the sheath 182 .
  • a distal portion of the core wire 192 including i) a lesion-modifying tip 194 of the core wire 192 , or ii) a lesion-modifying tip member 194 coupled to the core wire 192 can be wholly disposed within the sheath lumen 183 .
  • the retraction-extension mechanism 174 can be further configured to extend the sheath 182 from a second, fully retracted position of the sheath 182 . In the fully retracted position, a maximum working length l w(max) (see FIG.
  • FIG. 2A provides a schematic illustrating the catheter assembly 160 with the retraction-extension mechanism 174 configured to retract the sheath 182 from the first, fully extended position of the sheath 182 in accordance with some embodiments.
  • the housing 170 of the catheter assembly 160 can include the retraction-extension mechanism 174 configured to retract the sheath 182 from the first, fully extended position of the sheath 182 .
  • the distal portion of the core wire 192 can be wholly disposed with the lesion-modifying tip or tip member 194 within the sheath lumen 183 in the fully extended position of the sheath 182 .
  • FIG. 2B provides a schematic illustrating the catheter assembly 160 with the retraction-extension mechanism 174 configured to extend the sheath 182 from the second, fully retracted position of the sheath 182 in accordance with some embodiments.
  • the housing 170 of the catheter assembly 160 can include the retraction-extension mechanism 174 also configured to extend the sheath 182 from the second, fully retracted position of the sheath 182 .
  • the maximum working length l w(max) of the core wire 192 can be exposed with the lesion-modifying tip or tip member 194 outside the sheath lumen 183 in the fully retracted position of the sheath 182 .
  • the housing 170 can accommodate a proximal length of the sheath 182
  • the retraction-extension mechanism 174 can be configured to retract the proximal length of the sheath 182 into the housing 170 and expose the working length l w of the distal portion of the core wire 192 for ultrasound-based modification of one or more intravascular lesions with the working length l w of the core wire 192 .
  • a maximum working length l w(max) of the core wire 192 can be defined by a retraction distance over which a point on the sheath retracts from the first position to the second position.
  • the maximum working length l w(max) of the core wire 192 can also be defined by a slot length in the housing 170 configured to accommodate the proximal length of the sheath 182 in the second position.
  • the working length l w of the core wire 192 can range between about 5 and 200 mm, including between about 5 and 100 mm or between about 100 and 200 mm; however the working length l w of the core wire 192 is not limited thereto.
  • the retraction-extension mechanism 174 can be a hand-actuated retraction-extension mechanism, or the retraction-extension mechanism 174 can be a motor-actuated retraction-extension mechanism. Whether hand-actuated or motor-actuated, the retraction-extension mechanism 174 can be configured to i) retract the sheath 182 from the first, fully extended position of the sheath 182 , ii) extend the sheath 182 from the second, fully retracted position of the sheath 182 , iii) retract or extend the sheath 182 into intermediate positions between the first position and the second position, or iv) any combination thereof. Retraction and extension of the sheath 182 into the foregoing intermediate positions provides customizability as needed for different anatomy and intravascular lesions.
  • the core wire 192 can include a sonic connector (not shown) at a proximal end of the core wire 192 configured to connect to an ultrasound-producing mechanism for ultrasound-based modification of one or more intravascular lesions with the working length l w of the core wire 192 .
  • the sonic connector can be configured to connect to the ultrasound-producing mechanism by the ultrasound transducer 130 or an intervening ultrasonic horn (not shown).
  • a distal end of the core wire 192 can include the lesion-modifying tip 194 of the core wire 192 , or the distal end of the core wire 192 can be coupled to the lesion-modifying tip member 194 .
  • the working length l w of the distal portion of the core wire 192 beyond the sheath 182 or the sheath lumen 183 thereof can be configured for displacement to effect intravascular lesion modification.
  • the displacement can be longitudinal, transverse, or longitudinal and transverse in accordance with a profile of the core wire 192 and the vibrational energy (e.g., >20 kHz such as 20.5 kHz ⁇ 500 Hz).
  • Longitudinal displacement of the working length l w of the core wire 192 can result in micromotion such as cavitation, and transverse displacement of the working length l w of the core wire 192 can result in macromotion.
  • the micromotion can be used to cross intravascular lesions.
  • the macromotion coupled with the micromotion can be used to ablate intravascular lesions, thereby breaking the lesions into minute fragments and restoring patency and blood flow.
  • FIGS. 3A, 3B, 4A and 4B provide schematics illustrating catheter assemblies with sheath alternatives to the sheath of FIGS. 2A and 2B in accordance with some embodiments.
  • FIG. 3A provides a schematic illustrating a catheter assembly 160 with a tapered sheath 382 and a retraction-extension mechanism 174 configured to retract the tapered sheath 382 from a first, fully extended position of the sheath 382 in accordance with some embodiments.
  • FIG. 3B provides a schematic illustrating the catheter assembly 160 with the retraction-extension mechanism 174 configured to extend the tapered sheath 382 from a second, fully retracted position of the sheath 382 in accordance with some embodiments.
  • the descriptions set forth above with respect to the features of FIGS. 2A and 2B are incorporated herein by reference to describe the features of FIGS. 3A and 3B , which use the same reference numerals as FIGS.
  • a distal portion of the sheath 382 can be tapered proximate to the working length l w of the core wire 192 .
  • a sheath lumen 383 of the tapered sheath 382 can have a constant diameter to accommodate the core wire 192 and the profile thereof.
  • FIG. 4A provides a schematic illustrating a catheter assembly 160 with a sheath 482 of a telescopic system 480 and a retraction-extension mechanism 174 configured to retract the sheath 482 of the telescopic system 480 from a first, fully extended position of the sheath 482 in accordance with some embodiments.
  • FIG. 4B provides a schematic illustrating the catheter assembly 160 with the retraction-extension mechanism 174 configured to extend the sheath 482 of the telescopic system 480 from a second, fully retracted position of the sheath 482 in accordance with some embodiments.
  • the descriptions set forth above with respect to the features of FIGS. 2A and 2B are incorporated herein by reference to describe the features of FIGS.
  • the catheter assembly 160 can further include a telescopic system 480 including two or more nested telescopic members such as a first telescopic member 481 and a second telescopic member 482 . At least one telescopic member of the two or more telescopic members can be the sheath 482 . As shown, the second telescopic member 482 can be the sheath 482 . Alternatively, the two or more nested telescopic members such as the first telescopic member 481 and the second telescopic member 482 , together, form the sheath 482 .
  • a sheath lumen 483 of the sheath 482 such as the foregoing sheath 482 formed of the first telescopic member 481 and the second telescopic member 482 can have a constant diameter to accommodate the core wire 192 and the profile thereof.
  • the two or more nested telescopic members can be located in a proximal portion of the catheter assembly 160 proximate to the retraction-extension mechanism 174 .
  • FIG. 5 provides a schematic illustrating an alternative system 500 in accordance with some embodiments.
  • the system 500 can be configured for crossing one or more intravascular lesions, ablating one or more intravascular lesions, or a combination thereof.
  • the system 500 is configured to extend and retract a core wire 592 of a catheter assembly 560 instead of retract and extend a sheath 582 .
  • the system 500 can include the aforementioned catheter assembly 560 .
  • the catheter assembly 560 can include a housing 570 , the aforementioned sheath 582 , the aforementioned core wire 592 disposed within a sheath lumen 583 , and an optional irrigation lumen 572 for use with the injector 150 .
  • the housing 570 can include an extension-retraction mechanism 574 configured to extend the core wire 592 from a first, fully retracted position of the core wire 592 .
  • a distal portion of the core wire 592 including i) a lesion-modifying tip 594 of the core wire 592 , or ii) a lesion-modifying tip member 594 coupled to the core wire 592 can be wholly disposed within the sheath lumen 583 .
  • the extension-retraction mechanism 574 can be further configured to retract the core wire 592 from a second, fully extended position of the core wire 592 . In the fully extended position, a maximum working length l w(max) (see FIG.
  • FIG. 6A provides a schematic illustrating the catheter assembly 560 with the extension-retraction mechanism 574 configured to extend the core wire 592 from the first, fully retracted position of the core wire 592 in accordance with some embodiments.
  • the housing 570 of the catheter assembly 560 can include the extension-retraction mechanism 574 configured to extend the core wire 592 from the first, fully retracted position of the core wire 592 .
  • the distal portion of the core wire 592 can be wholly disposed with the lesion-modifying tip or tip member 594 within the sheath lumen 583 in the fully retracted position of the core wire 592 .
  • FIG. 6B provides a schematic illustrating the catheter assembly 560 with the extension-retraction mechanism 574 configured to retract the core wire 592 from the second, fully extended position of the core wire 592 in accordance with some embodiments.
  • the housing 570 of the catheter assembly 560 can include the extension-retraction mechanism 574 also configured to retract the core wire 592 from the second, fully extended position of the core wire 592 .
  • the maximum working length l w(max) of the core wire 592 can be exposed with the lesion-modifying tip or tip member 594 outside the sheath lumen 583 in the fully extended position of the core wire 592 .
  • the housing 570 can accommodate a proximal length of the core wire 592
  • the extension-retraction mechanism 574 can be configured to extend the proximal length of the core wire 592 from the housing 570 and expose the working length l w of the distal portion of the core wire 592 for ultrasound-based modification of one or more intravascular lesions with the working length l w of the core wire 592 .
  • a maximum working length l w(max) of the core wire 592 can be defined by an extension distance over which a point on the core wire 592 extends from the first position to the second position.
  • the maximum working length l w(max) of the core wire 592 can also be defined by a slot length l s in the housing 570 configured to accommodate the proximal length of the core wire 592 in the first position.
  • the working length l w of the core wire 592 can range between about 5 and 200 mm, including between about 5 and 100 mm or between about 100 and 200 mm; however the working length l w of the core wire 592 is not limited thereto.
  • the extension-retraction mechanism 574 can be a hand-actuated extension-retraction mechanism, or the extension-retraction mechanism 574 can be a motor-actuated extension-retraction mechanism. Whether hand-actuated or motor-actuated, the extension-retraction mechanism 574 can be configured to i) extend the core wire 592 from the first, fully retracted position of the core wire 592 , ii) retract the core wire 592 from the second, fully extended position of the core wire 592 , iii) extend or retract the core wire 592 into intermediate positions between the first position and the second position, or iv) any combination thereof. Extension and retraction of the core wire 592 into the foregoing intermediate positions provides customizability as needed for different anatomy and intravascular lesions.
  • the core wire 592 can include a sonic connector (not shown) at a proximal end of the core wire 592 configured to connect to an ultrasound-producing mechanism for ultrasound-based modification of one or more intravascular lesions with the working length l w of the core wire 592 .
  • the sonic connector can be configured to connect to the ultrasound-producing mechanism by the ultrasound transducer 130 or an intervening ultrasonic horn (not shown).
  • a distal end of the core wire 592 can include the lesion-modifying tip 594 of the core wire 592 , or the distal end of the core wire 592 can be coupled to the lesion-modifying tip member 594 .
  • the working length l w of the distal portion of the core wire 592 beyond the sheath 582 or the sheath lumen 583 thereof can be configured for displacement to effect intravascular lesion modification.
  • the displacement can be longitudinal, transverse, or longitudinal and transverse in accordance with a profile of the core wire 592 and the vibrational energy (e.g., >20 kHz such as 20.5 kHz ⁇ 500 Hz).
  • Longitudinal displacement of the working length l w of the core wire 592 can result in micromotion such as cavitation, and transverse displacement of the working length l w of the core wire 592 can result in macromotion.
  • the micromotion can be used to cross intravascular lesions.
  • the macromotion coupled with the micromotion can be used to ablate intravascular lesions, thereby breaking the lesions into minute fragments and restoring patency and blood flow.
  • the catheter assembly can include a housing, a sheath including a sheath lumen, and a core wire disposed within the sheath lumen.
  • the housing can include a retraction-extension mechanism configured to retract the sheath from a first, fully extended position of the sheath and extend the sheath from a second, fully retracted position of the sheath.
  • the retraction-extension mechanism can be further configured to retract a proximal length of the sheath into the housing and expose a working length of a distal portion of the core wire for ultrasound-based modification of one or more intravascular lesions.
  • the distal portion of the core wire can be wholly disposed within the sheath lumen while the sheath is in the first position.
  • a maximum working length of the core wire can be defined by a retraction distance over which a point on the sheath retracts from the first position to the second position.
  • the retraction distance can be defined by a slot length in the housing configured to accommodate the proximal length of the sheath in the second position.
  • a distal portion of the sheath can be tapered proximate to the working length of the core wire.
  • the retraction-extension mechanism can be a hand-actuated or motor actuated retraction-extension mechanism.
  • the catheter assembly can further include a telescopic system including two or more nested telescopic members. At least one telescopic member of the two or more telescopic members can be the sheath.
  • the system can further include a console.
  • the console can include an ultrasound-producing mechanism configured to convert an electric current into a vibrational energy.
  • a sonic connector at a proximal end of the core wire can be configured to connect to the ultrasound-producing mechanism for the ultrasound-based modification of one or more intravascular lesions.
  • the ultrasound-producing mechanism can include an ultrasonic generator, an ultrasonic transducer, and an ultrasonic horn.
  • the ultrasonic generator can be configured to convert an alternating electric current into a high-frequency current.
  • the ultrasonic transducer can be configured to convert the high-frequency current into the vibrational energy.
  • the ultrasonic horn can be configured to augment an amplitude of the vibrational energy.
  • the sonic connector of the core wire can be configured to connect to the ultrasonic horn for the ultrasound-based modification of one or more intravascular lesions.
  • the catheter assembly can include a housing, a sheath including a sheath lumen, and a core wire disposed within the sheath lumen.
  • the housing can include a retraction-extension mechanism configured to retract the sheath from a first, fully extended position of the sheath, in which position a distal portion of the core wire can be wholly disposed within the sheath lumen.
  • the retraction-extension mechanism can be further configured to extend the sheath from a second, fully retracted position of the sheath.
  • the housing can accommodate a proximal length of the sheath, and the retraction-extension mechanism can be configured to retract the proximal length of the sheath into the housing and expose a working length of a distal portion of the core wire.
  • the working length can be defined by a slot length in the housing configured to accommodate the proximal length of the sheath in the second position.
  • the core wire can include a sonic connector at a proximal end of the core wire configured to connect to an ultrasound-producing mechanism for ultrasound-based modification of one or more intravascular lesions.
  • a distal portion of the sheath can be tapered proximate to the working length of the core wire.
  • the retraction-extension mechanism can be a hand-actuated or motor-actuated retraction-extension mechanism.
  • the system can further include a console.
  • the console can include an ultrasonic generator, an ultrasonic transducer, and an ultrasonic horn.
  • the ultrasonic generator can be configured to convert an alternating electric current into a high-frequency current.
  • the ultrasonic transducer can be configured to convert the high-frequency current into the vibrational energy.
  • the ultrasonic horn can be configured to augment an amplitude of the vibrational energy.
  • the sonic connector of the core wire can be configured to connect to the ultrasonic horn for the ultrasound-based modification of one or more intravascular lesions.
  • the catheter assembly can include a housing, a sheath including a sheath lumen, and a core wire disposed within the sheath lumen.
  • the housing can include a retraction-extension mechanism configured to retract the sheath from a first, fully extended position of the sheath, in which position a distal portion of the core wire can be wholly disposed within the sheath lumen.
  • the retraction-extension mechanism can be further configured to extend the sheath from a second, fully retracted position of the sheath.
  • the housing can accommodate a proximal length of the sheath, and the retraction-extension mechanism can be configured to retract the proximal length of the sheath into the housing and expose a working length of a distal portion of the core wire for ultrasound-based modification of one or more intravascular lesions.
  • the console can include an ultrasound-producing mechanism configured to convert an electric current into a vibrational energy.
  • a sonic connector at a proximal end of the core wire can be configured to connect to the ultrasound-producing mechanism for the ultrasound-based modification of one or more intravascular lesions.
  • a maximum working length of the core wire can be defined by a retraction distance over which a point on the sheath retracts from the first position to the second position.
  • a maximum working length of the core wire can be defined by a slot length in the housing configured to accommodate the proximal length of the sheath in the second position.
  • a distal portion of the sheath can be tapered proximate to the working length of the core wire.
  • the catheter assembly can further include a telescopic system including two or more nested telescopic members. At least one telescopic member of the two or more telescopic members can be the sheath.

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  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Dentistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
US15/360,834 2016-11-23 2016-11-23 Catheter With Retractable Sheath And Methods Thereof Abandoned US20180140321A1 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
US15/360,834 US20180140321A1 (en) 2016-11-23 2016-11-23 Catheter With Retractable Sheath And Methods Thereof
US16/348,923 US11712259B2 (en) 2016-11-23 2017-05-02 Linearly actuatable catheters, systems, and methods
PCT/US2017/030675 WO2018097856A1 (en) 2016-11-23 2017-05-02 Linearly actuatable catheters, systems, and methods
JP2019547570A JP7278954B2 (ja) 2016-11-23 2017-05-02 線形作動可能なカテーテル、システム、および方法
EP17874057.7A EP3544520B1 (en) 2016-11-23 2017-05-02 Linearly actuatable catheters, systems, and fabrication methods therefor
CN201780072386.9A CN110022778B (zh) 2016-11-23 2017-05-02 可线性驱动的导管、系统和方法
PCT/US2017/060195 WO2018097953A2 (en) 2016-11-23 2017-11-06 Catheter with retractable sheath and methods thereof
US16/462,260 US11633206B2 (en) 2016-11-23 2017-11-06 Catheter with retractable sheath and methods thereof
JP2022036853A JP7303341B2 (ja) 2016-11-23 2022-03-10 線形作動可能なカテーテル、システム、および方法
US18/331,390 US20230397923A1 (en) 2016-11-23 2023-06-08 Linearly actuatable catheters, systems, and methods

Applications Claiming Priority (1)

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US15/360,834 US20180140321A1 (en) 2016-11-23 2016-11-23 Catheter With Retractable Sheath And Methods Thereof

Related Child Applications (4)

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PCT/US2017/030675 Continuation-In-Part WO2018097856A1 (en) 2016-11-23 2017-05-02 Linearly actuatable catheters, systems, and methods
US16/348,923 Continuation-In-Part US11712259B2 (en) 2016-11-23 2017-05-02 Linearly actuatable catheters, systems, and methods
US16/348,923 Continuation US11712259B2 (en) 2016-11-23 2017-05-02 Linearly actuatable catheters, systems, and methods
US16/462,260 Continuation US11633206B2 (en) 2016-11-23 2017-11-06 Catheter with retractable sheath and methods thereof

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US15/360,834 Abandoned US20180140321A1 (en) 2016-11-23 2016-11-23 Catheter With Retractable Sheath And Methods Thereof
US16/348,923 Active 2039-09-30 US11712259B2 (en) 2016-11-23 2017-05-02 Linearly actuatable catheters, systems, and methods
US16/462,260 Active 2039-08-30 US11633206B2 (en) 2016-11-23 2017-11-06 Catheter with retractable sheath and methods thereof

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US16/462,260 Active 2039-08-30 US11633206B2 (en) 2016-11-23 2017-11-06 Catheter with retractable sheath and methods thereof

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US (3) US20180140321A1 (zh)
EP (1) EP3544520B1 (zh)
JP (2) JP7278954B2 (zh)
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