WO1999035980A1 - Dispositif a catheter servant a effectuer un traitement guide d'occlusions arterielles par voie transvasculaire - Google Patents

Dispositif a catheter servant a effectuer un traitement guide d'occlusions arterielles par voie transvasculaire Download PDF

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Publication number
WO1999035980A1
WO1999035980A1 PCT/US1998/027090 US9827090W WO9935980A1 WO 1999035980 A1 WO1999035980 A1 WO 1999035980A1 US 9827090 W US9827090 W US 9827090W WO 9935980 A1 WO9935980 A1 WO 9935980A1
Authority
WO
WIPO (PCT)
Prior art keywords
locator
occlusion
worldng
catheter shaft
catheter
Prior art date
Application number
PCT/US1998/027090
Other languages
English (en)
Inventor
Matthew R. Selmon
James W. Vetter
Tomoaki Hinohara
Charles F. Milo
Original Assignee
Lumend, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/008,198 external-priority patent/US6241667B1/en
Application filed by Lumend, Inc. filed Critical Lumend, Inc.
Priority to AU20049/99A priority Critical patent/AU2004999A/en
Publication of WO1999035980A1 publication Critical patent/WO1999035980A1/fr

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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
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
    • 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
    • A61B2017/22077—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 a part piercing the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—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
    • A61B2017/22094—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 for crossing total occlusions, i.e. piercing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
    • A61B2017/308—Surgical pincettes without pivotal connections holding by means of suction with suction cups
    • 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
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
    • A61B2090/3784—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument both receiver and transmitter being in the instrument or receiver being also transmitter
    • 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
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • A61B2090/3929—Active markers

Definitions

  • This invention relates generally to catheters and more particularly to catheter apparatus for treating severe or total arterial occlusions.
  • the invention relates especially to the combination of an extravascularly operable imaging and therapeutic device and an intravascular catheter shaft.
  • Atherosclerosis is a disease in which the lumen (interior passage) of an artery becomes stenosed (narrowed) or even totally occluded (blocked) by an accumulation of fibrous, fatty, or calcified tissue. Over time this tissue, known in medicine as an atheroma, hardens and occludes the artery. In the coronary arteries, wliich supply the heart muscle, this process leads to ischemia (deficient blood flow) of the heart muscle, angina (chest pain), and, eventually, infarction (heart attack) and death.
  • a typical mechanical device for such operations is a thin, flejrible, tubular device called a catheter.
  • the catheter is introduced into a major artery, typically a femoral artery. Under fiuoroscopic observation, the catheter is advanced and steered through the arterial system until it enters the stenosed region.
  • a balloon, cutter, or other device dilates the stenosed lumen or removes atheromatous tissue.
  • Cardiac catheterization procedures for treating stenoses include percutaneous transluminal coronary angioplasty (PTCA), directional coronary atherectomy (DCA), and stenting.
  • PTCA employs a balloon to dilate the stenosis.
  • a steerable guide wire is inserted into and through the stenosis.
  • a balloon-tipped angioplasty catheter is advanced over the guide wire to the stenosis.
  • the balloon is .inflated, separating or fracturing the atheroma.
  • the lumen will remain patent for a long time. Sometimes, however, it will restenose.
  • directional coronary atherectomy a catheter, containing a cutter housed in its distal end, is advanced over the guide wire into the stenosis.
  • the housing is urged against the atheroma by the inflation of a balloon. Part of the atheroma intrudes through a window in the housing and is shaved away by the cutter.
  • Stenting is a procedure in which a wire or tubular framework, known as a stent, is compressed onto a balloon catheter and advanced over the guidewire to the stenosis. The balloon is inflated, expanding the stent. Ideally, the stent will hold the arterial lumen open for a prolonged period during which the lumen will remodel itself to a healthy, smooth configuration. Stents are often placed immediately following PTCA or DCA. It must be noted, however, that a severe stenosis may be untreatable by stenting, DCA, or PTCA.
  • the catheters used in these operations are advanced to their target over a guide wire which has already crossed the stenosis.
  • Most guide wires are too slender and soft-tipped to penetrate the calcified tissue of a severe or total occlusion.
  • most guide wires have a bent steering tip which is easily trapped or diverted by the complex, hard tissues often found in a severe stenosis.
  • neither PTCA nor DCA nor stenting is feasible and the inte.rventionist may have to refer the patient to bypass surgery.
  • degeneration makes a saphenous vein graph a rislcy and therefore undesirable site of intervention.
  • fluoroscopy a real-time X-ray technique which is widely used to position devices within the vascular system of a patient.
  • biplane fluoroscopy can be used, wherein the interventionist observes two real-time x- ray images acquired from different angles. Biplane fluoroscopy, however, is unreliable, costly and slow.
  • intravascular ultrasound which employs an ultrasonic transducer in the distal end of a catheter.
  • the catheter may be equipped with an ultraminiature, veiy high frequency scanning ultrasonic transducer designed to be introduced into the lumen of the diseased artery.
  • the stenosis is often so severe that the transducer will not fit into the part that the interventionist most urgently needs to explore. Indeed, if the occlusion is too severe to be crossed by a guide wire, it may be too difficult to steer the transducer into the segment of greatest interest. Additionally, an attempt to force an imaging catheter into a severely stenosed artery may have undesirable consequences.
  • the intravascular ultrasonic catheter can be placed in a vein adjacent the occluded artery. Because venous lumina are slightly broader than arterial lumina and rarely if ever stenosed, a larger transducer may be employed. Depending on its configuration, a larger transducer may acquire images over greater distances, with finer resolution, or both.
  • What is needed is an effective combination of a worldng element .and an imaging system for precisely crossing a severe or total coronary occlusion without causing cardiac tamponade.
  • a combination is desired which continuously displays a stable image of the atheroma, the structure of the artery, and the worlcing element as the inte.rventionist maneuvers the worldng element.
  • What is especially needed is such a combination which is deliverable and operable with minimal trauma to blood vessels and suirounding tissues.
  • an apparatus for treating arterial occlusions in accordance with the present invention comprises: a locator including an imaging tube having a proximal end zone, a distal end zone, a lumen therebetween, and an imaging device operatively disposed in the imaging tube; an elongated flexible catheter shaft, disposed in the lumen of the imaging tube, including a distal end zone and a worlcing element disposed therein, whereby the locator is extraluminally placed proximate the arterial occlusion, the worlcing element is transvascularly operable upon the occlusion, and the locator provides spatial information for effective manipulation of the worlcing element to treat the occlusion.
  • An exemplary embodiment of the catheter apparatus according to the present invention includes a steering member including a plurality of steering wires disposed in the catheter shaft.
  • the steering wires are fixed in the distal end zone of the catheter shaft, optionally attached to a retaining ring therein .and, also optionally, confined in tubes for preventing mechanical interference, and are manipulable from the proximal end of the catheter shaft.
  • the steering wires provide the apparatus of the present invention with the ability to steer the distal end of the catheter shaft, and thus the worlcing element, by applying unequal tension to different steering wires.
  • the rigid tubes have distal ends some distance proximal to the distal ends of the steering wires, thereby increasing the flexibility of the intervening segment of the distal end zone of the catheter shaft.
  • Another exemplary embodiment of the catheter apparatus according to the present invention includes a worlcing element including a pointed tissue- penetrating wire for crossing an occlusion and for penetrating the arterial wall to reach the occlusion. This provides the apparatus of the present invention with the ability to precisely select the point of entry of the worlcing element into the vascular or atheromatous tissue that is to be penetrated.
  • a worlcing element including a plurality of slots partially circumscribing the distal end zone of the catheter shaft. This provides the apparatus of the present invention with the ability to deflect the distal end of the catheter shaft with only a gentle force supplied by the steering member, while preserving the axial incompressibility of the catheter shaft and so its suitability for pushing the distal end against and through an occlusion or other tissue.
  • Another exemplary embodiment of the catheter apparatus according to the present invention includes a working element (for example, a guide wire or other tissue penetrating or treatment device) which emits a signal, and a locator which detects the signal emitted by the worlcing element, whereby a spatial relationship between the worl ing element and the locator is discernible.
  • a working element for example, a guide wire or other tissue penetrating or treatment device
  • a locator which detects the signal emitted by the worlcing element, whereby a spatial relationship between the worl ing element and the locator is discernible.
  • an extravascularly operable imaging tube having a distal end zone defining a surface including a suction coupling area for adhesion to a beating heart. This provides the apparatus of the present invention with the ability to stabilize the imaging device with respect to the blood vessels and occlusion.
  • a catheter delivery lumen terminates in an orifice proximate the acoustic window.
  • This provides the apparatus of the present invention with the ability to view an image of the catheter shaft or guide wire as it emerges from the orifice and as it is advanced through the occlusion or arterial wall.
  • Another exemplary embodiment of the catheter apparatus according to the present invention includes an extravascularly operable imaging tube having a distal end zone having a surface defining an imaging window and a plurality of suction coupling areas disposed peripherally about the window for adhesion to a beating heart.
  • a catheter delivery lumen terminates in an orifice proximate the window.
  • This provides the apparatus of the present invention with the ability to stabilize the imaging device and the catheter shaft with respect to the vessels and the occlusion while viewing an image of both and manipulating the catheter shaft and worlcing element.
  • the multiple peripherally arranged suction coupling areas provide enhanced stabilization without obstructing the imaging device or catheter shaft.
  • an exemplary embodiment of the catheter apparatus includes an acoustic transducer affixed to a transducer control shaft disposed in a lumen of the imaging tube.
  • the control shaft is mechanically manipulable by ejctemal control apparatus.
  • the transducer is operatively coupled to external signal generating and processing apparatus for displaying an image. This provides the apparatus of the present invention with the ability to display a scanning ultrasound image of the catheter shaft, worlcing element, occlusion, .and surrounding vascular and interstitial tissues as the operation is performed.
  • another exemplary embodiment of the catheter apparatus according to the present invention includes an array of acoustic transducers disposed in the imaging tube and operatively coupled to external signal generating and processing apparatus for displaying an image.
  • This provides the apparatus of the present invention with the ability to display an ultrasound image of the catheter shaft, worlcing element, occlusion and surrounding vascular and interstitial tissues as the operation is performed without necessarily employing a rotating or translating transducer control shaft. More generally, this provides an expanded imaging field, enhanced image resolution, or both, with reduced need for moving parts.
  • method for treating an arterial occlusion having a distal boundary and a proximal boundary in a human or animal body comprises the steps of: providing a apparatus for treating an arterial occlusion, the apparatus comprising: a locator including an imaging tube including a proximal end zone, a distal end zone, a lumen therebetween, and an imaging device operatively disposed in the imaging tube; and an elongated flexible catheter shaft, disposed in the lumen of the imaging tube, including a distal end zone and a worlcing element disposed therein; introducing the locator into the patient's chest, placing the distal end zone of the locator proximate the distal bound-uy of the occlusion, and activating the locator to discern the anatomical location and position of the worlcing element; while observing the anatomical location and position of the worlcing element via the locator,
  • the worlcing element is steerable and is steered within the artery under observation via the locator.
  • the worlcing element which may be, for example, a steerable catheter, a simple catheter, or a guide wire, is passed retrograde, through the occlusion, into a lumen of a separate intravascular catheter which has been placed in the arterial lumen proximal to the occlusion via femoral arteriotomy.
  • the distal end of the worlcing element which may be, for example, a steerable catheter, a simple catheter, or a guide wire, is passed retrograde, through the occlusion, into a lumen of a separate intravascular catheter which has been placed in the arterial lumen proximal to the occlusion via femoral arteriotomy.
  • JO- catheter shaft or guide wire is passed through the separate intravascular catheter to the proximal end thereof and coupled to external control apparatus, such that both ends may be simultaneously externally controlled.
  • the proximal end of the catheter shaft or guide wire is then released from its attachments and drawn into the artery to perform a therapeutic or guiding function while being controlled from the distal end.
  • catheter shaft may be provided with a highly flexible distal end zone for precise maneuvering to exploit high resolution imaging available from the extravascularly operable locator.
  • An additional advantage of the present invention is that it permits the use of cardiac catheterization techniques for restoring blood flow to severely or totally occluded coronary arteries previously inaccessible to those techniques.
  • a related advantage is that patients can enjoy relief from cardiac ischemia while avoiding the trauma of coronary bypass surgery.
  • .Another related advantage is that the native artery can be preserved and, with it, the .artery's superior blood- carrying characteristics and ability to withstand repeated surgical intervention.
  • An additional advantage of the present invention is the ability to guide a worlcing element through the tissues of a severe or total occlusion, and into the artery through the artery wall to reach the occlusion, without causing uncontrolled hemorrhage or tamponade.
  • a related advantage is the ability to provide safe access for a guide wire or other catheter to cross a severe or total occlusion.
  • An additional advantage of the present invention is the provision of a stable, real-time image of the vasculature, the disease and the worlcing element that is being guided therein, allowing accurate determination of the spatial relationships of the worl ing element, the boundaries of the occlusion, and the structures of the artery and interstitial tissues. Thus, the worlcing element can safely and accurately penetrate the occlusion.
  • An additional advantage of the present invention is the effective micro- invasive placement of the locating device in the vicinity of the occlusion, requiring only a small, minimally traumatic incision in the patient's chest.
  • An additional advantage of the present invention is the provision of a scanning ultrasound image of the catheter shaft and its anatomical environment from an imaging device which is stabilized on the surface of a beating heart. Thus, it is easier to visualize important spatial relationships while manipulating the catheter shaft and worlcing element.
  • An additional advantage of the present invention is the provision of a catheter shaft which is viewable via the imaging device immediately upon its emergence from the orifice in the imaging tube, so that it is always possible to lcnow what tissues the working element is in contact with and what tissues lie ahead.
  • An additional advantage of the present invention is the simultaneous stabilization of both the imaging device and the catheter shaft with respect to the surface of the beating heart, so that conditions are optimized for precise placement of the worlcing element through tissues.
  • An additional advantage of the present invention is the ability to simultaneously control both ends of a catheter shaft or guide wire wliich is placed in an artery.
  • An additional advantage of the present invention is the ability to introduce a catheter shaft or guide wire into an artery trans-luminally, pass the distal end of the catheter shaft or guide wire retrograde to a separate point of access to the arterial system, and either directly control both ends of the catheter shaft or guide wire simultaneously, or detach the proximal end and draw the free proximal end into the artery by directly manipulating the distal end.
  • Fig. 1 illustrates an exemplary embodiment of the apparatus in accordance with this invention placed in a human chest cavity projcimate a coronary artery having an occlusion.
  • Fig. 2 is an enlarged view of the exemplary embodiment of Fig. 1 placed proximate the occlusion.
  • Fig. 3 is an enlarged side view of an exemplary embodiment of an apparatus according to the present invention showing a catheter shaft.
  • Fig. 4 is an enlarged side view of an exemplary embodiment of an apparatus according to the present invention showing a locator and a catheter shaft disposed in a lumen of the locator.
  • Fig. 5 is a cut-away view of an exemplary embodiment of an apparatus according to the present invention proximate an occluded artery.
  • Fig. 6 is a cut-away view of an exemplary embodiment of an apparatus according to the present invention operating transvascularly to cross an arterial occlusion.
  • Fig. 7 is an enlarged side view of an exemplary embodiment of an apparatus according to the present invention showing the structure of a catheter shaft including rings and slots in the distal end zone of the catheter shaft.
  • Fig. 8 is an enlarged side view of an exemplary embodiment of an apparatus according to the present invention showing a locator including a plurality of suction coupling surface features.
  • Fig. 9 is an enlarged sectional view of an exemplary embodiment of an apparatus according to the present invention showing a locator including a plurality of suction coupling surface features.
  • Fig. 10 is an enlarged side view of an exemplary embodiment of an apparatus according to the present invention showing the structure of a catheter shaft including a signal-emitting worling element.
  • the apparatus of the present invention embodies a combination of two devices which cooperate to safely bypass the occlusion 62.
  • the first device is an imaging locator 160 including an imaging tube 162 and an imaging device 168.
  • the imaging tube 162 is introduced through a small incision (not shown) in the patient's chest and positioned adjacent the heart and proximate the occlusion 62.
  • the imaging tube 162 includes a catheter (or guide wire) delivery lumen (not shown).
  • the second device is a catheter shaft 100 including a distal end zone 104 and a steerable tissue-penetrating worlcing element 102.
  • the catheter shaft 100 is disposed in the catheter delivery lumen (not shown) of the imaging tube
  • the catheter shaft 100 and work element 102 are advanced from the catheter delivery lumen and steered and manipulated through the patient's tissues while being imaged by the locator 160.
  • the imaging tube 162 is introduced through an incision large enough to slip the imaging tube
  • the imaging tube is introduced, for example, by thoracotomy, thoracoscopy or sub-xyphoid access, is passed through a puncture in the pericardium, and is advanced until it is adjacent the surface of the heart.
  • the external imaging instruments (not shown) are then activated to display an ultrasound image.
  • the two devices are operated simultaneously to safely guide and steer the worlcing element 102 of the catheter shaft 100.
  • the locator 160 is stabilized adjacent the heart and activated to provide an image of the occlusion 62 from a vantage point close to the occluded artery 60 but outside the arterial lumen 71.
  • the catheter shaft 100 emerges from the lumen
  • the catheter shaft 100 and locator 160 are positionable with minimal trauma in the proximity of the occlusion 62 and are simultaneously operable to direct the worlcing element 102 through the arterial wall 72, into the artery 60, and through the occlusion 62.
  • the elongated flexible catheter shaft 100 (greatly shortened in Fig. 3) includes a steerable distal end zone 104 and a worlcing element 102 which is carried into the proximity of the occlusion by the distal end zone 104.
  • the proximal end zone 106 of the catheter shaft 100 is connectable to external apparatus (not shown) for manipulating the catheter shaft 100 and worlcing element 102.
  • the locator 160 includes an imaging tube 162 for micro-invasive extravascular placement of the imaging device 168 proximate the occluded artery 60.
  • the imaging tube 162 includes a proximal end zone 164 connectable to external imaging instruments (not shown).
  • the locator 160 also includes an imaging device 168 which is locatable extraluminally near the occlusion 62 and is operatively coupled to the external imaging instruments.
  • the catheter shaft 100 includes a proximal end 110 connectable to external apparatus (not shown), a distal end zone 104 including a distal end 112, and at least one lumen 114 therebetween.
  • a worlcing element 102 for penetrating tissues is disposed in the distal end zone 104.
  • a steering member 122 is disposed in the distal end zone 104 for directing the worlcing element 102 at and through tissues.
  • the steering member 122 includes a plurality of steering wires 124 slidably disposed in the catheter shaft 100.
  • the steeling wires 124 have proximal ends 126 manipulable from the proximal end
  • isolating tubes 130 slidably confine the wires 124 to prevent the wires 124 from interfering with other parts of the catheter shaft 100.
  • the steering wires 124 may be affixed to a retaining ring 132 disposed in the distal end zone 104 of the catheter shaft 100.
  • rigid tubes 136 may be disposed about isolating tubes 130, the rigid tubes 136 having distal ends 138 some distance proximal to the distal ends 128 of the steering wires 124. Between the distal ends 138 of the rigid tubes 136 and the distal end 112 of the catheter shaft 100, the absence of the rigid tubes 136 increases the flexibility of the distal end zone 104 to facilitate steeling.
  • the distal ends 128 of four steering wires 124 may be fixed in the distal end zone 104 of the catheter shaft 100 at ninety degree intervals about the longitudinal axis of the catheter shaft 100, with the result that the distal end 112 of the catheter shaft 100 can be deflected in two dimensions somewhat independently by manipulating the steering wires 124 in combination.
  • the worlcing element 102 is steered by deflecting the distal end zone 104 of the catheter shaft 100.
  • the distal end zone 104 will impart to the worlcing element 102 the deflection imparted to the distal end zone 104 by the steering member 122.
  • this deflection enables an operator of the present invention to guide the worlcing element 102 along a chosen path through the occlusion 62.
  • the apparatus may include a guide wire .and the guide wire may include a deflected distal end which functions to steer the guide wire.
  • the introduction of a worlcing element into a vascular system and the operation thereof to treat an occlusion without the specific step of steering the worlcing element during treatment is also within the scope and spirit of the method according to the present invention.
  • the present invention can incorporate a wide variety of worlcing elements.
  • a blunt-dissecting worlcing element of the kind described in copending United States Patent Application No. 08/775,264, filed February 28, 1997, the entire disclosure of wliich is incorporated herein by reference, may be used.
  • the worlcing element 104 includes a tissue- penetrating wire 116 disposed in a lumen 114 of the catheter shaft 100.
  • the tissue-penetrating wire 116 includes a proximal end 118, manipulable through the proximal end 110 of the catheter shaft 100, and a sharp distal end 120 projectable from the distal end 112 of the catheter shaft 100.
  • the tissue- penetrating wire 116 may, for example, be disposed in the lumen 114 of the catheter shaft 100 much as a trocar is disposed in a cannula.
  • the locator 160 includes an .imaging device 168 (in this embodiment, .an acoustic transducer 170), an imaging tube 162 for placing the imaging device 168 extraluminally proximate the occlusion, and one or more external imaging instruments (not shown) operatively coupled to the imaging device 168 for discerning the spatial interrelationships of the working element 102, occlusion 62, arterial lumen 71, and arterial wall 72.
  • the imaging tube 162 has an exterior surface
  • the imaging tube 162 has a suction cup activator 176 for selectively activating the suction cup 174.
  • the activator 176 includes a lumen 178 having a distal end 180 communicating with a suction cup 174 and a proximal end 182 communicating with a pressure-modulating device (not shown).
  • the activator 176 may, however, encompass an aspirator, a mechanical means of activating the suction cup 174, or any other convenient way of establishing and interrupting a vacuum to temporarily stabilize a surface of the imaging tube 162 upon a surface proximate the artery 60 and occlusion 62.
  • the suction cup may take the form of any other suction-coupling area or feature, defined by a surface 172 of the imaging tube 162, which affords adhesion to a surface.
  • the imaging tube 162 can be made flexible, enabling the distal end zone 186 of the imaging tube 162 to be secured adjacent a beating heart while the proximal end zone 164 of the imaging tube 162 remains connected to external instruments (not shown) for support and control.
  • This flexibility of the imaging tube 162 contributes to its micro-invasive quality by reducing the trauma inflicted upon tissues and by permitting the tube 162 to conforai to the natural contours of bodily surfaces.
  • the imaging tube 162 may be given a shape well suited to the route of entry into the chest, or may be stabilized or flexibly supported by external apparatus at its proximal end 188.
  • the imaging tube 162 includes a catheter delivery lumen 187 including a proximal 189 in the proximal end zone 164 of the imaging tube 162 and a distal end 191 in the distal end zone 186 of the imaging tube 162.
  • the catheter shaft 100 is slidably disposed in the lumen 187 so that, after the imaging tube 162 is stabilized on the heart surface, the catheter shaft 100 can be advanced from the lumen 187 into the appropriate bodily tissues while a stabilized image of the catheter shaft 100 and its anatomical environment is displayed via the locator 160.
  • the imaging tube 162 includes a proximal end 188, a lumen 190 originating in the proximal end 188, and a motor assembly (not shown) proximate the proximal end 188.
  • the transducer control shaft 194 is flexible enough to match the flexibility of the imaging tube 162.
  • the external imaging instruments not shown
  • acoustic signal generator-processor not shown
  • video display device controlled by a suitably programmed general purpose computer.
  • the locator 160 in this exemplary embodiment provides a scanning ultrasound image of the environment of the occlusion 62.
  • the imaging tube 162 is stabilized on the heart adjacent the artery 60 containing the occlusion 62.
  • the motor assembly (not shown) drives the transducer control shaft 194 within the lumen 190 of the imaging tube 162 in a scanning pattern appropriate for producing an image.
  • the motor assembly (not shown) may drive the transducer control shaft
  • the transducer 170 which is coupled to the transducer control shaft 194, describes a two-dimensional scanning pattern which may be registered by appropriate measuring devices as combinations of a rotational angle ⁇ and a longitudinal position Z within the imaging tube 162.
  • the acoustic signal generator-processor causes the transducer 170 to emit acoustic energy.
  • a signal conducting path 200 carries a signal (for ex.ample, an electrical signal generated or modulated by the transducer or provided for driving the transducer) from the external instruments
  • acoustic energy is of the type generally referred to as ultrasonic or ultrasound, although these terms may encompass a variety of acoustical signals embodying a variety of frequencies.
  • the energy passes through the surface 172 of the imaging tube 162 and into the occluded artery 60 and surrounding tissues.
  • the transducer 170 and acoustic signal are configured such that the energy is emitted in a narrowly focused beam 202 in a .known direction (at a known value of the angle ⁇ ) from a known position (at a lcnown v ue of Z) with respect to the imaging tube 162.
  • the transducer 170 also functions as a similarly directional acoustic signal detector, converting acoustic energy reflected by features in the environment of the imaging tube 162 to a signal which is conducted back to the signal generator- processor and measured accordingly.
  • the detected signals are associated with values of ⁇ and Z.
  • a third dimension which shall be refeired to as depth or as radius from the transducer 170 and given the letter r, is computable as a function of the time elapsed between the emission of a given signal by the transducer 170 and the detection of the echo of that signal.
  • the value detected at any given time is a function of the intensity of the echo.
  • this intensity can be reported via suitable video equipment as a two or three dimensional image of the environment of the imaging tube 162.
  • General purpose computers are programmable to accomplish this function.
  • United States Patent No. 4,794,931 the disclosure of wliich is incorporated herein by reference in its entirety, describes a computer and instrument system implementing such a function.
  • a rotating or translating scanning transducer may be supplanted by an array of directional transducers (not shown), a phased array of transducers (not shown) or other appropriately energized and interrogated set of transducers operatively connected to the external signal generator-processor for displaying the desired image.
  • the locator 160 provides an image of nearby anatomical features so that the position of the locator 160 with respect to the artery 60 and occlusion 62 is ascertained.
  • the locator 160 is manipulated until its position is ideal for imaging the vessels and tissues to be penetrated.
  • the locator 160 is then stabilized.
  • the imaging tube 162 has an exterior surface 172 which including one or more suction cups 174 for stabilizing the imaging tube 162 on tissues near the occluded artery 60.
  • the positions of the distal end 112 of the catheter shaft 100 and the distal end 120 of the worlcing element 102 are ascertained.
  • the contours of the occlusion 62 and the artery 60, as revealed by the locator 160, are also evaluated.
  • the catheter shaft 100 and locator 160 are placed proximate the occlusion 62.
  • the catheter shaft 100 includes a distal end 112, a working element 102, and a proximal end (not shown in Fig. 5).
  • the catheter shaft 100 and steering member 122 are manipulated to direct the worlcing element 102 and the catheter shaft 100 at a point of penetration of the arterial wall 72 for entry into the artery 60.
  • the point of entry 70 will have been identified in the image provided by the locator 160.
  • the image is also studied to dete ⁇ nine an appropriate path through or around the atheromatous tissues of the occlusion 62, yet staying within the artery 60.
  • a catheter shaft 100 including a steering member 122 and a tissue penetrating wire 116 is shown in Fig. 3, it should be understood that the catheter deliveiy lumen 187 may be adapted for the insertion of a catheter of simpler construction, or of a catheter lacking a steering member or discrete work element, or even for the insertion of a guide wire, into the artery. Likewise, a catheter, wire or the like so inserted may be withdrawn and another substituted in its place.
  • the invention is not limited to such a catheter shaft and the method of using the invention is not limited to the exact steps in the order described.
  • Fig. 6 illustrates the catheter shaft 100 and worlcing element 102 entering the artery 60 immediately distal to the occlusion 62 and crossing the occlusion 62 in the retrograde direction.
  • a separate intravascular catheter 103 is placed in the lumen 71 of the artery 60 proximal to the occlusion
  • This separate intravascular catheter 103 may be introduced using traditional techniques (for example, via femoral arteriotomy).
  • the separate intravascular catheter 103 has a distal end 107, a proximal end (not shown) and at least one lumen 109 therebetween.
  • the catheter shaft 100 with work element 102 (or catheter shaft, or guide wire, as the case may be) is advanced retrograde into the lumen 109 of the separate intravascular catheter 103 and is then advanced substantially to the proximal end of the separate intravascular catheter 103.
  • the distal end 112 of the catheter shaft 100 is then grasped and controlled by external apparatus (not shown).
  • the proximal end 110 of the catheter shaft 100 (shown in Fig.
  • the interventionist draws the free proximal end 110 of the catheter shaft 100 (or guide wire, as the case may be) out of the catheter delivery lumen 187, through the point of entry 70, and into the artery 60 until the prOaXimal end 110 of the catheter shaft 100 is positioned in the lumen 71 of the artery 60 distal to the occlusion 62.
  • the catheter shaft 100 (or guide wire, as the case may be) is placed across the occlusion 62 and can be used to treat the occlusion 62 or to guide other over-the-wire devices into and through the occlusion 62.
  • the occlusion 62 and the separate intravascular catheter 103 are carefully noted from the image provided by the locator 160.
  • the steering member 122 is manipulated to direct the worldng element 102 away from any contact perceived as likely to cause cardiac tamponade or other unintended trauma.
  • the distal end 112 of the catheter shaft 100 is guided through the occlusion 62 and into the separate intravascular catheter 103.
  • the catheter shaft 100 and the locator 160 of the present invention cooperate to enable the interventionist to guide the worldng element 102 into and through the occlusion 62 while .knowing the anatomical location and orientation of the catheter shaft 100 and maintaining control thereof via the catheter shaft 100 and steering member 122.
  • the occlusion 62 can be crossed safely and efficiently.
  • the s.ame cooperation enables the interventionist to pass the catheter shaft (or a guide wire) into a separately introduced intravascular catheter, providing a greater range of options for controlling and exploiting the catheter shaft or guide wire.
  • the same cooperation allows the use of what was originally the proximal end zone of the catheter shaft or guide wire to treat the occlusion or to guide other treatment devices.
  • the suction cups 174 may be released, the apparatus withdrawn from the patient, and the incision closed.
  • the micro- invasive locator 160 provides the necessary spatial infonnation for guidance of the worlcing element 102 while completely avoiding the gross trauma that would be inflicted upon the patient by a traditional bypass operation.
  • an exemplary embodiment of the present invention is shown including the above-described locator 160, catheter shaft 100, lumen 114, steering member 122, and tissue-penetrating wire 116.
  • a metal nose cone 134 is included in the distal end 112 of the catheter shaft 100 and defines a distal opening through which the tissue-penetrating wire 116 can project from the lumen 114.
  • the catheter shaft 100 can be steered via the steering member 122 and urged into the tissues along the path made by the wire 116.
  • the catheter shaft 100 can be steered via the steering member 122 and urged into the tissues along the path made by the wire 116.
  • the nose cone 134 reduces the resistance encountered by the catheter shaft 100. Progress is observed via the locator 160.
  • the distal end zone 104 of the catheter shaft 100 also includes a plurality of rings 140.
  • the rings 140 define paths 141 for the steering wires 124 (described above) of the steering member 122.
  • One or more of the rings 140 may serve to anchor the distal ends 128 of the steering wires 124.
  • the distal end zone 104 of the catheter shaft 100 also includes a plurality of slots 142 inscribed therein for increasing the steerability of the distal end zone 104.
  • unequal tension on the steeling wires 124 will deflect the distal end zone 104 and the worldng element 102 toward a wire having greater tension.
  • the slots 142 in the distal end zone 104 of the catheter shaft 100 reduce the force required to compress one side of the distal end zone 104 and extend the opposite side. A steering wire can thus more easily deflect the distal end zone 104. Because the slots 142 only partially circumscribe the distal end zone 104 of the catheter shaft 100, they do not appreciably reduce its axial stiffness. As a result, the distal end 112 of the catheter shaft may still be pushed firmly against a tissue surface at a point where the worldng element 102 is intended to enter.
  • the imaging tube 162 of the locator 160 includes an exterior surface 172 defining a plurality of suction cups 174.
  • the suction cups 174 are arrayed in two roughly parallel rows 204. Between the rows 204 is a region of the surface defining an imaging window 206.
  • the imaging window 206 includes an acoustically transparent portion of the imaging tube
  • the imaging tube 162 optionally includes a suction cup activating lumen 178 having a distal end zone 180 communicating with the suction cups 174 and a proximal end 182 coupled with a pressure modulating device (not shown).
  • the catheter delivery lumen 187 terminates proximate the imaging window 206, so that the worldng element 102 and the distal end zone 104 of the catheter shaft 100 can be observed via the imaging device 168 as they emerge from the lumen 187. In this way, it is possible to shorten the distance the catheter shaft 100 must traverse to reach from the catheter delivery lumen 187 to the artery 60 and thus to the intei ⁇ entionist's control over the catheter shaft 100.
  • an exemplary embodiment of the present invention is shown including the above-described locator 160, catheter shaft 100, lumen 114 and steering member 122.
  • the working element includes a tissue-penetrating worldng element 102 having a distal end 260.
  • a signal emitter 262 is disposed in the distal end 260.
  • a signal generator (not shown) is operatively coupled to the signal emitter 262.
  • the signal generator is external to the body and is coupled to the emitter 262 through an electrically conductive path 266 originating in the proximal end zone 106 of the catheter shaft 100 and terminating at the emitter 262. As illustrated, the electrically conductive path
  • the locator 160 includes an outer conductor 268 disposed in the catheter shaft 100, a tubular dielectric layer 270 therein, and an inner conductor 272 disposed within the dielectric layer 270.
  • any other energy-delivering or converting means can be employed to energize the emitter 262.
  • the locator 160 and emitter 262 When the locator 160 and emitter 262 are activated within the body, the locator 160 selectively detects the signal emitted by the emitter 262 in order to discern a spatial relationship between the worldng element 102 and the locator 160.
  • the signal emitter 262 may be disposed in a worlcing element which is essentially a guide wire, optionally steerable.
  • the catheter shaft may be of a simpler design than the one shown in Fig. 10; in particular, a catheter shaft without a steering member, and a signal-emitting guide wire distal end not surrounded by a separate catheter shaft, are both within the scope of the present invention.
  • the imaging device need not be an acoustic transducer and need not accomplish its imaging by scanning or mechanical movement in any particular manner.
  • the imaging device may be operatively coupled to external instruments by any appropriate mechanical, electromagnetic, optical, wave guide or other path.
  • the image that is displayed may be computed by any of a variety of algorithms for extracting one-, two-, or three-dimensional information from energy reflected, scattered or absorbed within tissues.
  • the imaging tube may be stabilized proximate the occlusion 62 by any appropriate mechanical, pneumatic, hydraulic or other means.
  • the locator 160 need not approach the heart in the particular manner described; alternative routes may be taken.
  • the steering member may include more or fewer than the two wires illustrated in the drawing figures.
  • the worldng element 102 may include any mechanical, optical, thermal, chemical, or other device for penetrating tissues, treating an occlusion, or delivering a medicament.
  • the catheter shaft may include any mechanical, optical, thermal, chemical, or other device for penetrating tissues, treating an occlusion, or delivering a medicament.

Abstract

L'invention concerne un dispositif servant à traiter des occlusions artérielles et combinant un cathéter mis en application à l'intérieur du vaisseau et possédant un élément permettant de traverser l'occlusion, et un ensemble de positionnement mis en service depuis l'extérieur du vaisseau afin de prendre l'image de l'avance de l'élément à travers l'occlusion. Des moyens d'accouplement par aspiration servent à ancrer cet ensemble de positionnement de façon amovible sur une surface située à proximité du coeur. Elle concerne un procédé servant à traiter des occlusions artérielles, ce qui consiste à faire sortir l'extrémité distale de la tige du cathéter d'une lumière de l'ensemble de positionnement, à faire pénétrer ladite extrémité dans la paroi artérielle en position distale par rapport à l'occlusion, à lui faire traverser l'occlusion dans un sens rétrograde et à l'introduire dans un cathéter intravasculaire normalisé inséré séparément, ce qui permet de manipuler ladite extrémité distale de la tige de cathéter depuis l'extrémité proximale du cathéter normalisé. On libère ensuite l'extrémité proximale de la tige de fixations extérieures et on l'introduit par traction dans l'artère afin qu'elle remplisse des fonctions de traitement ou de guidage. On observe en temps réel des rapports spatiaux réciproques par l'intermédiaire de l'ensemble de positionnement. Des éléments opérationnels coniques, abrasifs, émoussés pour la dissection, pointus, du type fil de guidage, pouvant être ou non commandés font également partie de l'invention. Celle-ci concerne, de plus, des transducteurs acoustiques et un tube d'imagerie souple pour l'ensemble de positionnement. Elle concerne enfin un élément opérationnel émettant un signal et un élément de positionnement coopérant recevant un signal.
PCT/US1998/027090 1998-01-15 1998-12-18 Dispositif a catheter servant a effectuer un traitement guide d'occlusions arterielles par voie transvasculaire WO1999035980A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU20049/99A AU2004999A (en) 1998-01-15 1998-12-18 Catheter apparatus for guided transvascular treatment of arterial occlusions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/008,198 US6241667B1 (en) 1998-01-15 1998-01-15 Catheter apparatus for guided transvascular treatment of arterial occlusions
US09/008,198 1998-01-16

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Cited By (21)

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WO2001030429A1 (fr) * 1999-10-22 2001-05-03 Scimed Life Systems, Inc. Dispositif d'injection guide
WO2001070133A2 (fr) * 2000-03-20 2001-09-27 Jan Otto Solem Procede et systeme servant a effectuer un pontage arteriel
WO2002045598A2 (fr) * 2000-12-05 2002-06-13 Lumend, Inc. Systeme de catheter pour reentree vasculaire a partir d'un espace sous-intimal
US6475226B1 (en) 1999-02-03 2002-11-05 Scimed Life Systems, Inc. Percutaneous bypass apparatus and method
WO2003030744A1 (fr) * 2001-10-09 2003-04-17 Jomed Nv Appareil et methode de pontage coronarien
WO2005055849A1 (fr) * 2003-11-27 2005-06-23 Branko Breyer Systeme a marquage ultrasonore pour dispositif d'administration d'une therapie
WO2007050941A1 (fr) * 2005-10-27 2007-05-03 Edwards Lifesciences Corporation Système, appareil, et procédé d’imagerie et de traitement de tissu
US7704222B2 (en) 1998-09-10 2010-04-27 Jenavalve Technology, Inc. Methods and conduits for flowing blood from a heart chamber to a blood vessel
US9314242B2 (en) 2000-05-01 2016-04-19 Edwards Lifesciences Corporation Single catheter heart repair device and method for use
US10869689B2 (en) 2017-05-03 2020-12-22 Medtronic Vascular, Inc. Tissue-removing catheter
US10993805B2 (en) 2008-02-26 2021-05-04 Jenavalve Technology, Inc. Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US11065138B2 (en) 2016-05-13 2021-07-20 Jenavalve Technology, Inc. Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system
US11185405B2 (en) 2013-08-30 2021-11-30 Jenavalve Technology, Inc. Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame
US11337800B2 (en) 2015-05-01 2022-05-24 Jenavalve Technology, Inc. Device and method with reduced pacemaker rate in heart valve replacement
US11357624B2 (en) 2007-04-13 2022-06-14 Jenavalve Technology, Inc. Medical device for treating a heart valve insufficiency
US11357534B2 (en) 2018-11-16 2022-06-14 Medtronic Vascular, Inc. Catheter
US11517431B2 (en) 2005-01-20 2022-12-06 Jenavalve Technology, Inc. Catheter system for implantation of prosthetic heart valves
US11564794B2 (en) 2008-02-26 2023-01-31 Jenavalve Technology, Inc. Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US11589981B2 (en) 2010-05-25 2023-02-28 Jenavalve Technology, Inc. Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
US11690645B2 (en) 2017-05-03 2023-07-04 Medtronic Vascular, Inc. Tissue-removing catheter
US11819236B2 (en) 2019-05-17 2023-11-21 Medtronic Vascular, Inc. Tissue-removing catheter

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US7704222B2 (en) 1998-09-10 2010-04-27 Jenavalve Technology, Inc. Methods and conduits for flowing blood from a heart chamber to a blood vessel
US8597226B2 (en) 1998-09-10 2013-12-03 Jenavalve Technology, Inc. Methods and conduits for flowing blood from a heart chamber to a blood vessel
US8216174B2 (en) 1998-09-10 2012-07-10 Jenavalve Technology, Inc. Methods and conduits for flowing blood from a heart chamber to a blood vessel
US7736327B2 (en) 1998-09-10 2010-06-15 Jenavalve Technology, Inc. Methods and conduits for flowing blood from a heart chamber to a blood vessel
US6475226B1 (en) 1999-02-03 2002-11-05 Scimed Life Systems, Inc. Percutaneous bypass apparatus and method
WO2001030429A1 (fr) * 1999-10-22 2001-05-03 Scimed Life Systems, Inc. Dispositif d'injection guide
WO2001070133A2 (fr) * 2000-03-20 2001-09-27 Jan Otto Solem Procede et systeme servant a effectuer un pontage arteriel
WO2001070133A3 (fr) * 2000-03-20 2002-02-28 Jan Otto Solem Procede et systeme servant a effectuer un pontage arteriel
US6585650B1 (en) 2000-03-20 2003-07-01 Jomed N.V. Method and system for bypassing an artery block
US9999419B2 (en) 2000-05-01 2018-06-19 Edwards Lifesciences Corporation Single catheter heart repair device and method for use
US9314242B2 (en) 2000-05-01 2016-04-19 Edwards Lifesciences Corporation Single catheter heart repair device and method for use
WO2002045598A3 (fr) * 2000-12-05 2003-01-16 Lumend Inc Systeme de catheter pour reentree vasculaire a partir d'un espace sous-intimal
WO2002045598A2 (fr) * 2000-12-05 2002-06-13 Lumend, Inc. Systeme de catheter pour reentree vasculaire a partir d'un espace sous-intimal
WO2003030744A1 (fr) * 2001-10-09 2003-04-17 Jomed Nv Appareil et methode de pontage coronarien
WO2005055849A1 (fr) * 2003-11-27 2005-06-23 Branko Breyer Systeme a marquage ultrasonore pour dispositif d'administration d'une therapie
US11517431B2 (en) 2005-01-20 2022-12-06 Jenavalve Technology, Inc. Catheter system for implantation of prosthetic heart valves
WO2007050941A1 (fr) * 2005-10-27 2007-05-03 Edwards Lifesciences Corporation Système, appareil, et procédé d’imagerie et de traitement de tissu
US11357624B2 (en) 2007-04-13 2022-06-14 Jenavalve Technology, Inc. Medical device for treating a heart valve insufficiency
US10993805B2 (en) 2008-02-26 2021-05-04 Jenavalve Technology, Inc. Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US11564794B2 (en) 2008-02-26 2023-01-31 Jenavalve Technology, Inc. Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US11154398B2 (en) 2008-02-26 2021-10-26 JenaValve Technology. Inc. Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US11589981B2 (en) 2010-05-25 2023-02-28 Jenavalve Technology, Inc. Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
US11185405B2 (en) 2013-08-30 2021-11-30 Jenavalve Technology, Inc. Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame
US11337800B2 (en) 2015-05-01 2022-05-24 Jenavalve Technology, Inc. Device and method with reduced pacemaker rate in heart valve replacement
US11065138B2 (en) 2016-05-13 2021-07-20 Jenavalve Technology, Inc. Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system
US11051842B2 (en) 2017-05-03 2021-07-06 Medtronic Vascular, Inc. Tissue-removing catheter with guidewire isolation liner
US10987126B2 (en) 2017-05-03 2021-04-27 Medtronic Vascular, Inc. Tissue-removing catheter with guidewire isolation liner
US10925632B2 (en) 2017-05-03 2021-02-23 Medtronic Vascular, Inc. Tissue-removing catheter
US10869689B2 (en) 2017-05-03 2020-12-22 Medtronic Vascular, Inc. Tissue-removing catheter
US11690645B2 (en) 2017-05-03 2023-07-04 Medtronic Vascular, Inc. Tissue-removing catheter
US11871958B2 (en) 2017-05-03 2024-01-16 Medtronic Vascular, Inc. Tissue-removing catheter with guidewire isolation liner
US11896260B2 (en) 2017-05-03 2024-02-13 Medtronic Vascular, Inc. Tissue-removing catheter
US11357534B2 (en) 2018-11-16 2022-06-14 Medtronic Vascular, Inc. Catheter
US11819236B2 (en) 2019-05-17 2023-11-21 Medtronic Vascular, Inc. Tissue-removing catheter

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