WO2001068178A1 - Steerable catheter - Google Patents

Steerable catheter Download PDF

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Publication number
WO2001068178A1
WO2001068178A1 PCT/US2001/007441 US0107441W WO0168178A1 WO 2001068178 A1 WO2001068178 A1 WO 2001068178A1 US 0107441 W US0107441 W US 0107441W WO 0168178 A1 WO0168178 A1 WO 0168178A1
Authority
WO
WIPO (PCT)
Prior art keywords
wire
catheter system
distal end
catheter
proximal end
Prior art date
Application number
PCT/US2001/007441
Other languages
French (fr)
Inventor
Oscar Jimenez
Jon T. Mcintyre
Edward L. Sinofsky
William H. Stanhope
Original Assignee
Cardiofocus, 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
Application filed by Cardiofocus, Inc. filed Critical Cardiofocus, Inc.
Priority to AU2001245528A priority Critical patent/AU2001245528A1/en
Publication of WO2001068178A1 publication Critical patent/WO2001068178A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0147Tip steering devices with movable mechanical means, e.g. pull wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0136Handles therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M2025/0161Tip steering devices wherein the distal tips have two or more deflection regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0144Tip steering devices having flexible regions as a result of inner reinforcement means, e.g. struts or rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0152Tip steering devices with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes

Definitions

  • the present invention relates to medical catheters, and more particularly to structures for steering the distal region of a catheter.
  • Minimally invasive surgery is a term that is often used to describe the diagnosis or treatment of a patient without the need for an extensive incision in the patient's body, and it is increasingly becoming the technique of choice for an expanding range of medical procedures.
  • Devices used in this type of surgery include a first portion that is introduced within the body through a small incision or existing body opening, and a second portion that remains outside of the body to interface with additional equipment and to provide controls for functions related to a first portion of the device.
  • a flexible catheter-type implement is required for access.
  • the catheter can be self-guiding. Other procedures require that the catheter be guided or even steerable.
  • Known steering devices include pull-wire systems wherein a wire is secured to an internal portion or structure within a catheter near its distal end, as well as to a manually manipulable member at its proximal end. The member is displaced to apply tension to the wire, pulling it in the proximal direction, thereby causing the distal tip of the catheter to bend toward the tensed wire. When the tension is reduced or released, the catheter tip will usually return to a normal (unfiexed) state.
  • pull- wire systems have utility, they also have limitations. For example, when the pull- wire is placed under tension, the plane (or azimuthal direction) of deflection of the catheter is often ill-defined. Yet another deficiency in the pull wire system is that the release of tension on the pull-wire does not necessarily ensure that the tip will return to its original position because the slack wire does not provide a restorative force to the catheter tip to reposition it. Some instrument manufacturers have attempted to address this limitation by providing a second, opposing pull-wire. However, as with a single pull-wire, a second pull-wire can also yield unpredictable deflection. Some systems include more than two wires but additional wires or other structures are undesirable because the space within the catheter lumen is scarce — especially for very small diameter catheters (e.g., 5 French or less). It is therefore desirable to obtain alternatives to pull-wire type steering systems.
  • a catheter system includes an elongate body, such as a single or multi-lumen catheter having a proximal end and a distal end.
  • First and second wires are enclosed within a lumen of the elongate body, and the wires are joined to each other at one or more points.
  • a portion of the first wire can be flattened, such as its distal region, and both the first and second wires can be made of resilient materials.
  • a spring can be provided to impart a bias force upon one or both of the wires and provide additional column strength.
  • a spring can be joined to the tip and extend over the flattened blade portion of the first wire to preclude buckling and/or ensure that the steering elements bend in a desired direction.
  • a handle unit and steering mechanism can fix the first wire at a predetermined location to prevent translatory movement of the first wire along the longitudinal axis, while permitting translatory movement of the second wire from an initial position to a forward position.
  • catheter as used herein is intended to encompass elongated probe instruments, generally, including instruments designed to travel through blood vessels, heart chambers, ducts, airways, the throat, stomach or intestines as well as instruments that are introduced into the body directly or via a trocar or large bone needle.
  • catheter is also meant to encompass endoscopes, laproscopes, culpascopes, cystoscopes and the like.
  • FIG. 1 is a simplified view of a medical system in accordance with the invention
  • FIG. 2 is a schematic illustration of the distal end of a system according to the invention configured for a Josephson type procedure
  • FIG. 3 is a schematic illustration of the distal end of a system according to the invention configured for a Cournand procedure
  • FIG. 4 is a schematic illustration of the distal end of a system according to the invention configured for an atrioventricular procedure
  • FIG. 5 is a schematic illustration of the distal end of a system according to the invention configured for a coronary sinus procedure
  • FIG. 6 is an exploded view of a catheter portion of the system of FIG. 1;
  • FIG. 7 is an exploded view of a handle portion of the system of FIG. 1;
  • FIG. 8 is a sectional view of a handle portion of FIG. 1, taken along line
  • FIG. 9 is an exploded view of a system with a removable catheter portion
  • FIG. 10 illustrates an embodiment of the invention, having an extendable catheter portion
  • FIG. 11 illustrates a system having a pre-shaped catheter in a non-deflected state
  • FIG. 12 depicts the system of FIG. 11 in a deflected state
  • FIG. 13 is a sectional view of a distal portion of the system in association with an open-tip catheter
  • FIG. 14 is a sectional view of a distal portion of an alternative configuration for an open-tip catheter.
  • FIG. 15 is a sectional view of a distal portion of a system configured for use with a radiant energy source.
  • FIG. 1 illustrates a medical system 10 in accordance with the invention that includes a handle portion 11 having a proximal end 12 and a distal end 14.
  • An elongate body 16 such as a flexible catheter, having a proximal end 18 and a distal end 20, is secured to the handle portion 11.
  • FIG. 2 shows the distal tip of the elongate body 16 configured for a Josephson Type procedure.
  • FIG. 3 depicts a configuration that is suitable for a
  • FIG. 4 illustrates a configuration suitable for treatment of the atrioventricular bundle (bundle of His); and FIG. 5 shows a configuration for the coronary sinus.
  • Exemplary devices can include an elongate body or catheter that is aboutlOO cm to 130 cm in length, with a 3 to 14 French diameter and up to a 25 cm distal curve radius.
  • FIG. 6 an exploded view of the elongate body /catheter 16 is illustrated.
  • a first wire 26 and a second wire 28 are shown within a central lumen of a flexible catheter 16.
  • the various lumens can be lined or coated with lubricious materials such as Teflon® or other fluoropolymer compositions.
  • the first and second wires, 26 and 28 respectively, are engaged or attached to each other at a point near the distal end of the catheter 16.
  • One or both wires can extend through the catheter lumen to the handle portion 11 (shown in FIG. 1).
  • wires 26 and 28 are not joined along their entire length, so that urging the second wire axially forward (toward its distal end) causes the first wire to be deflected or bent, thereby deflecting a portion of the catheter 16 to provide configurations such as those illustrated in FIGS. 2-5.
  • Wire 28 is sufficiently stiff to ensure that the axial compressive force started when it moved ("pushed") forward or is transmitted to the distal end of the catheter 16 where wires 26 and 28 are joined.
  • the "push" wire element should have a sufficiently high compressive yield strength to withstand buckling during normal manual or automated operation of the steering mechanism. This will typically require a compressive yield strength of at least about 1,000 psi.
  • wire 28 has a compressive yield strength ranging from about 10,000 psi to about
  • the first wire 26 can include a flattened portion 30, e.g., near or at its distal end, to ensure that the first wire consistently deflects in a single plane.
  • This flattened portion can be formed as an integral part of the wire by hot roller processing or other pressure applying techniques.
  • the wire 26 can have a two (or more part) construction with a ribbon-like strip welded to the wire body. It may also be advantageous to use superelastic materials, such as nitinols
  • first and second wires 26 and 28 can be rotated within the catheter lumen, in unison, by rotating the second knob 24 on the handle portion 11. Alternatively, the entire catheter 16 can be rotated.
  • the proximal end of the catheter 16 can include a jacket that is braided, wrapped or otherwise reinforced with a composite structure. In such embodiments, the distal portion would typically not include a braided jacket and/or be made of a more pliant material than the jacket near the proximal end.
  • the catheter 16 will return to its pre-deflection orientation when wire 28 is retracted back to its original position. Because wire 28 has high compressive and tensile strength, retraction will transmit a tensile force to the catheter tip thereby ensuring return of the tip to its unflexed state.
  • the wires can be made of a flexure-resilient metal, such as stainless steel or a shape memory material such as nitinol, that can return the catheter to a pre-deflection configuration without pushing or pulling on the wire.
  • a bias element such as a helical spring wrapped at about 200 turns per inch, can also be provided to provide a further restorative force.
  • a spring 32 is associated with the first wire to impart a bias force upon the first wire.
  • the spring 32 surrounds a portion of the first wire and is secured thereto.
  • the first wire 26 and the spring 32 can be located entirely within the distal half of the catheter 16.
  • the spring (or the entire wire 26) can be replaced by a hypo- tube (as shown in FIG. 16) that functions in a manner similar to the spring.
  • the flattened portion 30 can be attached to a hypo-tube 33 as the second wire 28 passes through the tube and is joined to the flattened wire end 30.
  • a short segment of the flexible (e.g., polymer) tubing 37 can be attached to the distal end of the hypotube 33 to cover the distal blade 30 and exposed portion of the second wire 28 to ensure that both bend in the same direction.
  • the working element 34 can include any of a number of devices known in the art for performing catheter based procedures.
  • the working element 34 is a spherical electrode.
  • Other examples include a radiopaque marker band or a soft tip (atraumatic).
  • Three optional ECG rings 36, 38 and 40 can be disposed on the outer surface of the catheter 16 in a spaced-apart relationship.
  • the working element can be light diffusing element for phototherapy as described in U.S. Patent 5,908,415 herein incorporated by reference.
  • FIG. 7 shows features of the handle portion 11 in a cross-sectional view.
  • the second knob 22 includes a first portion 46 that is received and rotatable within the cap 44.
  • a second portion 48 of the second knob 22 is exposed and textured so as to be readily grasped or pushed by a surgeon to rotate the second knob with respect to the handle portion as a whole.
  • a steering assembly 50 includes a bolt 52 that is secured to a lug 54 by a nut 56.
  • One or more posts 58 and 58' are disposed within sockets 60 and 60' on the lug 54 and extend outwardly therefrom.
  • the one or more posts 58 and 58' engage a spiral groove or thread 62 defined by an inner surface of the first knob 22.
  • Also receivable within the first knob 22 is a distal portion 64 of a handle unit 66.
  • the distal portion 64 includes one or more slots 68 and 68' through which posts 58 and 58' project, as is most clearly seen in FIG. 8.
  • Axial movement limits for the steering assembly 50 are established by the length of the one or more slots 68 and 68'.
  • An anchor 70 is disposed within a distal portion 72 of the handle unit 66 and is rotatable therein.
  • the second knob 24 is disposed around the distal portion of the handle unit and is secured to the handle unit 66 and the anchor 70 with a pin 74 that passes through a slot 76 in the handle unit 66.
  • the rotational limit of the second knob 24 and the anchor 70 is established by the length of the slot 76.
  • a set screw 78 is provided to inhibit rotation of the second knob 24 with respect to the handle unit 66.
  • An end plug 80 seals the handle unit and provides a passage into the handle unit 66 for wiring 82 that is in communication with a plug or connector 84, as is known in the art.
  • the proximal end of the first wire 26 passes through the end plug 42, the cap 44, and the steering assembly 50, and is fixed to the anchor 70.
  • the first wire 26 is not axially translatable.
  • the anchor is rotatable, the first wire 26 can be rotated to select a deflection plane when the second knob 24 is rotated.
  • the proximal end of the second wire 28 passes through the end plug 42 and the cap 44. But instead of being fixed with respect to the handle unit 66, the second wire 28 is secured to the steering assembly 50 and is thus axially translatable when the first knob 22 is rotated.
  • FIG. 9 illustrates a proximal portion of a flexible catheter 86 having a first lumen 88 and a second lumen 90, as well as a first wire 26, a second wire 28, and a working element 92, such as a radiant energy source.
  • the first and second wires 26 and 28 can be slid in and out of the first lumen 88; and the working element 92 can be slid in and out of the second lumen 90.
  • FIG. 10 illustrates a closed- tip catheter 94 having a lumen 96 within which are slidably disposed first and second wires 26, 28. Also shown is a lumen or passage 98 with a patient's body that has an opening 100. As illustrated, the catheter 94 has been deflected with the wires 26 and 28, as described above, to align a distal tip 102 with the opening 100. The distal tip 102 can now be advanced, as shown by the dashed lines, in a linear manner toward and into the opening 100. The distal tip 102 is similarly retracted.
  • FIG. 11 and 12 illustrate yet another feature of the catheter system that is advantageous for positioning, wherein the catheter is provided with a permanent or temporary deformation that is not related to the deflection which has been described herein.
  • FIG. 11 shows a catheter having an element 104 that imparts a selected bend to the catheter in its non-deflected state.
  • FIG. 12 illustrates the catheter in a deflected state.
  • FIG. 13 depicts yet another configuration for the invention that benefits from slidable elements. More particularly, a sectional view of a distal catheter tip is shown wherein the distal tip defines an opening 106. Also shown are a slidable working element 108 and wires 26, 28. FIG. 14 also shows an open-tip configuration, wherein a portion 110 of the tip that defines an opening 112 is tapered. Alternatively, a taper can be achieved by a step-up in the internal lumen size. The taper creates an asymmetric opening 112 useful for introducing and retracting other instruments through opening 106.
  • a catheter includes a light source 114 as a working element and substantially transparent material 116 that permits light to pass from the light source 114 to a point exterior to the catheter. Also shown is a flattened blade 30 that is polished and/or coated to make it reflective. Such reflectivity can be achieved by coating the surface of the blade 30 with a reflective metallic coating material, such as gold, or a suitable dielectric coating or by polishing the blade material itself (e.g., polished stainless steel).
  • a reflective metallic coating material such as gold, or a suitable dielectric coating

Abstract

A catheter system includes an elongate body (16) having a proximal end (12) and a distal end (14), a first wire (26) enclosed within the elongate body, and a second wire (28) enclosed within the elongate body and engaged with the first wire. Urging the second wire toward the distal end of the elongate body causes deflection of the elongate body.

Description

STEERABLE CATHETER
Background of the Invention The present invention relates to medical catheters, and more particularly to structures for steering the distal region of a catheter.
Minimally invasive surgery is a term that is often used to describe the diagnosis or treatment of a patient without the need for an extensive incision in the patient's body, and it is increasingly becoming the technique of choice for an expanding range of medical procedures. Devices used in this type of surgery include a first portion that is introduced within the body through a small incision or existing body opening, and a second portion that remains outside of the body to interface with additional equipment and to provide controls for functions related to a first portion of the device. As the site of interest within the body is often well below the skin, such as within an organ, body passage, or blood vessel, a flexible catheter-type implement is required for access. In some instances, the catheter can be self-guiding. Other procedures require that the catheter be guided or even steerable.
Various techniques and mechanical structures are known for catheter deflection and steering. Known steering devices include pull-wire systems wherein a wire is secured to an internal portion or structure within a catheter near its distal end, as well as to a manually manipulable member at its proximal end. The member is displaced to apply tension to the wire, pulling it in the proximal direction, thereby causing the distal tip of the catheter to bend toward the tensed wire. When the tension is reduced or released, the catheter tip will usually return to a normal (unfiexed) state.
Although pull- wire systems have utility, they also have limitations. For example, when the pull- wire is placed under tension, the plane (or azimuthal direction) of deflection of the catheter is often ill-defined. Yet another deficiency in the pull wire system is that the release of tension on the pull-wire does not necessarily ensure that the tip will return to its original position because the slack wire does not provide a restorative force to the catheter tip to reposition it. Some instrument manufacturers have attempted to address this limitation by providing a second, opposing pull-wire. However, as with a single pull-wire, a second pull-wire can also yield unpredictable deflection. Some systems include more than two wires but additional wires or other structures are undesirable because the space within the catheter lumen is scarce — especially for very small diameter catheters (e.g., 5 French or less). It is therefore desirable to obtain alternatives to pull-wire type steering systems.
Summary of the Invention
The present invention provides an alternative to a pull-wire catheter steering system that is more predictable. In an exemplary embodiment, a catheter system includes an elongate body, such as a single or multi-lumen catheter having a proximal end and a distal end. First and second wires are enclosed within a lumen of the elongate body, and the wires are joined to each other at one or more points. A portion of the first wire can be flattened, such as its distal region, and both the first and second wires can be made of resilient materials. A spring can be provided to impart a bias force upon one or both of the wires and provide additional column strength. For example, in one embodiment, a spring can be joined to the tip and extend over the flattened blade portion of the first wire to preclude buckling and/or ensure that the steering elements bend in a desired direction. A handle unit and steering mechanism can fix the first wire at a predetermined location to prevent translatory movement of the first wire along the longitudinal axis, while permitting translatory movement of the second wire from an initial position to a forward position. Thus, urging the second wire toward the distal end of the elongate body, from the initial position to the forward position, causes deflection of the elongate body.
The term "catheter" as used herein is intended to encompass elongated probe instruments, generally, including instruments designed to travel through blood vessels, heart chambers, ducts, airways, the throat, stomach or intestines as well as instruments that are introduced into the body directly or via a trocar or large bone needle. Similarly, the term catheter is also meant to encompass endoscopes, laproscopes, culpascopes, cystoscopes and the like.
Brief Description of the Drawings
The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
FIG. 1 is a simplified view of a medical system in accordance with the invention; FIG. 2 is a schematic illustration of the distal end of a system according to the invention configured for a Josephson type procedure;
FIG. 3 is a schematic illustration of the distal end of a system according to the invention configured for a Cournand procedure;
FIG. 4 is a schematic illustration of the distal end of a system according to the invention configured for an atrioventricular procedure;
FIG. 5 is a schematic illustration of the distal end of a system according to the invention configured for a coronary sinus procedure;
FIG. 6 is an exploded view of a catheter portion of the system of FIG. 1;
FIG. 7 is an exploded view of a handle portion of the system of FIG. 1; FIG. 8 is a sectional view of a handle portion of FIG. 1, taken along line
8-8;
FIG. 9 is an exploded view of a system with a removable catheter portion;
FIG. 10 illustrates an embodiment of the invention, having an extendable catheter portion; FIG. 11 illustrates a system having a pre-shaped catheter in a non-deflected state;
FIG. 12 depicts the system of FIG. 11 in a deflected state;
FIG. 13 is a sectional view of a distal portion of the system in association with an open-tip catheter;
FIG. 14 is a sectional view of a distal portion of an alternative configuration for an open-tip catheter; and
FIG. 15 is a sectional view of a distal portion of a system configured for use with a radiant energy source.
Detailed Description
FIG. 1 illustrates a medical system 10 in accordance with the invention that includes a handle portion 11 having a proximal end 12 and a distal end 14. An elongate body 16, such as a flexible catheter, having a proximal end 18 and a distal end 20, is secured to the handle portion 11. First and second lαiobs, 22 and
24 respectively, are provided on the handle portion 11 to control orientation and deformation of the elongate body 16, as described in greater detail below, to provide exemplary configurations as illustrated in FIGS. 2-5.
FIG. 2 shows the distal tip of the elongate body 16 configured for a Josephson Type procedure. FIG. 3 depicts a configuration that is suitable for a
Cournand Type conduction study. FIG. 4 illustrates a configuration suitable for treatment of the atrioventricular bundle (bundle of His); and FIG. 5 shows a configuration for the coronary sinus. Exemplary devices can include an elongate body or catheter that is aboutlOO cm to 130 cm in length, with a 3 to 14 French diameter and up to a 25 cm distal curve radius.
Referring now to FIG. 6, an exploded view of the elongate body /catheter 16 is illustrated. In this view, a first wire 26 and a second wire 28 are shown within a central lumen of a flexible catheter 16. Although only a single lumen catheter is shown, the invention can also include multi-lumen configurations. The various lumens can be lined or coated with lubricious materials such as Teflon® or other fluoropolymer compositions. The first and second wires, 26 and 28 respectively, are engaged or attached to each other at a point near the distal end of the catheter 16. One or both wires can extend through the catheter lumen to the handle portion 11 (shown in FIG. 1). The wires 26 and 28 are not joined along their entire length, so that urging the second wire axially forward (toward its distal end) causes the first wire to be deflected or bent, thereby deflecting a portion of the catheter 16 to provide configurations such as those illustrated in FIGS. 2-5. Wire 28 is sufficiently stiff to ensure that the axial compressive force started when it moved ("pushed") forward or is transmitted to the distal end of the catheter 16 where wires 26 and 28 are joined. Thus, the "push" wire element should have a sufficiently high compressive yield strength to withstand buckling during normal manual or automated operation of the steering mechanism. This will typically require a compressive yield strength of at least about 1,000 psi. Preferably, wire 28 has a compressive yield strength ranging from about 10,000 psi to about
250,000 psi, more preferably from at least about 20,000 psi to about 200,000 psi and most preferably, in some instances, from at least about 30,000 psi to about 150,000 psi. (It being understood that compressive strength is a function of the material, its geometry and thickness.) The first wire 26 can include a flattened portion 30, e.g., near or at its distal end, to ensure that the first wire consistently deflects in a single plane. This flattened portion can be formed as an integral part of the wire by hot roller processing or other pressure applying techniques. Alternatively the wire 26 can have a two (or more part) construction with a ribbon-like strip welded to the wire body. It may also be advantageous to use superelastic materials, such as nitinols
(nickel-titanium alloys) or spring tempered metals (e.g., stainless steel alloy 440) for the flattened portion and/or other segments of the wires 26 and 28. The specific plane or azimuthal direction of deflection is determined by the radial orientation of the flattened portion 30 of first wire 26. In various embodiments of the invention, the first and second wires 26 and 28 can be rotated within the catheter lumen, in unison, by rotating the second knob 24 on the handle portion 11. Alternatively, the entire catheter 16 can be rotated. To enhance torque control, the proximal end of the catheter 16 can include a jacket that is braided, wrapped or otherwise reinforced with a composite structure. In such embodiments, the distal portion would typically not include a braided jacket and/or be made of a more pliant material than the jacket near the proximal end.
The catheter 16 will return to its pre-deflection orientation when wire 28 is retracted back to its original position. Because wire 28 has high compressive and tensile strength, retraction will transmit a tensile force to the catheter tip thereby ensuring return of the tip to its unflexed state. As noted above, the wires can be made of a flexure-resilient metal, such as stainless steel or a shape memory material such as nitinol, that can return the catheter to a pre-deflection configuration without pushing or pulling on the wire. If necessary, a bias element, such as a helical spring wrapped at about 200 turns per inch, can also be provided to provide a further restorative force. Of course, the number of turns required to provide a tight- wrapped spring will vary in relation to the diameter of the wire used to form the spring. As shown in FIG. 6, a spring 32 is associated with the first wire to impart a bias force upon the first wire. In the illustrated embodiment, the spring 32 surrounds a portion of the first wire and is secured thereto. The first wire 26 and the spring 32 can be located entirely within the distal half of the catheter 16.
Alternatively, the spring (or the entire wire 26) can be replaced by a hypo- tube (as shown in FIG. 16) that functions in a manner similar to the spring. As shown in FIG. 16, the flattened portion 30 can be attached to a hypo-tube 33 as the second wire 28 passes through the tube and is joined to the flattened wire end 30. Optionally a short segment of the flexible (e.g., polymer) tubing 37 can be attached to the distal end of the hypotube 33 to cover the distal blade 30 and exposed portion of the second wire 28 to ensure that both bend in the same direction.
Returning to FIG. 6, at the distal tip of the catheter is a working element 34. The working element 34 can include any of a number of devices known in the art for performing catheter based procedures. In this example, the working element 34 is a spherical electrode. Other examples include a radiopaque marker band or a soft tip (atraumatic). Three optional ECG rings 36, 38 and 40 can be disposed on the outer surface of the catheter 16 in a spaced-apart relationship. Alternatively, the working element can be light diffusing element for phototherapy as described in U.S. Patent 5,908,415 herein incorporated by reference.
Turning now to FIG. 7, additional details of the handle portion 11 are shown in an exploded view. FIG. 7 should be reviewed in conjunction with FIG. 8 which shows features of the handle portion 11 in a cross-sectional view. From left to right as shown are the first wire 26, the second wire 28, an end plug 42 through which the first and second wires pass, and a cap 44 that receives the end plug. The second knob 22 includes a first portion 46 that is received and rotatable within the cap 44. A second portion 48 of the second knob 22 is exposed and textured so as to be readily grasped or pushed by a surgeon to rotate the second knob with respect to the handle portion as a whole. A steering assembly 50 includes a bolt 52 that is secured to a lug 54 by a nut 56. One or more posts 58 and 58' are disposed within sockets 60 and 60' on the lug 54 and extend outwardly therefrom. The one or more posts 58 and 58' engage a spiral groove or thread 62 defined by an inner surface of the first knob 22. Also receivable within the first knob 22 is a distal portion 64 of a handle unit 66. The distal portion 64 includes one or more slots 68 and 68' through which posts 58 and 58' project, as is most clearly seen in FIG. 8. Axial movement limits for the steering assembly 50 are established by the length of the one or more slots 68 and 68'. An anchor 70 is disposed within a distal portion 72 of the handle unit 66 and is rotatable therein. The second knob 24 is disposed around the distal portion of the handle unit and is secured to the handle unit 66 and the anchor 70 with a pin 74 that passes through a slot 76 in the handle unit 66. The rotational limit of the second knob 24 and the anchor 70 is established by the length of the slot 76.
A set screw 78 is provided to inhibit rotation of the second knob 24 with respect to the handle unit 66.
An end plug 80 seals the handle unit and provides a passage into the handle unit 66 for wiring 82 that is in communication with a plug or connector 84, as is known in the art.
In an exemplary embodiment, the proximal end of the first wire 26 passes through the end plug 42, the cap 44, and the steering assembly 50, and is fixed to the anchor 70. Thus, the first wire 26 is not axially translatable. But, because the anchor is rotatable, the first wire 26 can be rotated to select a deflection plane when the second knob 24 is rotated. As with the first wire 26, the proximal end of the second wire 28 passes through the end plug 42 and the cap 44. But instead of being fixed with respect to the handle unit 66, the second wire 28 is secured to the steering assembly 50 and is thus axially translatable when the first knob 22 is rotated. Although the elements which comprise the catheter system can be factory assembled, the system can also be configured to allow removal and replacement of the relatively less expensive catheter portion for sanitary reasons, while keeping and reusing other system components. For example, FIG. 9 illustrates a proximal portion of a flexible catheter 86 having a first lumen 88 and a second lumen 90, as well as a first wire 26, a second wire 28, and a working element 92, such as a radiant energy source. As indicated by the double-headed arrows, the first and second wires 26 and 28 can be slid in and out of the first lumen 88; and the working element 92 can be slid in and out of the second lumen 90. For some applications, it can be desirable to provide a "sliding wire" feature to assist in positioning or steering the catheter. For example, FIG. 10 illustrates a closed- tip catheter 94 having a lumen 96 within which are slidably disposed first and second wires 26, 28. Also shown is a lumen or passage 98 with a patient's body that has an opening 100. As illustrated, the catheter 94 has been deflected with the wires 26 and 28, as described above, to align a distal tip 102 with the opening 100. The distal tip 102 can now be advanced, as shown by the dashed lines, in a linear manner toward and into the opening 100. The distal tip 102 is similarly retracted. FIGS. 11 and 12 illustrate yet another feature of the catheter system that is advantageous for positioning, wherein the catheter is provided with a permanent or temporary deformation that is not related to the deflection which has been described herein. Specifically, FIG. 11 shows a catheter having an element 104 that imparts a selected bend to the catheter in its non-deflected state. FIG. 12 illustrates the catheter in a deflected state.
FIG. 13 depicts yet another configuration for the invention that benefits from slidable elements. More particularly, a sectional view of a distal catheter tip is shown wherein the distal tip defines an opening 106. Also shown are a slidable working element 108 and wires 26, 28. FIG. 14 also shows an open-tip configuration, wherein a portion 110 of the tip that defines an opening 112 is tapered. Alternatively, a taper can be achieved by a step-up in the internal lumen size. The taper creates an asymmetric opening 112 useful for introducing and retracting other instruments through opening 106.
Referring now to FIG. 15, a final configuration is illustrated, wherein a catheter includes a light source 114 as a working element and substantially transparent material 116 that permits light to pass from the light source 114 to a point exterior to the catheter. Also shown is a flattened blade 30 that is polished and/or coated to make it reflective. Such reflectivity can be achieved by coating the surface of the blade 30 with a reflective metallic coating material, such as gold, or a suitable dielectric coating or by polishing the blade material itself (e.g., polished stainless steel).
One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
What is claimed is:

Claims

Claims
1. A catheter system comprising: an elongate body having a proximal end, a distal end, and a longitudinal axis; a first wire having a proximal end and a distal end, the first wire being enclosed within the elongate body; a second wire having a proximal end and a distal end, the second wire being enclosed within the elongate body and connected to the first wire at a point within the elongate body near the distal end of the first wire; and a steering mechanism permitting relative translatory movement of the first wire with respect to the second wire; wherein urging the distal end of the second wire toward the distal end of the first wire causes deflection of the elongate body.
2. The catheter system of claim 1, wherein a portion of the first wire is flattened.
3. The catheter system of claim 2, wherein the portion of the first wire that is flattened includes the distal end of the first wire.
4. The catheter system of claim 2, wherein the first wire comprises a reflective portion.
5. The catheter system of claim 4 wherein the first wire further comprises a blade portion with a reflective coating.
6. The catheter system of claim 4 wherein the reflective portion further comprises a metallic coating.
7. The catheter system of claim 4 wherein the reflective portion further comprises a dielectric coating.
8. The catheter system of claim 1, wherein the first wire is resilient.
9. The catheter system of claim 1, wherein a spring is associated with the first wire to impart a bias force upon the first wire.
10. The catheter system of claim 9, wherein the spring is helical, and wherein the spring surrounds at least a portion of the second wire.
11. The catheter system of claim 1, wherein a spring is associated with a tubular structure to impart a bias force upon the first wire.
12. The catheter system of claim 11, wherein the tubular structure further comprises a nitinol structure.
13. The catheter system of claim 1, wherein the elongate body is a multi-lumen catheter having a diameter in the range of 3 to 14 French.
14. The catheter system of claim 1, wherein the first wire and the second wire are axially rotatable with respect to the elongate body.
15. The catheter system of claim 11 , wherein the first wire and the second wire are axially rotatable in unison.
16. The catheter system of claim 1 , wherein the first wire and the second wire are slidable along the longitudinal axis of the elongate body.
17. The catheter system of claim 1, further including an element that provides a fixed bend in the elongate body at a point between the proximal end and the distal end of the elongate body.
18. The catheter system of claim 1, further comprising a handle unit connected to the proximal end of the elongate body for housing the steering mechanism and wherein the steering mechanism further comprises an anchor that secures the proximal end of the first wire and a post secure to the proximal end of the second wire, and wherein the post is translatable within the handle unit along an axial path.
19. The catheter system of claim 18, wherein the handle unit further includes a first knob that is radially rotatable with respect to the handle unit, and wherein the first knob is engaged with the post so that rotation of the first knob causes movement of the post toward the distal end of the handle unit.
20. The catheter system of claim 19, further comprising a second knob that is radially rotatable with respect to the handle unit, and wherein the second knob is engaged with the anchor so that rotation of the second knob causes rotation of both the anchor and the post.
21. The catheter system of claim 19, wherein the handle unit includes a substantially cylindrical hollow body that defines a longitudinal aperture, wherein the post is longitudinally slidable within the substantially cylindrical hollow body, and wherein a pin extends through the longitudinal aperture.
22. The catheter system of claim 21, wherein the first knob defines a spiral groove, and wherein the pin extends into the spiral groove.
23. The catheter system of claim 1, wherein the elongate body defines an opening at its distal end.
24. The catheter system of claim 23, wherein the opening is asymmetric.
25. A catheter system comprising: a catheter portion including a catheter defining a lumen; a first wire disposed within the lumen, the first wire having a proximal end and a distal end, wherein a portion of the first wire between the proximal end and the distal end is flattened, and wherein the flattened portion is resilient; a second wire disposed within the lumen and having a proximal end and a distal end, the distal end of second wire being joined to the first wire; and a spring associated with the first wire to impart a bias force upon the first wire; and a handle unit including an anchor secured to the first wire; a post connected to the proximal end of the second wire; and a first knob that is engaged with the post to effect translatory motion of the second wire from a first initial position to a second forward position.
26. A catheter system comprising: a catheter portion including a catheter defining a lumen; a first wire disposed within the lumen, the first wire having a proximal end and a distal end, wherein a portion of the first wire between the proximal end and the distal end is flattened, and wherein the flattened portion is resilient; a second wire disposed within the lumen and having a proximal end and a distal end, the distal end of second core wire being joined to the first wire; and a helical spring surrounding a portion of the first wire; and a handle unit including an anchor that secures the first wire; a post connected to the proximal end of the second wire; a first knob that is engaged with the post to effect translatory motion of the second wire from a first initial position to a second forward position; and a second knob engaged with the anchor and the post so that radial rotation of the second knob causes rotation of both the anchor and post.
PCT/US2001/007441 2000-03-10 2001-03-08 Steerable catheter WO2001068178A1 (en)

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