US20070015964A1 - Apparatus and Methods for Coronary Sinus Access - Google Patents

Abstract

An apparatus for imaging a body structure within a body cavity includes a catheter including proximal and distal ends, an imaging element on the distal end, and an extension extending distally from the distal end for contacting a surface of a body cavity into which the catheter is introduced. The extension has a length to maintain the optical imaging element away from the surface. Optionally, a transparent member, e.g., an expandable balloon, may be attached to the distal end of the tubular member and the extension to isolate the imaging element from contact with fluid within the body cavity. During use, the catheter is inserted into a chamber of a beating heart, and the extension and/or balloon is placed against the wall of the chamber. Sufficient force is applied to stabilize the imaging element relative to the wall while the heart is beating.

Description

• This application is a continuation-in-part of co-pending application Ser. No. 11/269,976, filed Nov. 8, 2005, which is a continuation of application Ser. No. 10/447,526, filed May 29, 2003, now U.S. Pat. No. 6,979,290, which claims benefit of provisional application Ser. No. 60/384,262, filed May 30, 2002. This application also claims benefit of provisional applications Ser. Nos. 60/673,184, filed Apr. 20, 2005, and 60/678,517, filed May 6, 2005. The disclosures of each of these references is expressly incorporated by reference herein.
FIELD OF THE INVENTION
• The present invention relates generally to apparatus and methods for visualizing and/or cannulating body lumens, and, more particularly, to visualizing and cannulating a coronary sinus ostium of a heart, e.g., for delivering one or more instruments and/or fluids into coronary veins.
BACKGROUND
• Minimally invasive procedures have been implemented in a variety of medical settings, e.g., for vascular interventions, such as angioplasty, stenting, embolic protection, electrical heart stimulation, heart mapping and visualization, and the like. One such procedure involves delivering an electrical lead into a coronary vein of a patient's heart that may be used to electrically stimulate the heart.
• During such procedures, instruments, fluids, and/or medicaments may be delivered within a patient's vasculature using visualization tools, such as x-ray, fluoroscopy, ultrasound imaging, endoscopy, and the like. In many procedures, it may be desired to deliver instruments through opaque fluids, such as blood, or other materials. Endoscopes have been suggested that include devices for displacing these materials from an optical path, e.g., by introducing a clear fluid from the endoscope in an attempt to clear its field of view. Yet there are still improvements that may be made to such devices.
• Accordingly, apparatus and methods for imaging within body lumens and/or for delivering instruments and/or fluids into a patient's body would be useful.
SUMMARY OF THE INVENTION
• The present invention is directed to apparatus and methods for delivering instruments and/or fluids within a patient's body, and, more particularly, to apparatus and methods for visualizing, accessing, and/or cannulating body lumens, such as a coronary sinus ostium of a heart, e.g., for delivering electrical leads, devices, wire, or other instruments, medicaments, fluids, and/or other agents, e.g., into a coronary vein.
• In accordance with one aspect of the present invention, an apparatus is provided for locating morphological features within a body cavity that may include a flexible tubular member including a proximal end, a distal end having a size for introduction into a body cavity, and defining a longitudinal axis extending between the proximal and distal ends. An optical imaging assembly may be carried by the distal end of the tubular member for imaging beyond the distal end.
• A substantially transparent displacement member may also be carried by the distal end of the tubular member that at least partially surrounds the optical imaging assembly. In one embodiment, the displacement member may be an expandable member, e.g., a compliant or noncompliant balloon that extends from the distal end of the tubular member. Optionally, the expandable member may include a channel extending through an interior of the expandable member and/or communicating with a cannulation lumen extending through the tubular member.
• In addition, the apparatus may include a localization member slidably received in a cannulation lumen of the tubular member. The localization member may be movable beyond the distal end of the tubular member for temporarily localizing the distal end of the tubular member at a morphologic feature within a body cavity. For example, where the expandable member includes a channel communicating with the cannulation lumen, the localization member may be movable from a retracted position proximal to the surface through the channel to a deployed position beyond the surface for localizing the distal end of the tubular member. Optionally, the localization member may terminate in a distal tip configured for engaging a morphological feature, e.g., a tapered distal tip, a forked distal tip, and a steerable distal tip.
• Optionally, the apparatus may also include a capture device coupled to the proximal end of the tubular member and/or coupled to the optical imaging assembly for acquiring images obtained using the optical imaging assembly. For example, the capture device may include a display, a processor for processing the acquired images, and/or memory for storing the acquired images.
• In accordance with another aspect of the present invention, an apparatus is provided for accessing a coronary sinus ostium extending from a right atrium of a heart. The apparatus may include a flexible tubular member including a proximal end, a distal end having a size for introduction into a right atrium, and a cannulation lumen extending between the proximal and distal ends, thereby defining a longitudinal axis. A localization member may be slidably received in the cannulation lumen, the localization member being movable beyond the distal end of the tubular member for temporarily localizing the distal end of the tubular member at a morphologic feature within a body cavity.
• In addition, an array of oxygen sensors may be carried on the distal end of the tubular member for localizing a position of a coronary sinus ostium. In one embodiment, the oxygen sensors may be carried on ends of a plurality of filaments extending from the distal end of the tubular member. Alternatively, the oxygen sensors may be carried on an expandable member, e.g., a balloon, on the distal end of the tubular member.
• In a further alternative, an image sensor may be used to determine oxygen saturation by colorimetric analysis of one or more wavelengths or reflected or absorbed light.
• In accordance with yet another aspect of the present invention, an apparatus for imaging within a body lumen that may include a flexible tubular member including proximal and distal ends defining a longitudinal axis therebetween, an expandable member on the distal end of the tubular member, and an optical imaging element disposed within the interior of the expandable member, the imaging element extending from the distal end of the tubular member in a direction at least partially transversely relative to the longitudinal axis.
• In one embodiment, a channel may extend through the expandable member that communicates with a lumen extending between the proximal and distal ends of the tubular member. A source of fluid may be coupled to the proximal end of the tubular member, the source of fluid communicating with the lumen for delivering fluid through the channel to a location beyond the expandable member. In addition, or alternatively, an elongate member may be insertable through the lumen such that a distal end of the elongate member may be extended through the channel to a location beyond the expandable member.
• Preferably, the lumen and channel extend substantially concentrically along a central longitudinal axis of the tubular member. Alternatively, the lumen may extend along a periphery of the tubular member, and the channel may extend along a wall of the expandable member.
• In accordance with still another aspect of the present invention, an apparatus is provided for accessing a body lumen communicating with a body cavity that may include a flexible tubular member including a proximal end, a distal end having a size for introduction into a body cavity, and defining a longitudinal axis extending between the proximal and distal ends. An inner member may be slidably coupled to the tubular member, and a substantially transparent expandable member may be attached to the distal end of the tubular member and to a distal end of the inner member.
• The expandable member may be expandable from a contracted condition to an enlarged condition when fluid is introduced through the tubular member into an interior of the expandable member. The inner member may be slidable from a retracted position wherein a distal end of the expandable member at least partially everts into an interior of the expandable member, and an extended position wherein the expandable member defines a stabilizing element or nipple insertable into a body lumen extending from a body cavity for stabilizing the tubular member relative to the body lumen. Preferably, the apparatus also includes an optical imaging element carried by the distal end of the tubular member for imaging through the expandable member.
• In accordance with yet another aspect of the present invention, a method is provided for cannulating a body lumen communicating with a body cavity of a patient. A distal end of a tubular member may be inserted into the body cavity, the tubular member including a substantially transparent expandable member thereon in a contracted condition. The expandable member may be expanded within the body cavity, and a surface of the expandable member may be placed in contact with a wall of the body cavity in order to image the wall through the expandable member. Preferably, sufficient force is applied to clear fluid, e.g., blood, from between the surface and the wall that may otherwise obscure imaging the wall.
• The tubular member may be manipulated to move the expandable member along the wall, while imaging the wall through the expandable member, until the body lumen is identified. For example, the distal end of the tubular member may be steerable from the proximal end of the tubular member. Once the body lumen is identified, an instrument may be advanced from the tubular member into the body lumen. Alternatively, a localization member may be advanced at least partially into the body lumen to localize and/or stabilize the distal end of the tubular member.
• In a preferred embodiment, the body cavity is a right atrium of a patient's heart, and the body lumen is a coronary sinus ostium. In this embodiment, the tubular member may be advanced from a peripheral vein through a vena cava to insert the distal end into the right atrium. Once the coronary sinus is cannulated, a procedure may be performed within the coronary veins via the coronary sinus. For example, the coronary sinus may be occluded and contrast injected to obtain a venogram of the coronary veins. In addition or alternatively, a guidewire may be advanced through the tubular member into the coronary sinus, e.g., to provide a rail for other instruments. In one embodiment, an electrical lead, e.g., for a pacemaker, may be delivered into a coronary vein via the coronary sinus using the tubular member and/or instruments introduced into the coronary sinus via the tubular member and/or guidewire.
• In accordance with still another embodiment, an apparatus is provided for imaging a body structure within a body cavity that includes a flexible tubular member including a proximal end, a distal end sized for introduction into a body cavity, and a central longitudinal axis extending between the proximal and distal ends. An optical imaging element may be carried by the distal end of the tubular member for imaging beyond the distal end, and an extension is attached to the distal end and extending distally from the distal end for contacting a surface of a body cavity within which the distal end of the tubular member is introduced. The extension may have a length to maintain the optical imaging element away from the surface, thereby at least partially defining a field of view of the optical imaging element.
• In one embodiment, the extension may be a tubular member extending axially from the distal end. In another embodiment, the extension may be a substantially transparent member that isolates the optical imaging element from fluid around the distal end.
• In addition or alternatively, the apparatus may include a substantially transparent member, e.g., an expandable balloon or substantially rigid bulb, including a proximal end attached to the distal end of the tubular member and a distal end attached to the extension.
• In accordance with yet another embodiment, a method is provided for imaging structures within a body cavity. A distal end of a tubular member may be inserted into a body cavity, e.g., a chamber of a beating heart, the tubular member including an imaging element on the distal end and an extension extending distally beyond the distal end. The tubular member may be advanced until the extension contacts a surface of the body cavity, thereby disposing the optical imaging element away from the surface, and the surface may be imaged using the imaging element. In one embodiment, the body cavity may be a chamber of a beating heart, and the tubular member may be advanced with sufficient force to maintain the extension in substantially continuous contact with the surface while the heart is beating, thereby substantially stabilizing the optical imaging element relative to the surface.
• In accordance with still another embodiment, a method is provided for imaging a wall of a body cavity, e.g., a chamber of a beating heart, that includes inserting a distal end of a tubular member into the body cavity, the tubular member including a substantially transparent member extending from the distal end, placing a distal surface of the substantially transparent member against a surface of the body cavity in order to image the surface through the substantially transparent member using an optical imaging element on the distal end, and applying sufficient force to maintain the distal surface in substantially continuous contact with the surface of the body cavity for substantially stabilizing the optical imaging element relative to the surface, e.g., while the heart beats.
• Other objects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• The drawings constitute a part of this specification and include exemplary embodiments to the invention, which may be embodied in various forms. It is to be understood that in some instances various aspects of the invention may be shown exaggerated or enlarged to facilitate an understanding of the invention.
• FIG. 1A is a perspective view of a first preferred embodiment of an apparatus for cannulating a body lumen, in accordance with the present invention.
• FIG. 1B is a cross-sectional detail of a distal end of the apparatus ofFIG. 1A, showing a guidewire inserted through the apparatus.
• FIG. 1C is a cross-section of the apparatus ofFIG. 1A, taken alongline1C-1C.
• FIG. 2A is a perspective view of an alternative embodiment of the apparatus ofFIG. 1A, having two degrees of steering.
• FIG. 2B is a cross-section of the apparatus ofFIG. 2A, taken alongline2B-2B.
• FIG. 3A is a cross-sectional detail, showing an alternative embodiment of an apparatus for cannulating a body lumen including a balloon, in accordance with the present invention.
• FIGS. 3B and 3C are cross-sections of the apparatus ofFIG. 3A, taken along lines3B-3B, and3C-3C, respectively.
• FIG. 4 is a cross-sectional detail, showing another alternative embodiment of an apparatus for cannulating a body lumen including a balloon, in accordance with the present invention.
• FIGS. 5A-5C are cross-sectional side views of an embodiment of a mechanically expandable member that may be substituted for an inflatable balloon in an apparatus, in accordance with the present invention.
• FIG. 6 is a cross-sectional side view of a distal end of another embodiment of an apparatus for cannulating a body lumen, in accordance with the present invention.
• FIG. 7A is a side view of a catheter that may be included in the apparatus ofFIG. 6.
• FIG. 7B is a side view detailing a set of light guides that may be included in the catheter ofFIG. 7A.
• FIGS. 8A-8C are cross-sections of the catheter ofFIG. 7, taken alonglines8A-8A,8B-8B, and8C-8C, respectively.
• FIGS. 9A-9C are cross-sections of the light guides ofFIG. 7B, taken alonglines9A-9A,9B-9B, and9C-9C, respectively.FIG. 10 is a perspective detail of the apparatus ofFIGS. 6 and 7A, with the balloon omitted for clarity.FIGS. 11A and 11 B are exploded and perspective views of a optical fiber bundle having a lens attached thereto.FIGS. 12A-12D are partial cross-sectional views, showing a method for cannulating a body lumen communicating with a body cavity using the apparatus ofFIGS. 6-10.
• FIGS. 13A-13D show representative images that may be seen during respective steps of the cannulation method shown inFIGS. 12A-12D.
• FIG. 14 is a cross-section detail showing a balloon attached to a tubular member.
• FIG. 15 is a partial cross-sectional side view of a distal end of yet another embodiment of an apparatus including an off-axis imaging element, in accordance with the present invention.
• FIG. 16A and 16B are end views of the apparatus ofFIGS. 6 and 15, respectively, showing an improved field of view obtaining using an off-axis imaging element.
• FIGS. 17A-17F are perspective views of an alternative embodiment of an apparatus including a plurality of off-axis imaging elements.
• FIGS. 18A and 18B are cross-sectional side views of yet another embodiment of an apparatus for cannulating a body lumen, in accordance with the present invention.
• FIGS. 19A and 19B are cross-sectional side views, showing a method for cannulating a body lumen, in accordance with the present invention.
• FIGS. 20A-20C are cross-sectional side views of yet another embodiment of an apparatus for cannulating a body lumen, in accordance with the present invention.
• FIGS. 21A-21C are cross-sectional side views of still another embodiment of an apparatus for cannulating a body lumen, in accordance with the present invention.
• FIGS. 22A-22C are cross-sectional side views of yet another embodiment of an apparatus for cannulating a body lumen, in accordance with the present invention.
• FIGS. 23A and 23B are cross-sectional side views of alternative embodiments of an apparatus for cannulating a body lumen, in accordance with the present invention.
• FIGS. 24A and 24B are end views of the apparatus ofFIGS. 23A and 23B, respectively.
• FIG. 25A is a cross-sectional side view of another embodiment of an apparatus for cannulating a body lumen, in accordance with the present invention.
• FIG. 25B is an end view of the apparatus ofFIG. 25A.
• FIG. 26 is a perspective view of a computer that may be coupled to an optical imaging assembly of an apparatus, such as that shown inFIGS. 1A-1C.
• FIG. 27A is a perspective view of yet another embodiment of an apparatus for cannulating a body lumen, including a plurality of oxygen sensors, in accordance with the present invention.
• FIG. 27B is a perspective detail, showing a catheter of the apparatus ofFIG. 27A.
• FIG. 27C is a cross-sectional view of the apparatus ofFIGS. 27A and 27B, taken alongline27C-27C.
• FIG. 27D is a detail of a tubular segment extending to an oxygen sensor of the apparatus ofFIGS. 27A-27C.
• FIG. 28A is a cross-sectional side view of still another embodiment of an apparatus for cannulating a body lumen, including an oxygen center and an occlusion balloon.
• FIG. 28B is a cross-section of the apparatus ofFIG. 28A, taken along line28A-28A.
• FIGS. 29A-29C are cross-sectional views, showing a method for cannulating a coronary sinus ostium extending from a right atrium of a heart, in accordance with the present invention.
• FIGS. 30A-30C are details, showing alternate tips of a stabilization member that may be included in the apparatus shown inFIGS. 29A-29C.
• FIG. 31 is an exploded side view of a proximal end of an apparatus, showing of a flexible connector, coupled between a camera and a circuit board, to accommodate axial movement of the camera.
• FIGS. 32A and 32B are cross-sections of alternative configurations of a catheter that may include an imaging fiber or a guidewire lumen, respectively, that may be used as a pull wire.
• FIGS. 33A-33C are side views showing a method for constructing a light source for an imaging catheter.
• FIG. 34 is a cross-sectional view of a portion of a heart, showing a catheter navigating the coronary sinus ostium.
• FIG. 35 is a cross-sectional view of a portion of a heart, showing a catheter cannulating and stabilizing in the coronary sinus ostium as a distal force “F “is being applied.
• FIG. 36 is a cross-sectional view of a portion of a heart, showing a catheter conforming to an anatomical opening such as the coronary sinus ostium, as a distal force “F” is being applied.
• FIGS. 37 and 38 are cross-sectional views of a portion of a heart, showing a catheter locating the coronary sinus ostium without or using contrast agent, respectively, which may facilitate imaging using a fluoroscope (not shown).
• FIGS. 39-41 are side views of distal ends of alternative embodiments of an apparatus for imaging tissue (FIG. 39) and/or cannulating a body lumen (FIG. 41).
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Turning to the drawings,FIGS. 1A-1C show a first preferred embodiment of anapparatus10 for imaging a body lumen, e.g., for visualizing, accessing, and/or cannulating a body lumen from a body cavity (not shown). In a preferred embodiment, as explained further below, theapparatus10 may be used for imaging a wall of a right atrium of a heart, e.g., for visualizing, accessing, and/or cannulating a coronary sinus ostium, although theapparatus10 may be used for visualizing, accessing, and/or cannulating other body lumens as well. Generally, as shown inFIG. 1A, theapparatus10 may include a catheter or otherelongate member12, a balloon or otherexpandable member50 on adistal end16 of thecatheter12, and animaging assembly62 carried by thedistal end16 of thecatheter12 for imaging through theballoon50.
• Thecatheter12 generally is an elongate tubular body including aproximal end14, adistal end16 having a size and shape for insertion into a patient's body, and a centrallongitudinal axis18 extending between the proximal and distal ends14,16. Thecatheter12 may include one or more lumens20 also extending between the proximal and distal ends14,16, e.g., acannulation lumen20a, aninflation lumen20b, and one ormore lumens20c,20d(best seen inFIG. 1C) for theimaging assembly62.
• Thecatheter12 may be substantially flexible, semi-rigid, and/or rigid along its length, and may be formed from a variety of materials, including plastic, metal and/or composite materials, as is well known to those skilled in the art. For example, thecatheter12 may be substantially flexible at thedistal end16 to facilitate advancement through tortuous anatomy, and/or may be semi-rigid or rigid at theproximal end14 to enhance pushability of thecatheter12 without substantial risk of buckling or kinking.
• Preferably, thecatheter12 is steerable, i.e., thedistal end16 may be controllably deflected transversely relative to thelongitudinal axis18. In the embodiment shown inFIGS. 1A-1C, a single pullwire orother steering element22 may be provided, e.g., within one of the lumens20, for steering thedistal end16 of thecatheter12 in one transverse plane (thereby providing one degree of freedom). Alternatively, in another embodiment, such as that shown inFIGS. 2A and 2B, twopullwires22′ may be provided for steering thedistal end16′ of thecatheter12′ in two orthogonal planes (thereby providing two degrees of freedom).
• The pullwire(s)22 may be a cable, wire, band, and the like that may be slidably disposed within a lumen, such as theinflation lumen20bshown inFIG. 1C. The pullwire(s)22 may be attached or otherwise fixed relative to thecatheter12 at a location adjacent thedistal end16, preferably offset radially outwardly from thecentral axis18. Thus, when thepullwire22 is pulled proximally, e.g., from theproximal end14 of thecatheter12, a bending force may be applied to thedistal end16, causing thedistal end16 to bend transversely relative to thecentral axis18.
• Thecatheter12 may also include a handle orother control mechanism30 coupled to or otherwise provided on theproximal end14 of thecatheter12. Thehandle30 may include one or more steering controls32 that may be actuated to steer thedistal end16 of thecatheter12. For example, as shown inFIG. 1, adial32 may be provided that may be coupled to thepullwire22. Thedial32 may be rotated to apply a proximal force on thepullwire22, thereby bending thedistal end16 of thecatheter12. In a further alternative, thesteering control32 may include a slider coupled to a pullwire (not shown) such that translation of the slider translates the pullwire, causing deflection of the distal tip of thecatheter12 as the pullwire is placed in tension or compression. Exemplary embodiments of steering controls are disclosed in application Ser. No. 11/062,074, filed Feb. 17, 2005, the entire disclosure of which is expressly incorporated by reference herein.
• Optionally, one or more elements of theimaging assembly62, e.g., the imaging fiber and/or light guide (described elsewhere herein) may be used as a pullwire. For example, as shown inFIG. 31, an image sensor5 may be coupled to animaging fiber3 that also function as a pullwire within ahandle30 of the apparatus10 (not shown; see, e.g.,FIG. 1). A slider4 may be coupled to theimaging fiber3 enabling the user to steer adistal end16 of the apparatus10 (not shown; see, e.g.,FIG. 1) by translating theimaging fiber3. In embodiments where the image sensor5 is coupled to aseparate circuit board2, aflexible connector1 may be used to couple the image sensor5 to thecircuit board2. Theflexible connector1 may be sufficiently long and flexible to accommodate axial translation of the image sensor5 relative to thecircuit board2 when theimaging fiber3 is moved during steering. In an exemplary embodiment, theflexible connector1 may be fabricated from fiberglass, polyimide, and the like and may have appropriate electrical traces and/or connectors for electrically coupling the image sensor5 to thecircuit board2, as are known to those skilled in the art. Alternatively, the entire camera (e.g., including an image sensor5 and any circuitry, such as circuit board2) may be slidably disposed within thehandle30. In a further alternative, theimaging fiber3 may be sufficiently flexible to accommodate proximal bending during axial translation of theimaging fiber3 relative to thecircuit board2.
• In addition or alternatively, if the imaging and/or light guide fibers are used as one or more pull wire(s), the fibers may located towards a periphery of the apparatus (includingcatheter12 shown inFIG. 1), e.g., to maximize the available field of view for imaging. Alternatively, the pullwire(s) may be disposed in the guidewire lumen, which may reduce the cross sectional size of the apparatus, while allowing the imaging fiber to remain as close to the periphery as possible. For example, as shown in FIGS.32A(1) and32A(2), one or more pull wires la may be located above theimage fiber2aandlight guide3a, e.g., in unused portion of thecatheter12. Optionally, a flat and/or arcuate ribbon may also be provided for use as a pull wire (not shown).
• Alternatively, as shown inFIG. 32B, thecatheter12″ may include aninner guidewire lumen32athat movable within anouter guidewire lumen32b, thereby acting as a pull wire. For example, theinner guidewire lumen32amay be bonded to theouter guidewire lumen32bof thecatheter12″ only at the distal end so that theinner guidewire lumen32amay serve as the pull wire and/or tip deflection member.
• In addition or alternatively, as shown inFIGS. 2A and 2B, adial32a′ and/or atrigger32b′ may be provided on thehandle30′ that may be coupled torespective pullwires22a,′22b.′ Thus, thedial32′ may be rotated to bend thecatheter12′ in a first direction and thetrigger32b′ may be pulled to bend thecatheter12′ in a second direction, preferably substantially perpendicular to the first direction. The steering control(s) may be biased, e.g., to return thedistal end32 or32′ of thecatheter12 or12′ to a generally straight configuration when the control(s) is(are) released. Alternatively, each steering control may be coupled to a pair of opposing pullwires opposite one another relative to the central axis (not shown) such that actuating the control in one direction bends the distal end one direction, while actuating the control in an opposite direction bends the distal end in an opposite direction. It will be appreciated that other control mechanisms and/or steering arrangements may be provided, including one, two, or more degrees of freedom, as are well known to those skilled in the art.
• Thehandle30 may also include ports and/or other connections for connecting other components to thecatheter12. It will be appreciated that any known connectors may be provided for permanently or temporarily connecting components to thecatheter12. For example, a luer lock connector may be used to connect tubing or other fluid-conveying components to thehandle30.
• As shown inFIG. 1A, a syringe or other source offluid34, e.g., including saline, carbon dioxide, nitrogen, or air, may be connected via tubing36 to theinflation lumen20b(not shown, seeFIG. 1C) for inflating theballoon50. In addition or alternatively, a stop-cock or check valve (not shown) may be included in the path of theinflation lumen20bto selectively maintain balloon inflation. For example, a luer-activated check valve may be used, such that a luer-lock syringe34 may be engaged with theapparatus10 to open the valve for balloon inflation or deflation. When thesyringe34 is removed, the check valve may automatically close to maintain balloon inflation. Thesyringe34 may also provide a source of vacuum for deflating theballoon50, as is known in the art. Another source offluid38, e.g., saline, and/or a therapeutic or diagnostic agent, may be connected viatubing40 to thecannulation lumen20afor delivering fluid beyond thedistal end16 of thecatheter12.
• In addition, anaccess port42 may also communicate with thecannulation lumen20a, e.g., including a hemostatic seal and the like (not shown), for delivering one or more instruments (such asguidewire80, shown inFIG. 1B) through thecannulation lumen20a, as explained further below. Optionally, thehandle30 may include a shape, size, and/or contour (not shown) for facilitating manipulating thecatheter12 during use.
• Returning toFIGS. 1A and 1B, a substantiallytransparent balloon50 may be provided on thedistal end16 of thetubular member12. Theballoon50 may be expandable from a contracted condition (not shown) to an enlarged condition when fluid is introduced into an interior60 of theballoon50. In the embodiment shown, achannel52 may extend through theballoon50 that communicates with a lumen20 of thecatheter12, e.g., thecannulation lumen20a. Preferably, thechannel52 extends through theballoon50 concentrically with thecentral axis18, as best seen inFIG. 1B.
• In an exemplary embodiment, theballoon50 may be formed from substantially noncompliant material, e.g., polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), fluorinated ethylenepropylene (FEP), polyethylene teraphathalate (PET), urethane, olefins, and polyethylene (PE), such that theballoon50 may expand to a predetermined shape when fully inflated to the enlarged configuration. Preferably, in the enlarged configuration, theballoon50 may have adistal surface54 that is substantially flat or otherwise configured for contacting a wall of a body cavity, such as the right atrium (not shown). Alternatively, as shown inFIGS. 19A and 19B, anapparatus710 may be provided that carries aballoon750 having a frustoconical shape and/or a convexdistal surface754.
• The material may be sufficiently flexible and/or elastic such that thedistal surface54 may conform substantially to the wall of the body cavity. Preferably, theballoon50 is also sufficiently noncompliant to displace blood or other fluid from between thedistal surface54 and the wall of the body cavity to facilitate imaging the wall through theballoon50, as explained further below. Alternatively, theballoon50 may be formed from compliant and/or elastomeric materials, such as silicone, latex, isoprene, and chronoprene.
• In the exemplary embodiment shown inFIG. 1B, theballoon50 may be formed from one or more panels that may be attached to one another, e.g., using an adhesive (such as an adhesive cured using ultraviolet (“UV”) light), sonic welding, and/or heating, after lapping or butting adjacent panels together. Alternatively, theballoon50 may be molded around or within a mold (not shown) having a desired shape for theballoon50 in the enlarged condition.
• The resultingballoon50 may include aproximal end56 that may be attached to an outer surface of thecatheter12, e.g., using an adhesive, heating, sonic welding, an interference fit, and/or an outer sleeve. Thechannel52 may be formed from the same material as the rest of theballoon50, and aproximal end58 of the channel may be attached to thedistal end16 of thecatheter12, e.g., within or concentric with thecannulation lumen20a. Alternatively, the channel may be formed from a semi-rigid or rigid tubular member, as shown inFIGS. 6-10, and described further below.
• In another alternative, thechannel52 may be formed of one or more materials to provide a stiffness transition or multiple transitions. In a further alternative, thechannel52 may be flexible or semi-flexible, but also biased and/or constrained in on or more directions, e.g., to avoid or minimize deflection of thechannel52 into a position that may obscure the field of view beyond theapparatus10. In still another alternative, thechannel52 may be transparent or semi-transparent to light in the spectra used for imaging, e.g., to facilitate visualization of devices, instruments, agents, and/or fluids passing through the tubular member. Alternatively, thechannel52 may be replaced or reinforced with any suitable stiffening element such as a wire, spring, composite element, plastic element, and the like.
• As best seen inFIG. 1B, theinterior60 of theballoon50 may have a generally annular shape that preferably communicates with theinflation lumen20b(not shown, seeFIG. 1C) of thecatheter12. Substantially transparent inflation media, e.g., saline, carbon dioxide, nitrogen, air, and the like, may be introduced into the interior60 of theballoon50 to expand theballoon50 towards the enlarged condition shown inFIGS. 1A and 1B. As used herein, “transparent” refers to any material and/or fluid that may permit sufficient light to pass therethrough in order to identify or otherwise visualize objects through the material and/or fluid. “Light” as used herein may refer to light radiation within the visible spectrum, but may also include other spectra, such as infrared (“IR”) or ultraviolet (“UV”) light.
• Alternatively, the balloon and/or channel may have different configurations, such as that shown inFIGS. 3A-3C and4. For example, as shown inFIGS. 3A-3C, anapparatus110 is shown that includes acatheter112 that may include one or more lumens, e.g.,lumens120c,120dfor receiving components of an imaging assembly162 therethrough, similar to the previous embodiment. Unlike the previous embodiment, acannulation lumen120aextends along an outer surface of thecatheter112 that extends between a proximal end (not shown) to adistal end116 of thecatheter112. Thelumen120amay be a separate tubular member attached to thecatheter112 or may be an integral part of thecatheter112, e.g., formed as a single extrusion.
• Aballoon150 may be carried on thedistal end116 of thecatheter112 that defines an interior160 communicating with an inflation lumen (not shown) that extends to the proximal end of thecatheter112, similar to the previous embodiment. Achannel152 may extend along a wall of theballoon150 that communicates with thecannulation lumen120a. Thechannel152 may be defined by a panel of material attached to theballoon150, similar to the materials and methods for makingballoon50, as described above. Alternatively, an inner balloon panel may be provided within an outer balloon panel and the panels may be attached to one another, e.g., along one or more seams defining thechannel152.
• A nipple orannular collar157 may be provided on thedistal surface154 of theballoon150, e.g., to guide aguidewire80 or other instrument out of theballoon150, and/or to stabilize the device relative to a body lumen or other tissue structure (not shown). Thus, aguidewire80 may be inserted into thecannulation lumen120afrom the proximal end of thecatheter112, thechannel152 guiding theguidewire80 through theballoon150 until it exits through thenipple157 to a location beyond thedistal surface152 of theballoon150.
• In another alternative, shown inFIG. 4, aninner balloon251 may be provided within an interior260 of anouter balloon250. Theinner balloon251 may be expandable to a size and/or shape that is smaller than theouter balloon250, thereby defining achannel252 between theballoons251,252. Thus, aguidewire80 or other instrument (not shown) may be inserted into acannulation lumen220a, e.g., extending along an outer surface of the catheter212. Theguidewire80 may enter thechannel252 between theballoons251,252 until it exits through anipple257, similar to the embodiment shown inFIGS. 3A-3C.
• In a further alternative, a balloon may be provided without a channel extending therethrough, as shown, for example, inFIGS. 20A-22C, and described further below.
• In yet another alternative, shown inFIGS. 5A-5C, anapparatus310 may be provided that includes a mechanicallyexpandable member350 carried on adistal end316 of acatheter312. Aframe352 may be coupled to thedistal end316 that may support a substantially transparent,flexible membrane354. Theframe352 may include a plurality of members that are movable away from and towards one another, thereby causing themembrane354 to move between contracted and enlarged conditions. Alternatively, theframe352 may be constructed of plastic or wire mesh, or of a laser cut expandable framework.
• Theframe352 may be actuated from a proximal end (not shown) of thecatheter312, e.g., to cause theframe352 to expand radially outwardly, as shown inFIGS. 5B and 5C. As theframe352 expands, themembrane354 may provide a substantiallytransparent surface356 through which an optical imaging assembly, e.g., including anoptical fiber bundle364 and/or alight guide368, similar to that described further below, may obtain optical images. Optionally, an interior358 of themembrane354 may be filled with a substantially transparent fluid, similar to the balloons described above, to facilitate imaging through theexpandable member350.
• Returning toFIGS. 1A-1C, theimaging assembly62 generally includes anoptical imaging element64 that is exposed within theinterior60 of theballoon50 for capturing light images through theballoon50. In one embodiment, the optical imaging element comprises an image sensor such as a CCD, CMOS, and the like disposed distally, e.g., adjacent or within thedistal end16. In another embodiment, theoptical imaging element64 may include a bundle of optical fibers, e.g. a coherent image bundle, that extends between the proximal and distal ends14,16 of thecatheter12, e.g., through thelumen20d, as shown in FIG. IC. Thefiber bundle64 may include about ten thousand (10,000) optical fibers, although it may include between about one and fifty thousand (1,000-50,000) fibers in order to provide a desired resolution in the images obtained by thefiber bundle64.
• Alens66, e.g., a GRIN or self-oc lens, may be coupled to thefiber bundle64 in order to focus light from beyond thedistal surface54 of theballoon50 onto thefiber bundle64 in order to generate a resolved image at the proximal end of thefiber bundle64, as is well known to those skilled in the art. Optionally, a directional prism or other optical element (not shown) may be provided for directing a field of view of thefiber bundle64 as desired, as explained further below. In order to decrease the tendency of bubbles to adhere to the distal surface of a distal lens or other optical element (not shown), the lens may be coated with a hydrophilic coating, or designed such that its geometry or the surrounding catheter geometry decreases the tendency of bubbles to adhere, e.g., by providing a convex exposed surface. Other features, such as directed flushing, may be employed to dislodge any adhered bubbles during use.
• In addition, theimaging assembly62 may include one or more light sources disposed at thedistal end16 of thecatheter12. For example, the light sources may be one or more light emitting diodes. Alternatively, theimaging assembly62 may include one or more light guides68 carried by thedistal end16 of thecatheter12 for delivering light into the interior60 and/or through thedistal surface54 of theballoon50. Although a singlelight guide68 is shown inFIGS. 1B and 1C, it will be appreciated that a plurality of light guides (not shown) may be provided in a common lumen or separate lumens (also not shown) within thecatheter12. The light guide(s)68 may include a plurality of optical fibers, e.g., formed from acrylic and the like, that may extend to theproximal end14 of thecatheter12. As shown inFIG. 1A, a source of light70 may be coupled to the light guide(s)68, e.g., via thehandle30, for delivering light through the light guide(s)68 and into theballoon50.
• Turning toFIGS. 33A-33C, a method is shown for constructing a light source for an imaging catheter, such as those described elsewhere herein. In this embodiment, light may be transmitted to the distal tip of the catheter using afiber optic element33b(or optionally a plurality of fiber optic elements, not shown). A light emitting diode (LED)33amay be coupled to the proximal end of thefiber optic element33ato provide a light source. In order to optimize the amount of light introduced into thefiber optic element33b, thefiber optic element33bmay be placed as close to theLED33aas possible, which may be a custom LED or a modified LED. Most LEDs include a molded lens element to focus light emitted from the diode and direct it forward, as shown inFIG. 33A. Such a lens may be modified by drilling ahole33dtherethrough down to or near to theactual diode33c, as shown inFIG. 33B. The fiber optic element(s)33bmay then be inserted into thehole33d, as shown inFIG. 33C. The fiber optic element(s)33bmay be bonded, fused, or otherwise fixed in thehole33dto prevent subsequent separation from the lens. In addition to maximizing light that enters the fiber optic element(s)33bwithin its acceptance angle, this construction may simplify coupling the fiber optic element(s)33bto thediode33cand/or otherwise facilitate the manufacturing process.
• Adevice72 may be coupled or otherwise provided at theproximal end14 of theapparatus10 for acquiring and/or capturing images obtained by theoptical imaging assembly62. For example, one or more lenses (not shown) may be coupled to thefiber bundle64 for focusing and/or resolving light passing through thefiber bundle64, e.g., to pass the image to thedevice72. Thedevice72 may include a CCD, CMOS, and/or other device, known to those skilled in the art, e.g., to digitize or otherwise convent the light images from thefiber bundle64 into electrical signals that may be transferred to a processor and/or display (not shown).
• For example, as shown inFIG. 26, acomputer82 may be coupled to the device72 (not shown, seeFIG. 1A), e.g., by acable84. Alternatively, instead of thecomputer82, other display or capture devices may be coupled to thedevice72, such as a laptop computer, handheld or PDA device, a computer terminal, a LCD display, standard video monitor, and the like (not shown), to display and/or store the images acquired from thefiber bundle64. Optionally, the computer82 (or other capture device) may provide electrical power to thedevice72,light source70, and/or other components of theapparatus10.
• For a cable connection between thedevice72 and thecomputer82, various protocols may be used, such as USB, Firewire, standard video signal protocols, and the like. Alternatively, thecomputer82 may be coupled to thedevice72 via a wireless connection, for example, including one or more transmitters and/or receiving using radio frequency signals, Bluetooth, infrared links, and the like.
• In addition, thecomputer82 may run software modules to enable capture, viewing, and/or manipulation of images obtained by theoptical imaging assembly62. Thecable84, the handle30 (not shown, seeFIG. 1A), or other component of theapparatus10 may include interface features86, such as buttons, toggles, scroll bars, dials, and the like, to facilitate interfacing with software running on thecomputer82. Functions that may be performed using theinterface86 may include launching image acquisition software on thecomputer82, initiating or terminating image capture, initiating still frame capture, reviewing or displaying captured images, etc. Thehandle30 or other component of theapparatus10 may also contain feedback features, e.g., one or more LEDs or LCDs, to provide feedback from software on thecomputer82, e.g., related to the status of connection(s) between thecomputer82 and theapparatus10, the power status of theapparatus10, the function of theapparatus10, and the like.
• Optionally, theapparatus10 may include additional data acquisition features, such as a microphone (not shown), e.g., allowing procedure notes to be dictated during an imaging procedure or allowing theapparatus10 and/orcomputer10 to be controlled by voice commands. In addition or alternatively, drivers and/or software may be stored on a memory chip (not shown) in theapparatus10 that may be uploaded to thecomputer82 when connected to theapparatus10. When a complex interface is used to connect theapparatus10 to thecomputer82 or other display device, theapparatus10 and/or thecomputer82 may be capable of disabling the complex interface and enable simple video output.
• Turning toFIGS. 6-10, another preferred embodiment of anapparatus410 is shown for visualizing and/or cannulating a body lumen. Similar to the previous embodiments, theapparatus410 generally includes acatheter412, aballoon450 carried by thecatheter412, and animaging assembly462 for imaging through theballoon450.
• Also, similar to the previous embodiments, thecatheter412 may be an elongate tubular body including aproximal end414, adistal end416, and a centrallongitudinal axis418 extending therebetween. Thecatheter412 may be substantially flexible, semi-rigid, and/or rigid along its length, and may be formed from a variety of materials, including plastic, metal, and/or composite materials. Thecatheter412 may have a diameter between about five and ten French (1.67-3.33 mm), and preferably between about six and eight French (2.00-2.67 mm).
• Thecatheter412 may include one or more lumens420 also extending between the proximal anddistal ends414,416, e.g., acannulation lumen420a, aninflation lumen420b, and one ormore lumens420c-ffor theimaging assembly462 and/or one or more pullwires orother steering elements422. In addition, thecatheter412 may include a handle (not shown) and/or other components, e.g., sources of fluid, a light source, an image capture device, and the like (also not shown) on theproximal end414, similar to the other embodiments described herein.
• Preferably, thecatheter412 includes multiple extrusions that are attached to one another to provide a desired length. For example, thecatheter412 may include aproximal portion412ahaving a first cross-section, shown inFIGS. 8A and 8B, and adistal portion412bhaving a second cross-section, shown inFIG. 8C. Theproximal portion412amay have a length between about nine and thirty six inches (22-90 cm), and preferably between about eighteen and twenty eight inches (45-70 cm).
• Theproximal portion412apreferably includes three lumens, acannulation lumen420a, aninflation lumen420b, and anaccessories lumen420c. The cannulation lumen420amay provide a path for a guidewire or other instrument, fluid, and the like to pass between the proximal anddistal ends414,416 of thecatheter412. Optionally, atube424, e.g., made from polyamide and the like, may be provided within thecannulation lumen420a, e.g., to reinforce thecannulation lumen420aand/orcatheter412. Theinflation lumen420bmay communicate with an interior460 of theballoon450, similar to the previous embodiments, for delivering substantially transparent inflation media into theballoon450. The accessories lumen420cmay carry a plurality of components, e.g., an optical imaging (fiber optic)bundle464, pull-wire422, and/or a set of light guides468, similar to the previous embodiments described above.
• With reference toFIGS. 7A and 8C, thedistal portion412bmay have a length between about 25.4-101.6 millimeters (mm), and preferably between about 50.8-76.2 millimeters (mm). Thedistal portion412bmay be substantially permanently attached to theproximal portion412a, e.g., using a lap or butt joint, and/or an adhesive, interference fit, heating, and/or sonic welding. Thedistal portion412bmay include continuations of thecannulation lumen420aandinflation lumen420bfrom theproximal portion412a. In addition, thedistal portion412bmay include alight guide lumen420d, a fiber optic lumen420e, and apullwire lumen420fthat may communicate with the accessories lumen420cwhen the proximal anddistal portions412a,412bare attached to one another.
• Preferably, the fiber optic lumen420eis located as far away from thecannulation lumen420aas possible in order to maximize a field of view of thefiber bundle464 received therein. For example, as shown inFIG. 8C, thedistal portion412bmay include a ridge421 extending axially along an outer surface of thedistal portion412b, thereby maximizing a distance that the fiber optic lumen420emay be disposed away from thecannulation lumen420a. When thefiber bundle464 is inserted into thecatheter412, thefiber bundle464 may be received in the fiber optic lumen420ein thedistal portion412b, and in the accessories lumen420cin theproximal portion412a. Thefiber bundle464 may be secured at one or more locations within thelumens420e,420c, e.g., using an adhesive and the like. Thus, the location of thefiber bundle464 may be fixed in thedistal portion412bto stabilize its field of view relative to thecatheter412.
• Thepullwire lumen420fmay also be located as far away from thecentral axis418, e.g., due to another ridge extending the outer surface. This arrangement may maximize a bending force applied to thecatheter412 when thepullwire422 is pulled proximally.
• Turning to FIGS.7B and9A-9C, the set of light guides468 may be received in the accessories lumen420cin theproximal portion412aand in thelight guide lumen420din thedistal portion412b. The set of light guides468 may include between about one and twenty five, and preferably between about four and ten, elongate light guides. Each of the light guides468 may be formed from a substantially transparent acrylic fiber or other light transmitting material, e.g., having a diameter between about twenty five micrometers and one millimeter (25 μm-1 μm), and preferable between about two hundred fifty and five hundred micrometers (250-500 μm).
• At theproximal end414 of thecatheter412, the light guides468 may be substantially cylindrical, while towards thedistal end416 of thecatheter412, the light guides468 may be tapered and/or flattened. For example, the light guides468 may taper within a few inches of theproximal end414 of thecatheter412, preferably reducing an overall cross-section of the light guides468 by as much as fifty percent (50%). The light guides468 may be disposed loosely within the accessories lumen420cof theproximal portion412a.
• The enlarged size of the light guides468 at theproximal end414 of thecatheter412 may facilitate connecting the light guides468 to a light source (not shown), as will be appreciated by those skilled in the art. Optionally, exposed lengths (not shown) of the light guides468 beyond theproximal end414 of thecatheter412 may be further enlarged to facilitate such connections. For example, if the light guides468 are acrylic fibers, heat may be applied, e.g., up to one hundred seventy degrees Fahrenheit (170° F.), to cause the light guides468 to shorten. The acrylic material may increase in diameter as it shortens, thereby increasing the diameter of the light guides468 by as much as three times as they shorten. This may allow the light guides468 to be columnated and connected to a light source without requiring a lens (not shown).
• As the light guides468 transition from theproximal portion412ato thedistal portion412b, they may be linearly aligned and/or secured to each other, e.g., using an epoxy or other adhesive, and/or by reflowing the fiber material, such that surfaces of adjacent fibers are bonded at adjacent contact points. To align the light guides468 in a desired orientation within thedistal portion412b, the light guides468 may be received in an axial ridge or slot423 within thedistal portion412b, as shown inFIG. 8C.
• The bonded array of light guides468 may provide a hinge, i.e., biasing thedistal portion412bof thecatheter412 to bend in a predetermined direction. Specifically, the light guides468 may provide a higher bending moment along a bond axis “x” (shown inFIG. 9C), while exhibiting a much lower bending moment along an axis orthogonal to the bond axis “x.” As thepullwire422 is pulled proximally, the force may be transferred to thedistal portion412bof thecatheter412. Because of the asymmetric bending moments created by the light guides468, thedistal portion412bof thecatheter412 may bend in one plane orthogonal to the bond axis “x,” i.e., towards thepullwire422, while resisting bending along the bond axis “x.” This may cause thecatheter412 to curve from a location where the pullwire422 transitions from being located at the center of the catheter412 (e.g., as shown inFIG. 8A) to a location on thedistal end416 where thepull wire422 is fixed (e.g., as shown inFIG. 8C).
• Turning toFIGS. 10-11B, abundle464 of optical fibers may be provided, similar to the embodiments described above. Preferably, alens466 is coupled to thefiber bundle464, e.g., a GRIN or self-oc lens, as described above. For example, as shown inFIGS. 11A and 11B, asleeve467, e.g., shrink wrap and the like, may be provided that may be secured around thelens466 and theoptical imaging bundle464. Optionally, a fluid or other material (not shown) may be provided between thelens466 and theoptical imaging bundle464 to minimize losses and/or reflection at the transition, as is known to those skilled in the art.
• Turning toFIG. 10 with continued reference toFIG. 6, atubular extension430 may extend from thedistal end416 of thecatheter412. Thetubular extension430 may include alumen432 extending between proximal anddistal ends434,436 of thetubular extension430. Preferably, thetubular extension430 has a substantially smaller diameter or other cross-section than thedistal end416 of thecatheter412.
• Theproximal end434 of thetubular extension430 may be attached to thedistal end416 of thecatheter412 such that it is coextensive with thecannulation lumen420a. Thus, an instrument or fluid introduced through thecannulation lumen420amay pass freely through thelumen432 of thetubular extension430. In addition, attaching thetubular extension430 eccentrically to thecatheter412 opposite theoptical imaging bundle464 may minimize the extent that thetubular extension430 obstructs the field of view of theoptical imaging bundle464.
• In one embodiment, theproximal end434 of thetubular extension430 may be at least partially received in thecannulation lumen420aor in a recess (not shown) concentric with thecannulation lumen420a. Alternatively, theproximal end434 of thetubular extension430 may be butted against thedistal end416 of thecatheter412. In addition or alternatively, the tubular extension4430 may be bonded to thecatheter412, e.g., using an adhesive, heating, sonic welding, and the like.
• Theballoon450 may include aproximal end452 attached to thedistal end416 of thecatheter412 and adistal end456 attached to the distal end of thetubular extension430. Theproximal end452 of theballoon450 may be secured to the outer surface of thecatheter412, e.g., using an adhesive, heating, an interference fit, an outer collar (not shown), and the like, similar to the other embodiments described herein.
• Turning toFIG. 14, thedistal end456 of theballoon450 may be attached to thedistal end436 of thetubular extension430 such that theballoon450 at least partially inverts on itself. This may facilitate close contact between theballoon450 and a tissue surface being viewed (not shown), which may reduce optical distortion and/or facilitate clearing fluid from between theballoon450 and the contacted tissue surface. In addition, this arrangement may prevent thedistal end436 of thetubular extension430 from extending substantially beyond thedistal surface454 of theballoon450.
• Similar to the previous embodiments, theballoon450 may be expandable from a contracted condition, as shown inFIG. 12A, to an enlarged condition, as shown inFIGS. 6 and 12B-12D. In the enlarged condition, theballoon450 may define a substantially flatdistal surface454 that may facilitate imaging tissue structures beyond theballoon450 with theoptical imaging bundle464. Optionally, theballoon450 may include a reflective coating (not shown) on an inside surface thereof, e.g., the proximal surface(s) opposite thedistal surface454, e.g., to concentrate light towards thedistal surface454 that may otherwise reflect or pass proximally through theballoon450.
• Turning toFIGS. 12A-13D, a method is shown for cannulating a body lumen communicating with a body cavity, e.g., acoronary sinus ostium90 extending from aright atrium92. Although theapparatus410 shown is similar to that shown inFIGS. 6-10, other embodiments described herein may be used to complete similar methods. Initially, as shown inFIG. 12A, theapparatus410 may be provided with theballoon450 in the contracted condition. If theballoon450 is formed from noncompliant and/or inflexible material, theballoon450 may be folded, twisted, or otherwise compressed into the contracted condition. With the balloon collapsed, the fiberoptic imaging bundle464 may provide an unfocused image, as shown inFIG. 13A.
• Thedistal end416 of theapparatus410 may be introduced into a patient's body using conventional methods used for delivering catheters or other instruments. For example, theapparatus410 may be introduced percutaneously into the patient's vasculature from a peripheral vein, such as the femoral vein. Theapparatus410 may be advanced endoluminally, e.g., into the vena cava (not shown) and into theright atrium92 of the heart. Optionally, theapparatus410 may be carried within a sheath, catheter, or other delivery device (not shown) that may protect theballoon450 or otherwise facilitate advancing theapparatus410 through the patient's vasculature.
• Once located within theright atrium92, theballoon450 may be expanded, as shown inFIGS. 6 and 12B (e.g., after deploying at least thedistal end416 from any delivery device). Theapparatus410 may then be manipulated to place thedistal surface454 of theballoon450 into contact with thewall94 of the heart within theright atrium92, as shown inFIG. 12B. Optionally, this manipulation may involve steering thedistal end416 of theapparatus450, e.g., using one or more pullwires or other steering mechanisms actuated from the proximal end (not shown) of theapparatus410.
• In addition or alternatively, other imaging systems may be used to monitor theapparatus410 to facilitate accessing thecoronary sinus90. For example, external imaging systems, such as fluoroscopy, ultrasound, magnetic resonance imaging (MRI), and the like, may provide feedback as to the location and/or relative position of thedistal end416 of theapparatus412. Thedistal end416 may include markers, e.g., radiopaque bands and the like (not shown), that may facilitate such imaging. External imaging may ensure that theapparatus410 is generally oriented towards thecoronary sinus ostium90 before optical images are acquired and theapparatus410 is manipulated more precisely.
• With thedistal surface454 ofballoon450 placed against thewall94 of the heart, thefiber bundle464 may be activated to image thewall94. Sufficient distal force may be applied to theapparatus410 to squeeze blood or other fluid from between thedistal surface454 and thewall94, thereby clearing the field and facilitating imaging thewall94. Optionally, a substantially transparent fluid, e.g., saline, may be delivered through thecatheter412 and thetubular extension430 to further direct blood or other fluid away from thedistal surface454 of theballoon450 or otherwise clear the field of view of thefiber bundle464.
• Using thefiber bundle464 to image thewall94, theapparatus410 may be moved along thewall94 until a target structure is within the field of view. For example, as shown in13B, thecoronary sinus ostium90 may be seen entering the field of view, as theballoon450 approaches thecoronary sinus ostium90, as shown inFIG. 12B. Theapparatus410 may be moved further, as shown inFIG. 12C, until thecoronary sinus ostium90 is centered in the field of view, as shown inFIG. 13C. Preferably, the center of the field of view corresponds to thecentral axis418 of theapparatus410, e.g., aligning thetubular extension430 with thecoronary sinus ostium90.
• Once thecoronary sinus ostium90 is aligned with the tubular extension, theballoon450 may be partially deflated, as shown inFIG. 12D, and thetubular extension430 may be advanced at least partially into thecoronary sinus90. Thus, thetubular extension430 may stabilize theapparatus410 relative to thecoronary sinus90. One or more instruments, e.g., a guidewire (not shown), may be advanced into thecoronary sinus90 to access one or more coronary veins (also not shown) via thecoronary sinus90. Alternatively, theballoon450 may be fully deflated, and thetubular extension430 may be advanced into thecoronary sinus90 to guide thedistal end416 of theapparatus410 into thecoronary sinus90 and/or into the coronary veins.
• In one embodiment, a guidewire may provide a rail over which other instruments may be advanced into the coronary veins. For example, before or after the guidewire has been placed within a target coronary vein, theapparatus410 may be removed from theright atrium92 and/or completely from the patient's body. A catheter or sheath (not shown) may be advanced over the guidewire to access the coronary vein and/or to perform a procedure there. For example, with the catheter or sheath placed within the target coronary vein, the guidewire may be removed, and an electrical lead, e.g., a pacing lead for a pacemaker (also not shown), may be advanced into the coronary vein for implantation.
• In one embodiment, an expandable sheath (not shown) may be delivered via thetubular extension430 into the coronary veins, e.g., to deliver a pacing lead. Exemplary sheath apparatus and methods are disclosed in co-pending application Ser. No. 10/423,321, filed Apr. 24, 2003, the disclosure of which is expressly incorporated by reference herein. In another embodiment, theapparatus410 may be used to deliver fluids or other materials into thecoronary sinus90. For example, a radiopaque fluid may be retro-perfused into thecoronary sinus90, e.g., for obtaining a venogram of one or more coronary veins within the heart.
• Turning toFIG. 15, yet another embodiment of anapparatus510 is shown for visualizing and/or cannulating a body lumen, e.g., acoronary sinus ostium90, similar to the previous embodiment. Similar to the embodiment shown inFIGS. 6-10, theapparatus510 generally includes acatheter512, aballoon550 carried by thecatheter512, and animaging assembly562 for imaging through theballoon550. Thecatheter512 may be an elongate tubular body including a proximal end (not shown), adistal end516, and a centrallongitudinal axis518 extending therebetween.
• Thecatheter512 may include one or more lumens520 also extending between the proximal anddistal ends514,516, e.g., acannulation lumen520a, an inflation lumen (not shown), and one or more lumens (also not shown) for theimaging assembly562 and/or one or more pullwires or other steering elements (also not shown). Atubular extension530 may extend from thedistal end516 of thecatheter512, including alumen532 extending between proximal anddistal ends534,536 of thetubular extension430 that preferably communicates with thecannulation lumen520a.
• Similar to the previous embodiments, theballoon550 may be expandable from a contracted condition (not shown) to an enlarged condition, shown inFIG. 15. In the enlarged condition, theballoon550 may define a substantially flatdistal surface554 that may facilitate imaging tissue structures beyond theballoon550 with theimaging assembly562.
• Unlike the previous embodiment, at least part of theimaging assembly562 may be provided on anarm568 that is extendable from thedistal end516 of thecatheter512. For example, a fiberoptic imaging bundle564 may be carried by thearm568, while one or more light guides (not shown) may be provided on thedistal end516 of thecatheter512, similar to theapparatus410 shown inFIGS. 6-10. Alternatively, one or more light guides (not shown) may be carried by thearm568, in addition or instead of thefiber bundle564.
• A lens and/orprism566 may also be carried by thearm568 for focusing and/or redirecting the field of view of thefiber bundle564. Preferably, a lens andprism566 may be provided for centering the field of view towards a location where thecentral axis518 intersects thedistal surface554 of theballoon550. In addition or alternatively, thearm568 may be bent to orient thefiber bundle564 in a desired direction.
• Thearm568 may be movable from a retracted profile (not shown), wherein thearm568 lies close to or against thedistal end516 of thecatheter512, and an extended profile, shown inFIG. 15, wherein thearm568 extends laterally away from thedistal end516 of thecatheter512. In one embodiment, thearm568 may be biased to the extended profile, and may be restrained in the retracted profile, e.g., by theballoon550 when theballoon550 is deflated to the contracted condition. Alternatively, thearm568 may be movable freely relative to thecatheter512, and a tether (not shown) may be connected to thearm568 that is also connected to theballoon550. Thus, as theballoon550 expands, the tether may pull thearm568 radially outwardly to the extended profile. In yet another alternative, thearm568 may be extended and/or retracted using an actuator (not shown) operable from the proximal end of theapparatus510.
• Theapparatus510 may be used in methods similar to theapparatus410 shown inFIGS. 6-10. One advantage of theapparatus510 is that it may maximize the field of view of thefiber bundle564, as compared to theapparatus410. For example, as shown inFIG. 16A, the apparatus410 (shown inFIGS. 6-10) may include an fiberoptic imaging bundle464 that is carried by thecatheter412 opposite atubular extension430. Because thetubular extension430 extends distally into the field of view “F” of thefiber bundle464, a blind spot BS₂is created. Because thefiber bundle464 is disposed as far away as possible from thetubular segment430 on thecatheter410, the blind spot BS₁is minimized compared to moving the fiber bundle and tubular extension closer to one another (not shown), as will be appreciated by those skilled in the art.
• Turning toFIG. 16B, a field of view “F” of theapparatus510 ofFIG. 15 is shown, which has a similar diameter compared to theapparatus410, assuming comparablysized fiber bundles464,564. Because thefiber bundle564 is carried by the arm568 (seeFIG. 15), it is offset radially away from thetubular extension530, thereby reducing a blind spot BS₂as compared to the blind spot BS₁shown inFIG. 16A. Thus, the arrangement of thefiber bundle564 of theapparatus510 ofFIG. 15 may maximize the field of view, thereby reducing the risk of tissue structures passing through the blind spot undetected.
• Turning toFIGS. 17A-17F, another embodiment of anapparatus610 is shown that includes acatheter612, aballoon650 carried by thecatheter612, and an imaging assembly662 for imaging through theballoon650. Theapparatus610 differs from theprevious apparatus510 shown inFIG. 15, including a pair of fiber optic imaging bundles664 carried byarms668. Thearms668 may be extendable from a retracted profile, e.g., as shown inFIG. 17A to an extended profile, as shown inFIGS. 17C-17F.
• In addition, theballoon650 may be formed from an elastomeric material, such as silicone, latex, isoprene, and chronoprene, such that theballoon650 may expand outwardly in proportion to the amount of fluid delivered into an interior660 of theballoon650. Preferably, theballoon650 is attached to atubular extension630 extending from thedistal end616 of thecatheter612 such that, as theballoon650 expands, adistal surface654 of theballoon650 may become substantially flat and/or at least partially evert, as shown inFIGS. 17E and 17F. This expanded configuration may facilitate increased contact between thedistal surface654 and a tissue structure (not shown) to be imaged.
• As theballoon650 expands, it may allow thearms668 to expand radially outwardly to the extended profile. In addition, thearms668 may be bent such that thefiber bundle664 is oriented substantially distally, as shown inFIGS. 17B-17F. One or more light guides666 may be provided on thedistal end616 of thecatheter612, similar to the previous embodiments for providing light to illuminate thedistal surface654 of theballoon650 and beyond. Optionally, one ormore electrodes617 may be provided on thedistal end616 of the catheter, e.g., for measuring electrical potential and/or to serve as radiopaque markers to facilitate imaging theapparatus610.
• Theapparatus610 may be delivered into a body cavity, e.g., a right atrium, similar to the previous embodiments for imaging a body lumen, e.g., a coronary sinus ostium not shown). The pair offiber bundles664 may increase a field of view of theapparatus610, possibly eliminating any blind spots created by thetubular extension630, as compared to theapparatus510 described above and including a single offsetfiber bundle564.
• Turning toFIGS. 18A and 18B, an alternative embodiment of anapparatus810 is shown that includes acatheter812, aballoon850 carried on adistal end516 of thecatheter812, and animaging assembly862 for imaging through theballoon850. Theballoon850 may be expandable between contracted and enlarged conditions, similar to other embodiments described elsewhere herein. Theapparatus810 may include one or more additional or different components or features (not shown) described elsewhere herein, similar to the other embodiments.
• In addition, theapparatus810 may include an elongatetubular member830 extending from a proximal end (not shown) of thecatheter812 to thedistal end816, and through an interior860 of theballoon850. Thetubular member830 may include a lumen832 extending therethrough through which an instrument, e.g., aguidewire80, and/or a fluid (not shown) may be delivered to a location distally beyond theballoon850. Thetubular member830 may be substantially flexible, but is preferably semi-rigid or substantially rigid.
• Theapparatus810 may be used to deliver one or more instruments or fluids into a body lumen, similar to the other embodiments described herein. In one embodiment, thetubular member830 is fixed relative to thecatheter512. In another embodiment, similar to that described below, thetubular member830 may be slidable axially, i.e., distally and/or proximally, relative to thecatheter512 for changing a shape of theballoon850 during a procedure.
• Turning toFIGS. 19A and 19B, another embodiment of anapparatus710 for cannulating a body lumen, such as acoronary sinus ostium90, is shown. Similar to the previous embodiments, theapparatus710 may include acatheter712, aballoon750 carried by thecatheter712, and an imaging assembly (not shown for simplicity) for imaging through theballoon750.
• In addition, theapparatus710 may include anelongate cannulation member730 that is slidably received in alumen720aof thecatheter712. Thecannulation member730 may be an elongate tubular body, including a lumen832 extending between a proximal end (not shown) and a distal end836 of thecannulation member730. Thecannulation member730 may be substantially flexible, semi-rigid, and/or rigid, similar to the catheters described above.
• Theballoon750 may be expandable between a contracted condition (not shown), and an enlarged condition, shown inFIGS. 19A and 19B. In the enlarged condition, theballoon750 may assume a frustoconical shape. In addition, theballoon750 may include a convexdistal surface754 or a substantially flat distal surface (not shown) in the enlarged condition. Theballoon750 may include achannel section756 that may be attached to thecannulation member730, e.g., adjacent itsdistal end736. Thechannel section756 may at least partially evert into an interior760 of theballoon750, as shown inFIG. 19A, and/or may extend beyond thedistal surface754 of theballoon750, depending upon the axial position of thecannulation member730.
• During use, thecannulation member730 may be provided initially retracted such that thechannel section756 of theballoon750 everts into theinterior760 of theballoon750, as shown inFIG. 19A. With theballoon750 collapsed in the contracted condition, theapparatus710 may be introduced into a patient's body, e.g., until the distal end716 is located within aright atrium92 of the patient's heart, similar to the previous embodiments. Theballoon750 may be expanded, e.g., by delivering a substantially transparent fluid into the interior760 until theballoon750 assumes the enlarged condition, as shown inFIG. 19A.
• Thedistal surface754 of theballoon750 may be placed against thewall94 of the heart, and manipulated while imaging through thedistal surface754 with the imaging assembly. Preferably, the distal end836 of thecannulation member730 may remain flush or proximal to thedistal surface754, thereby allowing thewall94 to be imaged through theballoon750. A more proximal position may prevent thecannulation member730 from interfering substantially with a field of view of the imaging assembly, which may facilitate aligning theapparatus710 with thecoronary sinus ostium90.
• When theapparatus710 is aligned with thecoronary sinus ostium90, as shown inFIG. 19B, thecannulation member730 may be advanced distally into thecoronary sinus90. Optionally, theballoon750 may be at least partially deflated as or after thecannulation member730 is advanced, thereby allowing the distal end716 of thecatheter712 to be inserted into thecoronary sinus90 as well.
• An instrument, e.g., a guidewire, catheter, and the like (not shown), may be delivered through thelumen732 of thecannulation member730, e.g., to perform a diagnostic and/or therapeutic procedure within a region accessed, e.g., within a coronary vein (not shown). Once the procedure(s) is(are) completed, theapparatus710 may be removed from the patient's body.
• Turning toFIGS. 20A-20C, still another embodiment of anapparatus910 is shown for visualizing and/or cannulating a body lumen (not shown). Similarly to the previous embodiments, theapparatus910 may include acatheter912, aballoon950 carried by adistal end916 of thecatheter912, and animaging assembly962, similar to the previous embodiments.
• Unlike the previous embodiments, theballoon950 may not include a channel extending therethrough, and instead includes an interior960 that is substantially enclosed. A lumen, e.g., aninflation lumen920b, may extend from a proximal end (not shown) of thecatheter912 to thedistal end916 that communicates with theinterior960 of theballoon950. In addition, thecatheter912 may include acannulation lumen920athat may extend along an outer surface of thecatheter912 through which an instrument, e.g., guidewire80, and/or a fluid may be delivered to thedistal end916 of thecatheter912 outside theballoon950.
• Theapparatus910 may also include anelongate member930 that is slidable within theinflation lumen920bor optionally through another lumen (not shown) that communicates with theinterior960 of theballoon950. Preferably, theelongate member930 includes a substantially bluntdistal end936 that may be advanced into theinterior960 of theballoon950. For example, theelongate member930 may be inserted into theinflation lumen920bfrom the proximal end of thecatheter912, or theelongate member930 may not be removable from thecatheter912, and, instead, may be slidable in a limited range within theinflation lumen920b.
• During use, theapparatus910 may be advanced into a patient's body, e.g., into a right atrium of a heart or other body cavity (not shown) with theballoon950 collapsed, similar to the previous embodiments. Within the body cavity, theballoon950 may be expanded, as shown inFIG. 20A, such that theballoon950 defines a substantially flatdistal surface954. Thedistal surface954 may be placed against a wall of the body cavity, and manipulated, e.g., steered and/or otherwise moved, until a target body lumen, e.g., a coronary sinus ostium (not shown) enters the field of view of a fiberoptic imaging bundle964 of theimaging assembly962, similar to the previous embodiments.
• Once the target body lumen is located and theapparatus910 is aligned with the body lumen, theelongate member930 may be advanced through theinflation lumen920band into theinterior960 of theballoon950. Thedistal end936 of theelongate member930 may contact thedistal surface954 of theballoon950, whereupon, further distal movement of theelongate member930 may cause theballoon950 to change shape, as shown inFIGS. 20B and 20C. Because of the substantially blunt shape of thedistal end936 of the elongate member, theballoon950 may be changed without substantial risk of puncturing or otherwise damaging theballoon950.
• For example, theelongate member930 may be advanced to elongate theballoon950 and/or reduce a diameter or other cross-section of theballoon950. This may at least partially introduce theballoon950 into the body lumen, e.g., the coronary sinus, thereby stabilizing theapparatus910 relative to the body lumen. Alternatively, theelongate member930 may reduce a cross-section of theballoon950, thereby allowing an instrument, e.g., aguidewire80, to be advanced through thecannulation lumen920aand past theballoon950 without substantial risk of puncturing or otherwise damaging theballoon950. Theguidewire80 may be advanced into the body lumen, whereby additional instruments (not shown) may be advanced over theguidewire80 into the body lumen, as described above.
• Alternatively, as shown inFIGS. 21A-21C, anapparatus1010 may be provided that includes aballoon1050 carried by acatheter1012, and animaging assembly1062 for imaging through theballoon1050. Similar to the previous embodiments, substantially transparent fluid, e.g., saline, may be introduced into theballoon1050 to expand theballoon1050 and allow adistal surface1054 to be placed into contact with tissue structures, e.g., a wall of a heart, similar to the previous embodiments.
• An elongate member, e.g., aguidewire1030, may be inserted through aninflation lumen1020bof thecatheter912 into the interior of theballoon1050, e.g., after theballoon950 has been inflated and/or used to identify and/or locate a body lumen (not shown), similar to the previous embodiment. As shown inFIG. 21B, theguidewire1030 may be advanced until adistal end1036 of theguidewire1030 punctures theballoon1050 and passes therethrough into the target body lumen. Optionally, the distal end1032 of theguidewire1030 may be sharpened or otherwise adapted to facilitate puncturing theballoon1050.
• As the inflation fluid escapes through the puncture created in theballoon1050, theballoon1050 may collapse, as shown inFIG. 21C. Theguidewire1030 may be advanced into the body lumen, and one or more instruments (not shown) may be advanced over the guidewire, e.g., after removing theapparatus1010, as described above.
• In a further alternative, shown inFIGS. 22A-22C, anapparatus1110 may be provided that includes acatheter1112, aballoon1150 carried on adistal end1116 of thecatheter1112, and animaging assembly1162 for imaging through theballoon1150. Similar to the previous embodiment, an inflation lumen120bextends through thecatheter1112 to communicate with an interior1160 of theballoon1150. Unlike the previous embodiment, acannulation lumen1120aextends along an outer surface of thecatheter1112.
• During use, as shown inFIG. 22A, theapparatus1110 may be introduced into a body cavity (not shown), whereupon theballoon1150 may be expanded and contacted with a wall of the body cavity for imaging tissue structures therethrough. When theapparatus1110 is aligned with a body lumen extending from the body cavity, theballoon1150 may be at least partially deflated, as shown inFIGS. 22B and 22C. Once thecannulation lumen1120ais not obstructed by theballoon1150, aguidewire80 or other instrument may be advanced through thecannulation lumen1120apast theballoon1150, and preferably into the body lumen, similar to the procedures described above.
• Turning toFIGS. 23A-25B and39, yet another embodiment of anapparatus1210 is shown for visualizing and/or cannulating a body lumen, e.g., a coronary sinus ostium extending from a right atrium of a heart (not shown). Similar to the previous embodiments, theapparatus1210 includes acatheter1212 carrying animaging assembly1262 on itsdistal end1216, which may include a fiberoptic imaging bundle1264 and one or more light guides1268, as described above.
• In addition, theapparatus1210 may include asolid bulb1250 carried on thedistal end1216 of thecatheter1212. Thebulb1250 may be formed from a substantially rigid or semi-rigid material that is substantially transparent, e.g., acrylic, polycarbonate, polymethlymethacrylate (PMMA), and nylon. Thebulb1250 may define an interior1260 that may be filled with substantially transparent fluid, e.g., saline, to facilitate imaging through thebulb1250 using theimaging assembly1262.
• In the embodiment shown inFIGS. 23A and 24A, the fiberoptic imaging bundle1264 and thelight guide1268 may be disposed side-by-side when viewed from the end of thecatheter1212, as best seen inFIG. 24A. In addition, similar to any of the embodiments described herein, theapparatus1210 may include one or more pullwires, e.g., the twopullwires1222 shown, for steering thecatheter1212, as described above.
• Alternatively, as shown inFIGS. 23B and 24B, theapparatus1210′ may include a centrally disposed fiberoptic imaging bundle1264,′ a plurality oflight guides1268′ may be disposed around theimaging bundle1264,′ and one or more pullwires1222.′
• With reference toFIGS. 23A and 24A, during use, theapparatus1210 may be introduced into a body cavity (not shown), and thebulb1250 may be placed against a wall of the body cavity to image the wall through thebulb1250 using theimaging assembly1262. Preferably, sufficient distal force is applied to clear blood or other fluid from between thebulb1250 and the wall of the body cavity. Optionally, an external cannulation lumen (not shown) may be provided on thecatheter1250 for delivering a guidewire or other instrument (not shown) into a body lumen (also not shown) communicating with the body cavity, as described above. The alternative embodiment shown inFIGS. 23B and 24B may be used in a substantially similar manner.
• In another alternative, shown inFIGS. 25A and 25B, anapparatus1210″ may be provided that includes a substantiallytransparent bulb1250″ and animaging assembly1262,″ similar to the previous embodiment. In addition, an occlusion member, e.g., acompliant balloon1230″ may be provided on thecatheter1212″ proximal to thebulb1250.″
• Thecatheter1212″ may include multiple lumens, e.g., an inflation lumen1220b” and aperfusion lumen1220c″ that extend from a proximal end to thedistal end1216″ of thecatheter1212.″ The inflation lumen1220b″ may communicate with an interior1232″ of theocclusion balloon1230″ for inflating and/or deflating theballoon1230.″ Theperfusion lumen1220c″ may communicate with anoutlet port1225″ for delivering fluids from a proximal end of thecatheter1212″ to a location distal to theocclusion balloon1230.″
• During use, theapparatus1210″ may be introduced into a body cavity, e.g., a right atrium of a heart (not shown), similar to the embodiments described above, with theocclusion balloon1230″ collapsed. Thebulb1250″ may be pressed against a wall of the heart in order to image and locate the coronary sinus ostium (not shown), also similar to the previous embodiments. Once the coronary sinus ostium is located, theapparatus1210″ may be inserted into the coronary sinus until theocclusion balloon1230″ is at least partially received in the coronary sinus.
• Theocclusion balloon1230″ may then be inflated to engage the wall of the coronary sinus, preferably substantially sealing the coronary sinus from fluid flow therethrough. Fluid may be delivered through theperfusion lumen1220c″ until it exits theport1225″ and enters the coronary sinus, thereby perfusing the coronary sinus in a retrograde direction. The fluid may include a diagnostic agent, e.g., contrast for performing a venogram or other procedure, and/or a therapeutic agent. Upon completing the procedure, theocclusion balloon1230″ may be deflated, and theapparatus1210″ may be removed from the patient's heart and/or body.
• In another alternative, shown inFIG. 39, thebulb1250 may be elongate, e.g., to preserve an offset between theimaging assembly1262 and a surface to be imaged, e.g., the wall of theheart94, thereby determining the viewable area. The viewable area may be a function of the view angle Φ of theimaging assembly1262 and distance between theimaging assembly1262 and a surface or structure being visualized. In this embodiment, thebulb1250, when placed against a moving surface, such as the wall of theheart94, may move with the movement of the surface, causing theimaging assembly1262 to move correspondingly, thereby creating a substantially stable field of view. Furthermore, thebulb1250 may be adapted to engage or substantially adhere to thesurface94 being imaged, e.g., to minimize relative motion between thebulb1250 and a moving surface being imaged.
• In the heart, for example, a desirable field of view may correspond to a structure of interest that is being imaged. For example, the foramen or fossa ovale (not shown) may be between one and four centimeters in cross-section. Thus, the length of thebulb1250 may be such that, based on the view angle Φ of theimaging assembly1262, the viewable area may be between one and four centimeters in cross-section. Other structures of interest may include the coronary sinus ostium, coronary veins or vein branches, valves within the heart, such as the tricuspid valve, mitral valve, pulmonary valve, aortic valve, thebesian valve, etc., pulmonary arteries, pulmonary veins, atrial appendage, and the like. Likewise, the apparatus may be optimized to view other structures of a given size by adjusting the length of thebulb1250. Furthermore, the length of the bulb1250 (or other stabilization and/or offset elements described elsewhere herein) may be fixed for a given apparatus or may be adjustable such that the viewable area is therefore adjustable. As described above, thebulb1250 may be solid and constructed of a variety of materials, for example, those transparent to a wavelength of light used to image, including visible light, UV, IR and the like.
• Furthermore, with respect to the wavelength or wavelengths of light used to image, the index of refraction (IOR) of the material from which the bulb is constructed may be substantially matched to the medium in which theapparatus1210 is being used. For example, if imaging in or through blood with an appropriate wavelength, the IOR of thebulb1250 may be substantially matched to the IOR of blood for the wavelengths being used to image. Alternatively, if imaging in a saline filled environment, the IOR of the bulb may be substantially matched to saline, for example, by constructing thebulb1250 from silicone. By properly selecting the material and/or properties, distortion may be minimized. Alternatively, as described above, thebulb1250 may define an interior, which may be filled with a fluid (e.g., air, saline, contrast material, and the like) that has an IOR substantially similar to the medium in which imaging is being carried out.
• Furthermore, thebulb1250 may be constructed of a relatively thin transparent material. In this case, the IOR of the bulb material may differ more substantially from the IOR of the fluid in the interior of thebulb1250 and/or the medium in which imaging is being carried out, without greatly distorting the image, rather only creating an offset proportionate to the thickness of the wall of thebulb1250 and the IOR differentials. Furthermore, in addition to visible light, thebulb1250 may be constructed such that other methods of imaging may be used through thebulb1250, for example, ultrasound. In this case, thebulb1250 may allow transmission of ultrasound for imaging, but serve the same purpose of stabilization and offset with respect to a surface being imaged. Again, this may be of particular use in structures such as the heart where constant motion of the wall of the heart may cause unsteady imaging where an imaging apparatus is free floating in a chamber of the heart.
• Alternatively, thebulb1250 may be replaced by atubular extension430 as illustrated inFIG. 40. This tubular extension may serve the same purpose of stabilization and offset between theimaging assembly1262 and a surface being imaged (not shown).
• Alternatively, any number ofextensions1250amay be provided, as for example shown inFIG. 41 so as to minimize obscuration of the viewable area provided by theimaging assembly1262. Additionally, this approach may be useful for providing stabilization and offset from structures which are substantially annular such as the coronary sinus ostium, tri-cuspid valve, mitral valve, and other valve, orifices, and ostia. This may be useful, for example in providing detailed imaging of valve closure as the apparatus may be stabilized in front of a valve, for example the tri-cuspid or mitral valve, and isolated from the motion of the beating heart, such that the mechanics and function of the valve can be studied in detail. In such a case a high temporal resolution of imaging and/or gating may be helpful in the study of such a structure. For example, if studying closure of a valve in the heart, a frame rate in the range of hundreds or thousand per second may allow detailed study of the mechanical closure of the valve. Alternatively, or in addition, image gating may be used to image a particular point in the periodic sequence of valve closure.
• Turning toFIGS. 27A-27D, another embodiment of anapparatus1310 is shown for cannulating a coronary sinus ostium or other body lumen of a patient (not shown). Generally, theapparatus1310 includes acatheter1312, including aproximal end1314, adistal end1316, and alongitudinal axis1318 extending therebetween. In addition, thecatheter1312 may include one or more lumens, e.g., acannulation lumen1320, which may extend along an outer surface of thecatheter1312, as shown, or may be located within the catheter1312 (not shown). In addition, thecatheter1312 may include one or more pullwires or other steering elements (no shown) that may be controlled from ahandle1330, similar to the previous embodiments.
• A plurality ofoxygen sensors1350 may be carried on thedistal end1316 of thecatheter1312. Preferably, theoxygen sensors1350 are disposed on the ends of wires or otherelongate filaments1352 that are biased away from one another, e.g., to provide an annular array of oxygen sensors. Thefilaments1352 may extend through thecatheter1312 from thedistal end1316 to theproximal end1314. Alternatively, theoxygen sensors1350 may be provided on an exterior of a balloon or other expandable member (not shown) carried on thedistal end1316 of thecatheter1312.
• Preferably, as shown inFIG. 27D, eachfilament1352 includes one or moreelectrical leads1354,1356, and one ormore stiffening members1358. Thestiffening members1358 may bias theoxygen sensors1350 to the radial configuration shown. The electrical leads1354,1356 may be coupled to acapture device1360, shown inFIG. 27A, which may include a power source, a controller, memory, or other components (not shown) for operating and/or receiving data from theoxygen sensors1350. Thecapture device1360 may analyze and/or otherwise capture oxygen measurements from theoxygen sensors1350.
• During use, theapparatus1310 may be introduced into a right atrium or other body cavity (not shown), similar to the previous embodiments. Preferably, theoxygen sensors1350 are constrained close to one another during advancement, e.g., to protect theoxygen sensors1350 and/or to minimize a profile of theapparatus1310. For example, theapparatus1310 may be provided within a sheath, catheter, or other delivery device (not shown) that may facilitate advancing theapparatus1310 through the patient's vasculature.
• Once thedistal end1316 is located within the right atrium, theoxygen sensors1350 may be deployed from the delivery device. Because blood flowing from the coronary sinus ostium has less oxygen than blood flowing through the right atrium, theoxygen sensors1350 may be used to locate the coronary sinus ostium. Once the coronary sinus ostium is located, theapparatus1310 may be advanced into the coronary sinus, or a guidewire or other instrument (not shown) may be advanced from theapparatus1310, e.g., from thecannulation lumen1320 into the coronary sinus, similar to the previous embodiments. Thus, the guidewire may provide a rail for advancing other instruments into the coronary sinus and/or into coronary veins accessed therethrough.
• In an alternative embodiment, shown inFIGS. 28A and 28B, anapparatus1410 may be provided that includes acatheter1412 carrying one ormore oxygen sensors1450 and a balloon orother occlusion member1430. In the preferred embodiment shown, asingle oxygen sensor1450 may be provided on the distal end1416 of thecatheter1412, and one or moreelectrical leads1454,1456 may extend from theoxygen sensor1450 through thecatheter1412, e.g., to a capture device (not shown), similar to the previous embodiment. Theballoon1430 may facilitate retrograde perfusion of the coronary sinus, similar to the embodiment shown inFIG. 25A and described above. Instead of using a fiber optic imaging bundle, the oxygen sensor, preferably a solid-state device, may facilitate monitoring perfusion of the coronary sinus or other body lumen.
• Turning toFIGS. 29A-29C, another embodiment of anapparatus1510 is shown that may include acatheter1512, aballoon1550, and an imaging assembly (not shown for simplicity) carried by thecatheter1510, similar to the embodiments described above. In addition, theapparatus1510 may include anelongate member1530 that may be deployed from achannel1552 extending through theballoon1550. Theelongate member1530 may be slidable relative to thecatheter1512, e.g., such that adistal end1536 of theelongate member1530 may be advanced through thechannel1552 and beyond adistal surface1554 of theballoon1550, as shown inFIG. 29B.
• Theapparatus1510 may include a handle and/or one or more controls (not shown), e.g., at a proximal end (also not shown) of thecatheter1512, e.g., for sliding theelongate member1530 relative to thecatheter1512. For example, a tab, bar, or other element (not shown) coupled to theelongate member1530 may be slidable in a slot in a handle for limiting movement of theelongate member1530.
• Theelongate member1530 may facilitate cannulating acoronary sinus ostium90 or other body lumen, and/or may facilitate localizing other morphological features of tissue being imaged, e.g., to maintain a position of thedistal end1516 of thecatheter1512 relatively constant. Thus, theelongate member1530 may act as a stabilization member or a localization member, e.g., allowing theballoon1550 to be deflated, as shown inFIG. 29C, without moving thedistal end1516 of thecatheter1512 laterally away from theostium90 or other morphological feature. In addition or alternatively, theelongate member1530 may facilitate advancing theapparatus1510 into theostium90 or other lumen, e.g., after theballoon1550 has been deflated, also as shown inFIG. 29C.
• Thedistal end1536 of theelongate member1530 may be constructed for a particular purpose, e.g., having a size for cannulating an ostium of a particular size and/or having a substantially atraumatic tip. Optionally, thedistal end1536 may be shapeable and/or steerable, using an internal pullwire or other element, similar to the catheter embodiments described above. For example, theelongate member1530 may include an annealed wire, which may be bent to provide a desired shape to thecatheter1512. Alternatively, theelongate member1530 may be adapted for stabilizing thedistal end1516 of thecatheter1512 using other morphologic features of tissue being imaged.
• For example, as shown inFIG. 30A, thedistal end1536′ may have a cone or wedge shape that may allow thedistal end1536′ to be wedged or otherwise inserted temporarily into a crevasse or depression (not shown), e.g., in a chamber of a heart, such as the trebaculae carne on a wall of a heart. Alternatively, as shown inFIG. 30B, anelongate member1530″ may be provided that includes a bentdistal end1536,″ e.g., having an “S” or other curved shape. In a further alternative, shown inFIG. 30C, anelongate member1530″′ is shown that includes a forkeddistal end1536′″ that may be used to straddle a ridge, such as the eustation ridge in the right atrium (not shown).
• Returning toFIGS. 29A-29C, preferably, theelongate member1530 is movable between a retracted position, such as that shown inFIG. 29A, and a deployed position, as shown inFIG. 29B. The retracted position may allow substantial apposition of thedistal surface1554 of theballoon1550 against a structure being imaged, e.g., awall94 of a heart, e.g., to facilitate imaging the structure, similar to the embodiments described previously. When theelongate member1530 is moved towards the deployed position, as shown inFIG. 29B, thedistal end1536 may interact with the structure of interest.
• For example, as shown inFIG. 29B, thedistal end1536 may at least partially enter thecoronary sinus ostium90 to temporarily localize thedistal end1516 of thecatheter1512 at thecoronary sinus ostium90. During use, theapparatus1510 may be introduced into theright atrium92 of a heart, similar to the previous embodiments, and then theballoon1550 may expanded and pressed against thewall94 of the heart. Thewall94 may be imaged through thedistal surface1554, and thedistal end1512 manipulated until thecoronary sinus ostium90 is aligned with thechannel1552.
• As shown inFIG. 29B, thedistal end1536 of the elongate member1503 may be deployed until at least partially received in thecoronary sinus ostium90, thereby localizing and/or stabilizing thecatheter1512. As shown inFIG. 29C, theballoon1550 may be at least partially deflated, whereupon thedistal end1516 of thecatheter1512 may be inserted into thecoronary sinus ostium90, thereby cannulating theostium90.
• Turning toFIGS. 34-38, another embodiment of anapparatus1510 is shown that may include acatheter1512, aballoon1550, and an imaging assembly (not shown for simplicity) carried by thecatheter1512, similar to the embodiments described above. In one embodiment, theballoon1550 may extend beyond the tip of thecatheter1512, e.g., to form a distal smooth surface that may be placed against the wall of a body lumen, such as the heart. Thedevice1510 may facilitate navigation using its relatively large smooth distal surface.
• For example, when navigating within the heart, the distal tip may not catch or snag on trabeculations, fibers, valves, or other features within the heart. Theballoon1550 may be made of a compliant material or noncompliant material. For example, when theballoon1550 is made of a compliant material, theballoon1550 may easily deform around obstacles that it encounters. Theballoon1550 surface may be coated and/or treated to facilitate movement along surfaces or may be disposed with a tacky surface to facilitate stability. Additionally, the large surface area that is placed against the wall of the heart may improve stability of the catheter once a desired location is achieved.
• Referring toFIGS. 34 and 35, theapparatus1510 may facilitate cannulating an ostium, such as the coronary sinus, pulmonary vein, pulmonary artery, and the like. For example, as shown inFIG. 34, with theballoon1550 expanded, thecatheter1512 may be positioned adjacent thecoronary sinus ostium90, e.g., to allow one or more devices (not shown) to be delivered from thecatheter1512 into theostium90. As shown inFIG. 35, theballoon1550 may facilitate tracking into and/or stabilizing theapparatus1510. For example, theballoon1550 may be at least partially received within the natural taper of theostium90, thereby facilitating engaging and stabilizing thecatheter1512 relative to theostium90. Thus, thecatheter1512 may be stabilized even if theostium90 and surrounding tissue is moving, e.g., due to normal beating of the heart. Thus, it may not be necessary to catch surrounding tissue features (e.g., valves, trabeculations, and the like) to stabilize thecatheter1550.
• However, depending upon the size of theostium90, the fully inflatedballoon1550 may be too large to advance into theostium90, e.g., to a position that substantially stabilizes thecatheter1550 relative to theostium90. If desired, the size of theballoon1550 may be adjusted, e.g., by inflating or deflating theballoon1550, to allow theballoon1550 to attain a stable position sufficiently within theostium90. Alternatively, theballoon1550 may be fully or partially deflated and further advanced into theostium90, as shown inFIG. 36.
• In the inflated or partially inflated state, theballoon1550 may present a substantially atraumatic surface, which may contact the anatomy or other surface against which theballoon1550 is pressed. Because of the atraumatic surface, theballoon1550 may not catch or hang up on features in or extending from the surface, such as valves. Advancing a catheter without such an atraumatic surface may increase the risk of dissection or perforation of the surface when the catheter is pressed or moved along the surface. With further reference toFIG. 36, thecatheter1550 may enter theostium90 at an angle relative to the lumen extending from theostium90, which cannot be fully controlled and/or may be dependent on the patient's anatomy. Because of this unpredictability of the angle of entrance, further advancement of a catheter without the atraumatic surface may risk the distal tip of the catheter digging into the wall of the heart or vessel. The enlarged surface provided by theballoon1550, however, provides an atraumatic interface that may avoid damage to the tissue.
• Various methods for cannulating vessels and/or ostia follow from the previous description. In one method, acatheter apparatus1510 with a distalexpandable member1550 may be advanced into the heart. Theexpandable member1550 may be expanded to present a substantially smooth surface of increased size (as compared to the tip of thecatheter1512 alone), which may also be used to scan the wall of the heart without catching and/or hanging up on anatomical features as described above (e.g., as shown inFIG. 34). Thecatheter1512 may be stabilized against the wall of the heart by pushing the expanded surface of theballoon1550 against the wall. The expanded surface of theballoon1550 may also naturally track at least partially into theostium90 and stabilize thecatheter1512 in the tapered entry leading to theostium90.
• In a body lumen where a natural taper does not exist or is less prominent, theballoon1550 may still stabilize by deforming, e.g., as theballoon1550 at least partially enters theostium90, as shown inFIG. 36. Although balloon catheters are generally known in the art, this method of use differs significantly from current methods. The apparatus and method described herein may include aballoon1550 having a substantially smooth distal surface without protruding members, whereas conventional balloon catheters generally have a tip of the catheter that extends beyond the balloon. Additionally, balloon compliance and/or shape may be optimized to avoid catching or hanging up on anatomical features within the heart. For example, theballoon1550 may be substantially compliant to enhance the atraumatic nature of the enlarged distal surface.
• In addition to improved navigability and stability, the apparatus and methods described herein may facilitate fluoroscopic identification of ostia or other anatomical features. For example,FIG. 37 shows anapparatus1510 being used without perfusing contrast media into the body, whileFIG. 38 shows theapparatus1510 being used to infuse contrast media into the body lumen.
• With additional reference toFIG. 36, theballoon1550 may tend to deform according to the surface against which it is being pressed. In the case of an ostium, a tapered or other deformed shape may induced in theballoon1550 by pressing theballoon1550 at least partially into theostium90. If theballoon1550 is filled with a radiodense contrast material, this deformation may be visible by fluoroscopic imaging and may be used by the operator to determine the shape of the surface against which theballoon1550 is being pushed. As another example, theballoon1550 may be pushed into the atrial septum causing it to deform to conform to the tenting shape of the septum. This may shape may be monitored fluoroscopically to facilitate identification of the atrial septum.
• Furthermore, this device and method may facilitate improved imaging using injected contrast media. As shown inFIG. 38,contrast media91 may be infused through thecatheter1512, leaving the distal end of thecatheter1512 as shown. The large surface area of theballoon1550 may trap contrast between the wall, lumen, or other anatomy and theballoon1550, which may highlights the interface between the balloon and the anatomy, thereby allowing observation of the surface features of the anatomy, e.g., the wall of theheart14. In the case of a venous ostium, where contrast may not naturally flow into the area, the large flat surface of theballoon1550 may enable easy identification of the ostium by infusion of contrast.
• Alternatively and/or in addition, the apparatus previously described herein may also incorporate deflectability, steerability, and/or a pre-shaped element or a combination of these features in order to achieve further improved navigability.
• Although different embodiments have been described herein with particularity as including specific components and/or features, it will be appreciated that each of the embodiments described above may include components and/or features specifically described with respect to individual embodiments. For example, any of the embodiments described above may include one or more of the following: a handle on a proximal end of a catheter, one or more pullwires or other steering elements for steering a catheter and/or a localization/stabilization member, steering controls or actuator, a source of light, a capture device, e.g., including a display, processor for analyzing image data, and/or memory for storing imaging data, sources of fluid, e.g., for delivering inflation media, diagnostic, and/or therapeutic agents, and the like. Thus, different components may be provided on each of the embodiments, depending upon a specific application.
• In addition, each of the apparatus described may be used to perform any of the procedures described herein and should not limited to the specific examples described. For example, any of the apparatus described may be used for imaging, accessing, and/or cannulating a collapsible lumen, such as the colon. Embodiments with channels through balloons or other expandable and/or displacement members may be used to deliver insufflation media, e.g., carbon dioxide, nitrogen, and/or air, into a collapsible lumen to facilitate performing a procedure therein.
• While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and described herein in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but, to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims (26)

1. An apparatus for imaging a body structure within a body cavity, comprising:

a flexible tubular member comprising a proximal end, a distal end sized for introduction into a body cavity, and a central longitudinal axis extending between the proximal and distal ends;

an optical imaging element carried by the distal end of the tubular member for imaging beyond the distal end; and

an extension attached eccentrically to the distal end and extending distally from the distal end for contacting a surface of a body cavity within which the distal end of the tubular member is introduced, the extension having a predetermined length to maintain the optical imaging element away from the surface by the predetermined length, thereby at least partially defining a field of view of the optical imaging element.

2. The apparatus ofclaim 1, further comprising a substantially transparent member comprising a proximal end attached to the distal end of the tubular member and a distal end attached to the extension for substantially isolating the optical imaging element from contact with fluid within the body cavity.

3. The apparatus ofclaim 2, wherein the substantially transparent member comprises an expandable member that is expandable from a contracted condition to an enlarged condition when fluid is introduced through the tubular member into an interior of the expandable member;

4. The apparatus ofclaim 2, wherein the substantially transparent member comprises a substantially rigid bulb.

5. The apparatus ofclaim 2, wherein the substantially transparent member comprises a substantially flat distal surface to facilitate imaging tissue structures beyond the expandable member with the optical imaging element.

6. The apparatus ofclaim 1, wherein the distal end of the tubular member is exposed such that the optical imaging element contacts fluid within a body cavity within which the distal end of the tubular member is introduced.

7. The apparatus ofclaim 1, wherein the optical imaging element is disposed away from the central longitudinal axis to minimize obstruction of a field of view of the optical imaging element by the extension.

8. The apparatus ofclaim 7, wherein the optical imaging element is fixed to the distal end generally opposite the extension.

9. The apparatus ofclaim 1, wherein the extension comprises a tubular extension, and wherein the tubular member comprises a cannulation lumen extending between the proximal and distal ends, the cannulation lumen communicating with the tubular extension for delivering an instrument through the tubular extension beyond the tubular extension.

10. The apparatus ofclaim 1, wherein the optical imaging element comprises a plurality of optical fibers.

11. The apparatus ofclaim 10, wherein the optical imaging element further comprises a lens coupled to the plurality of optical fibers for imaging beyond the extension.

12. The apparatus ofclaim 1, further comprising a light source carried by the distal end of the tubular member for delivering light beyond the extension.

13. A method for imaging structures within a body cavity, comprising:

inserting a distal end of a tubular member into a body cavity, the tubular member comprising an optical imaging element on the distal end and an extension extending distally beyond the distal end and having a predetermined length;

advancing the tubular member until the extension contacts a surface of the body cavity, thereby disposing the optical imaging element away from the surface by a distance corresponding to the predetermined length; and

imaging the surface using the optical imaging element.

14. The method ofclaim 13, further comprising manipulating the tubular member to move the extension along the surface while continuing to image the surface using the optical imaging element.

15. The method ofclaim 13, wherein the body cavity comprises a chamber of a beating heart, and wherein the tubular member is advanced with sufficient force to maintain the extension in substantially continuous contact with the surface while the heart is beating, thereby substantially stabilizing the optical imaging element relative to the surface.

16. The method ofclaim 13, wherein the tubular member comprises a substantially transparent member extending between the distal end and the extension, the method comprising placing a distal surface of the substantially transparent member against the surface to facilitate imaging of the surface using the optical imaging element.

17. The method ofclaim 16, wherein the substantially transparent member comprises an expandable member, the method further comprising expanding the expandable member within the body cavity before placing the distal surface of the expanded expandable member against the surface.

18. The method ofclaim 16, wherein the substantially transparent member is substantially transparent to infrared light, and wherein the optical imaging assembly images using infrared light.

19. The method ofclaim 13, wherein the surface is imaged to identify one or more tissue structures in or extending from the surface.

20. The method ofclaim 19, wherein the one or more tissue structures comprises a coronary sinus ostium.

21. A method for imaging a wall of a body cavity of a patient, comprising:

inserting a distal end of a tubular member into the body cavity, the tubular member comprising a substantially transparent member extending from the distal end;

placing a distal surface of the substantially transparent member against a surface of the body cavity in order to image the surface through the substantially transparent member using an optical imaging element on the distal end; and

applying sufficient force to maintain the distal surface in substantially continuous contact with the surface of the body cavity for substantially stabilizing the optical imaging element relative to the surface.

22. The method ofclaim 21, further comprising manipulating the tubular member to move the substantially transparent member along the surface while imaging the surface through the substantially transparent member.

23. The method ofclaim 21, wherein the distal surface of the substantially transparent member is maintained a predetermined distance from the optical imaging element to maintain the optical imaging element away from the surface being imaged.

24. The method ofclaim 21, wherein the body cavity comprises a chamber within a beating heart and wherein sufficient force is applied to maintain the distal surface in substantially continuous contact with the surface while the heart is beating, thereby substantially stabilizing the optical imaging element relative to the surface.

25. The method ofclaim 21, further comprising the tubular member to align a body lumen extending from the body cavity within a field of view of the optical imaging element, thereby substantially aligning a channel through the substantially transparent member with the body lumen.

26. The method ofclaim 25, further comprising advancing an instrument through the channel into the body lumen after the channel is substantially aligned with the body lumen.

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