Patent Grant
10064540
The present invention relates generally to medical devices used for visualizing and/or manipulating regions of tissue within a body. More particularly, the present invention relates to apparatus and methods for visualizing and/or manipulating tissue regions within a body lumen, e.g., tissue surrounding or adjacent to valves within a heart, which are generally difficult to image because of surrounding opaque bodily fluids such as blood or the tissue of the inter-atrial septum for transseptal procedures.
Conventional devices for visualizing interior regions of a body lumen are known. For example, ultrasound devices have been used to produce images from within a body in vivo. Ultrasound has been used both with and without contrast agents, which typically enhance ultrasound-derived images.
Other conventional methods have utilized catheters or probes having position sensors deployed within the body lumen, such as the interior of a cardiac chamber. These types of positional sensors are typically used to determine the movement of a cardiac tissue surface or the electrical activity within the cardiac tissue. When a sufficient number of points have been sampled by the sensors, a “map” of the cardiac tissue may be generated.
Another conventional device utilizes an inflatable balloon which is typically introduced intravascularly in a deflated state and then inflated against the tissue region to be examined. Imaging is typically accomplished by an optical fiber or other apparatus such as electronic chips for viewing the tissue through the membrane(s) of the inflated balloon. Moreover, the balloon must generally be inflated for imaging. Other conventional balloons utilize a cavity or depression formed at a distal end of the inflated balloon. This cavity or depression is pressed against the tissue to be examined and is flushed with a clear fluid to provide a clear pathway through the blood.
However, such imaging balloons have many inherent disadvantages. For instance, such balloons generally require that the balloon be inflated to a relatively large size which may undesirably displace surrounding tissue and interfere with fine positioning of the imaging system against the tissue. Moreover, the working area created by such inflatable balloons are generally cramped and limited in size. Furthermore, inflated balloons may be susceptible to pressure changes in the surrounding fluid. For example, if the environment surrounding the inflated balloon undergoes pressure changes, e.g., during systolic and diastolic pressure cycles in a beating heart, the constant pressure change may affect the inflated balloon volume and its positioning to produce unsteady or undesirable conditions for optimal tissue imaging.
Accordingly, these types of imaging modalities are generally unable to provide desirable images useful for sufficient diagnosis and therapy of the endoluminal structure, due in part to factors such as dynamic forces generated by the natural movement of the heart. Moreover, anatomic structures within the body can occlude or obstruct the image acquisition process. Also, the presence and movement of opaque bodily fluids such as blood generally make in vivo imaging of tissue regions within the heart difficult.
Other external imaging modalities are also conventionally utilized. For example, computed tomography (CT) and magnetic resonance imaging (MRI) are typical modalities which are widely used to obtain images of body lumens such as the interior chambers of the heart. However, such imaging modalities fail to provide real-time imaging for intra-operative therapeutic procedures. Fluoroscopic imaging, for instance, is widely used to identify anatomic landmarks within the heart and other regions of the body. However, fluoroscopy fails to provide an accurate image of the tissue quality or surface and also fails to provide for instrumentation for performing tissue manipulation or other therapeutic procedures upon the visualized tissue regions. In addition, fluoroscopy provides a shadow of the intervening tissue onto a plate or sensor when it may be desirable to view the intraluminal surface of the tissue to diagnose pathologies or to perform some form of therapy on it.
Thus, a tissue imaging system which is able to provide real-time in vivo images of tissue regions within body lumens such as the heart through opaque media such as blood and which also provide instruments for therapeutic procedures upon the visualized tissue are desirable.
A tissue imaging and manipulation apparatus that may be utilized for procedures within a body lumen, such as the heart, in which visualization of the surrounding tissue is made difficult, if not impossible, by medium contained within the lumen such as blood, is described below. Generally, such a tissue imaging and manipulation apparatus comprises an optional delivery catheter or sheath through which a deployment catheter and imaging hood may be advanced for placement against or adjacent to the tissue to be imaged.
The deployment catheter may define a fluid delivery lumen therethrough as well as an imaging lumen within which an optical imaging fiber or assembly may be disposed for imaging tissue. When deployed, the imaging hood may be expanded into any number of shapes, e.g., cylindrical, conical as shown, semi-spherical, etc., provided that an open area or field is defined by the imaging hood. The open area is the area within which the tissue region of interest may be imaged. The imaging hood may also define an atraumatic contact lip or edge for placement or abutment against the tissue region of interest. Moreover, the distal end of the deployment catheter or separate manipulatable catheters may be articulated through various controlling mechanisms such as push-pull wires manually or via computer control
The deployment catheter may also be stabilized relative to the tissue surface through various methods. For instance, inflatable stabilizing balloons positioned along a length of the catheter may be utilized, or tissue engagement anchors may be passed through or along the deployment catheter for temporary engagement of the underlying tissue.
In operation, after the imaging hood has been deployed, fluid may be pumped at a positive pressure through the fluid delivery lumen until the fluid fills the open area completely and displaces any blood from within the open area. The fluid may comprise any biocompatible fluid, e.g., saline, water, plasma, Fluorinert™, etc., which is sufficiently transparent to allow for relatively undistorted visualization through the fluid. The fluid may be pumped continuously or intermittently to allow for image capture by an optional processor which may be in communication with the assembly.
In an exemplary variation for imaging tissue surfaces within a heart chamber containing blood, the tissue imaging and treatment system may generally comprise a catheter body having a lumen defined therethrough, a visualization element disposed adjacent the catheter body, the visualization element having a field of view, a transparent fluid source in fluid communication with the lumen, and a barrier or membrane extendable from the catheter body to localize, between the visualization element and the field of view, displacement of blood by transparent fluid that flows from the lumen, and a piercing instrument translatable through the displaced blood for piercing into the tissue surface within the field of view.
The imaging hood may be formed into any number of configurations and the imaging assembly may also be utilized with any number of therapeutic tools which may be deployed through the deployment catheter.
More particularly in certain variations, the tissue visualization system may comprise components including the imaging hood, where the hood may further include a membrane having a main aperture and additional optional openings disposed over the distal end of the hood. An introducer sheath or the deployment catheter upon which the imaging hood is disposed may further comprise a steerable segment made of multiple adjacent links which are pivotably connected to one another and which may be articulated within a single plane or multiple planes. The deployment catheter itself may be comprised of a multiple lumen extrusion, such as a four-lumen catheter extrusion, which is reinforced with braided stainless steel fibers to provide structural support. The proximal end of the catheter may be coupled to a handle for manipulation and articulation of the system.
To facilitate the transseptal puncture, a piercing needle having a needle sheath, e.g., made with PEEK, or a needle sheath having a tapered or sharpened bevel at its distal end may be advanced through the catheter and advanced into and through the imaging hood. To provide visualization, an imaging element such as a fiberscope or electronic imager such as a solid state camera, e.g., CCD or CMOS, may be mounted, e.g., on a shape memory wire, and positioned within or along the hood interior. A fluid reservoir and/or pump (e.g., syringe, pressurized intravenous bag, etc.) may be fluidly coupled to the proximal end of the catheter to hold the translucent fluid such as saline or contrast medium as well as for providing the pressure to inject the fluid into the imaging hood.
One particular procedure for which the imaging hood and deployment catheter may be utilized includes crossing through a septal wall, e.g., the atrial septum, for transseptally accessing an atrial chamber such as the left atrium while under direct visualization. In particular, the devices and assemblies may be configured to facilitate passage across the atrial septum from the right atrium to the left atrium.
A method for accessing the left atrium of the heart via the septum of the heart, may generally comprise introducing a fluid into the right atrium of the heart, confining the fluid, during beating of the heart, so that blood is displaced sufficiently to allow visualization through the fluid of the surface region of the septum, and under guidance of the visualization of the surface region through the fluid, piercing through a safe transseptal access site within the surface region of the septum. Confinement or containment of the fluid occurs locally within the imaging hood which itself is immersed and surrounded by blood within the heart chamber such that when the translucent fluid is introduced into the imaging hood, the fluid is confined between the hood and tissue surface to be visualized while the surrounding blood remains within the heart chamber.
More particularly, an exemplary method for achieving transseptal puncture and access utilizing the tissue visualization system may comprise intravascularly introducing a sheath into the right atrium of the patient's heart. The imaging hood may be deployed from the introducer sheath within the atrial chamber and contacted against the septal wall, where the surrounding blood may be cleared from within the hood and the underlying tissue may be visualized. Alternatively, the hood may be moved along the tissue wall without clearing the blood from within the hood. As the imaging hood is moved to locate an anatomical landmark such as the fossa ovalis, tactile feedback may be utilized by the physician as a first indicator that the hood has contacted the fossa ovalis and/or the limbus of the fossa ovalis.
Once the fossa ovalis and/or the limbus of the fossa ovalis has been detected, the translucent fluid may be injected into the hood interior to displace the surrounding blood and to provide a clear visual indication of the fossa ovalis surface as a second confirmation that the imaging hood is suitably positioned along the fossa ovalis. The hood may be optionally further moved along the atrial tissue surface inferiorly while under direct visualization until the coronary sinus is visualized as a third indicator and backup confirmation that the fossa ovalis has been located. With the hood positioned over the fossa ovalis and directly visualizing the pale white tissue surface of the fossa, a piercing needle within a needle sheath or a separate beveled sheath may be advanced through the catheter and into the imaging hood where the needle may be pierced into and through the fossa ovalis while under direct visualization. Once the needle has pierced through the tissue and extended into the adjacent atrial chamber, i.e., the left atrial chamber, the piercing needle (if the needle is used) may be retracted to leave the needle sheath passing through the fossa ovalis and extending into the left atrium. A guidewire may be advanced through the sheath to access the left atrium whereupon the sheath may be retracted to leave the guidewire passing through the fossa ovalis and crossing between the left and right atrial chambers. The imaging hood and catheter may then be withdrawn leaving the guidewire passing through the fossa ovalis such that other instrument may be passed along or over the guidewire to access the left atrium.
One variation of the assembly may utilize an off-axis imaging element such as a CCD or CMOS imager, mounted along the hood interior as well as a piercing needle, which may further define one or more tissue engaging features, e.g., helical screw or threads, proximal to the piercing tip for facilitating tissue engagement. When deployed, the imaging hood may be advanced via the deployment catheter distally of the sheath whereupon the hood may be expanded into its deployed configuration. Once a targeted region of tissue, such as the atrial septum, has been engaged the needle may be advanced to pierce through the tissue wall and the guidewire may be advanced through a lumen defined within the needle into the atrial chamber.
The tissue-imaging catheter may be articulated via a steerable portion to direct the distal end towards the atrial septum. The deployment catheter and imaging hood may then be deployed from the sheath and advanced towards the wall of the atrial septum where it may be positioned, e.g., to locate the fossa ovalis along the septal wall. The catheter could be repositioned if necessary to determine the best location to cross the fossa ovalis using a transseptal puncture. Once positioned, the tissue engager may be utilized to temporarily engage or grab onto the underlying tissue to provide for a relatively secure positioning between the hood and the tissue.
Another variation of a method for obtaining transseptal access may utilize a tissue grasper to engage the tissue allowing the penetrating needle to cross the atrial septum by pulling proximally on the tissue with the tissue graspers and distally pushing the needle across the tissue layer. The guidewire may be concentrically positioned within the needle and subsequently advanced into the left atrium. By pulling proximally on the tissue towards the interior of hood, tenting of the tissue into the left atrium may be avoided when pushing distally with the needle upon the tissue wall. Moreover, by pulling proximally on the tissue, accidental puncturing of surrounding anatomical structures may be potentially avoided when passing the needle through the tissue by preventing or inhibiting tissue tenting.
Yet another variation for the tissue visualization assembly includes a translucent imaging balloon which may be optionally included in combination with the imaging hood for inflation and placement against the tissue surface to provide the physician an initial determination of a position of the catheter distal end prior to expansion of the visualization imaging hood and/or prior to deployment of the imaging hood against the tissue wall. The imaging hood may be expanded and the balloon may be inflated and positioned within the hood or distal thereof to allow the underlying tissue surface to be visualized by pressing the balloon against the tissue surface prior to hood expansion and/or deployment to provide an initial image and visual assessment of the catheter location relative to the atrial septum.
If the initial visual assessment indicates that the catheter should be moved to another location for transseptal puncture, the catheter position may be adjusted and moved while visualizing against the tissue wall or the catheter may be removed from the tissue wall and repositioned for another visual assessment. Alternatively, the balloon may be deflated and the catheter repositioned to another location along the tissue wall, where the balloon may again be re-inflated for visualization. Once the catheter position has been visually confirmed as being positioned at a desirable location for puncture, the balloon may be deflated and optionally withdrawn from the imaging hood and the purging fluid may be pumped into the hood to provide the open space for visualization and treatment by additional tools.
In yet other variations for accomplishing intravascular transseptal access, the imaging assembly may be utilized with various introduction sheaths to facilitate the articulation and positioning of the imaging hood with respect to the septal wall. Such an introduction sheath may be curved or pre-bent such that its distal portion is angled towards or away from the septal wall when positioned within the patient's heart. Alternatively, the sheath may simply extend in a straightened configuration.
In utilizing the imaging hood in any one of the procedures described herein, the hood may have an open field which is uncovered and clear to provide direct tissue contact between the hood interior and the underlying tissue to effect any number of treatments upon the tissue, as described above. Yet in additional variations, the imaging hood may utilize other configurations where the imaging hood includes at least one layer of a transparent elastomeric membrane over the distal opening of the hood. An aperture having a diameter which is less than a diameter of the outer lip of imaging hood may be defined over the center of membrane where a longitudinal axis of the hood intersects the membrane such that the interior of the hood remains open and in fluid communication with the environment external to the hood. Furthermore, the aperture may be sized, e.g., between 1 to 2 mm or more in diameter and the membrane can be made from any number of transparent elastomers such as silicone, polyurethane, latex, etc. such that contacted tissue may also be visualized through the membrane as well as through the aperture. The membrane itself may define a plurality of openings which may optionally be adjusted in size depending upon the desired fluid flow characteristics.
Yet another feature which may be utilized with any of the embodiments described above, particularly for transseptal puncture, may include the use of a needle body positioned through the catheter and having multi-colored gradations or markings along its shaft extending from the needle tip used in conjunction with the tissue visualization catheter. The needle can be of varying sizes and diameters with segments along the body marked with different colors. The needle may also have markings or gradations engraved or otherwise marked along the body of the needle to visually indicate a length of the needle in millimeters or inches.
The operator may gauge the depth of needle penetration into the tissue by correlating the exposed colored gradations or markings. When the needle penetrates the tissue, the exposed markings just above the tissue surface can be read under direct visualization provided by the tissue visualization catheter. Direct visualization is achieved by the CCD/CMOS camera built-in the catheter and by flushing opaque bodily fluid such as blood, out of the interior of the hood using clear saline.
Generally, the tissue visualization system described herein may provide for several advantages in intravascular transseptal access. For instance, direct visualization of the underlying tissue such as the fossa ovalis may be obtained as well as visualization of other anatomical landmarks such as the coronary sinus. Visual confirmation of the coronary sinus location, for instance, may be utilized as an orientation indicator to locate and/or confirm a location of the fossa ovalis given the proximity of the fossa ovalis and the coronary sinus to one another. This may be particularly useful in providing a method for identifying an anatomical feature, such as the coronary sinus, that is relatively easy to identify visually to help locate another anatomical feature which is relatively more difficult to identify visually, such as the fossa ovalis. Additionally, in initially accessing the septal wall, the sheath may be curved or pre-bent to point away from the septal wall to allow for the deployment catheter carrying the imaging hood to be curved and steered towards the septal wall particularly when there is limited space in the right atrium for maneuvering the imaging hood.
Moreover, while undergoing transseptal puncture with a piercing instrument through the septal wall, the tissue imaging system provides a mechanism for directly visualizing the entire procedure of inserting and passing a needle, for instance, through the fossa ovalis and passing the guidewire into the left atrium. Additionally, because the puncturing of the tissue is directly visualized, excessive tenting or distortion of the septal wall by the piercing instrument may be visually monitored where blood entering the visual field within the hood is an indication that the underlying tissue is distorting and thus causing poor contact between the imaging hood and the underlying tissue.
A tissue-imaging and manipulation apparatus described below is able to provide real-time images in vivo of tissue regions within a body lumen such as a heart, which is filled with blood flowing dynamically therethrough and is also able to provide intravascular tools and instruments for performing various procedures upon the imaged tissue regions. Such an apparatus may be utilized for many procedures, e.g., facilitating transseptal access to the left atrium, cannulating the coronary sinus, diagnosis of valve regurgitation/stenosis, valvuloplasty, atrial appendage closure, arrhythmogenic focus ablation, among other procedures.
One variation of a tissue access and imaging apparatus is shown in the detail perspective views of
When the imaging and manipulation assembly 10 is ready to be utilized for imaging tissue, imaging hood 12 may be advanced relative to catheter 14 and deployed from a distal opening of catheter 14, as shown by the arrow. Upon deployment, imaging hood 12 may be unconstrained to expand or open into a deployed imaging configuration, as shown in
Imaging hood 12 may be attached at interface 24 to a deployment catheter 16 which may be translated independently of deployment catheter or sheath 14. Attachment of interface 24 may be accomplished through any number of conventional methods. Deployment catheter 16 may define a fluid delivery lumen 18 as well as an imaging lumen 20 within which an optical imaging fiber or assembly may be disposed for imaging tissue. When deployed, imaging hood 12 may expand into any number of shapes, e.g., cylindrical, conical as shown, semi-spherical, etc., provided that an open area or field 26 is defined by imaging hood 12. The open area 26 is the area within which the tissue region of interest may be imaged. Imaging hood 12 may also define an atraumatic contact lip or edge 22 for placement or abutment against the tissue region of interest. Moreover, the diameter of imaging hood 12 at its maximum fully deployed diameter, e.g., at contact lip or edge 22, is typically greater relative to a diameter of the deployment catheter 16 (although a diameter of contact lip or edge 22 may be made to have a smaller or equal diameter of deployment catheter 16). For instance, the contact edge diameter may range anywhere from 1 to 5 times (or even greater, as practicable) a diameter of deployment catheter 16.
The imaging and manipulation assembly 10 may additionally define a guidewire lumen therethrough, e.g., a concentric or eccentric lumen, as shown in the side and end views, respectively, of
In operation, after imaging hood 12 has been deployed, as in
As seen in the example of
Although contact edge 22 need not directly contact the underlying tissue, it is at least preferably brought into close proximity to the tissue such that the flow of clear fluid 28 from open area 26 may be maintained to inhibit significant backflow of blood 30 back into open area 26. Contact edge 22 may also be made of a soft elastomeric material such as certain soft grades of silicone or polyurethane, as typically known, to help contact edge 22 conform to an uneven or rough underlying anatomical tissue surface. Once the blood 30 has been displaced from imaging hood 12, an image may then be viewed of the underlying tissue through the clear fluid 30. This image may then be recorded or available for real-time viewing for performing a therapeutic procedure. The positive flow of fluid 28 may be maintained continuously to provide for clear viewing of the underlying tissue. Alternatively, the fluid 28 may be pumped temporarily or sporadically only until a clear view of the tissue is available to be imaged and recorded, at which point the fluid flow 28 may cease and blood 30 may be allowed to seep or flow back into imaging hood 12. This process may be repeated a number of times at the same tissue region or at multiple tissue regions.
In desirably positioning the assembly at various regions within the patient body, a number of articulation and manipulation controls may be utilized. For example, as shown in the articulatable imaging assembly 40 in
Additionally or alternatively, an articulatable delivery catheter 48, which may be articulated via one or more push-pull wires and having an imaging lumen and one or more working lumens, may be delivered through the deployment catheter 16 and into imaging hood 12. With a distal portion of articulatable delivery catheter 48 within imaging hood 12, the clear displacing fluid may be pumped through delivery catheter 48 or deployment catheter 16 to clear the field within imaging hood 12. As shown in
Alternatively, rather than passing an articulatable delivery catheter 48 through the deployment catheter 16, a distal portion of the deployment catheter 16 itself may comprise a distal end 49 which is articulatable within imaging hood 12, as shown in
Visualization within the imaging hood 12 may be accomplished through an imaging lumen 20 defined through deployment catheter 16, as described above. In such a configuration, visualization is available in a straight-line manner, i.e., images are generated from the field distally along a longitudinal axis defined by the deployment catheter 16. Alternatively or additionally, an articulatable imaging assembly having a pivotable support member 50 may be connected to, mounted to, or otherwise passed through deployment catheter 16 to provide for visualization off-axis relative to the longitudinal axis defined by deployment catheter 16, as shown in
If one or more optical fibers are utilized for imaging, the optical fibers 58 may be passed through deployment catheter 16, as shown in the cross-section of
In accessing regions of the heart H or other parts of the body, the delivery catheter or sheath 14 may comprise a conventional intra-vascular catheter or an endoluminal delivery device. Alternatively, robotically-controlled delivery catheters may also be optionally utilized with the imaging assembly described herein, in which case a computer-controller 74 may be used to control the articulation and positioning of the delivery catheter 14. An example of a robotically-controlled delivery catheter which may be utilized is described in further detail in US Pat. Pub. 2002/0087169 A1 to Brock et al. entitled “Flexible Instrument”, which is incorporated herein by reference in its entirety. Other robotically-controlled delivery catheters manufactured by Hansen Medical, Inc. (Mountain View, Calif.) may also be utilized with the delivery catheter 14.
To facilitate stabilization of the deployment catheter 16 during a procedure, one or more inflatable balloons or anchors 76 may be positioned along the length of catheter 16, as shown in
To further stabilize a position of the imaging hood 12 relative to a tissue surface to be imaged, various anchoring mechanisms may be optionally employed for temporarily holding the imaging hood 12 against the tissue. Such anchoring mechanisms may be particularly useful for imaging tissue which is subject to movement, e.g., when imaging tissue within the chambers of a beating heart. A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through deployment catheter 16 and into an expanded imaging hood 12. As the imaging hood 12 is brought into contact against a tissue surface T to be examined, anchoring mechanisms such as a helical tissue piercing device 84 may be passed through the tool delivery catheter 82, as shown in
The helical tissue engaging device 84 may be torqued from its proximal end outside the patient body to temporarily anchor itself into the underlying tissue surface T. Once embedded within the tissue T, the helical tissue engaging device 84 may be pulled proximally relative to deployment catheter 16 while the deployment catheter 16 and imaging hood 12 are pushed distally, as indicated by the arrows in
Although a helical anchor 84 is shown, this is intended to be illustrative and other types of temporary anchors may be utilized, e.g., hooked or barbed anchors, graspers, etc. Moreover, the tool delivery catheter 82 may be omitted entirely and the anchoring device may be delivered directly through a lumen defined through the deployment catheter 16.
In another variation where the tool delivery catheter 82 may be omitted entirely to temporarily anchor imaging hood 12,
An illustrative example is shown in
Optionally, processor 98 may also be utilized to coordinate the fluid flow and the image capture. For instance, processor 98 may be programmed to provide for fluid flow from reservoir 96 until the tissue area has been displaced of blood to obtain a clear image. Once the image has been determined to be sufficiently clear, either visually by a practitioner or by computer, an image of the tissue may be captured automatically by recorder 100 and pump 92 may be automatically stopped or slowed by processor 98 to cease the fluid flow into the patient. Other variations for fluid delivery and image capture are, of course, possible and the aforementioned configuration is intended only to be illustrative and not limiting.
Deployment of imaging hood 12 may be actuated by a hood deployment switch 120 located on the handle assembly 112 while dispensation of the fluid from reservoir 114 may be actuated by a fluid deployment switch 122, which can be electrically coupled to the controller 118. Controller 118 may also be electrically coupled to a wired or wireless antenna 124 optionally integrated with the handle assembly 112, as shown in the figure. The wireless antenna 124 can be used to wirelessly transmit images captured from the imaging hood 12 to a receiver, e.g., via Bluetooth® wireless technology (Bluetooth SIG, Inc., Bellevue, Wash.), RF, etc., for viewing on a monitor 128 or for recording for later viewing.
Articulation control of the deployment catheter 16, or a delivery catheter or sheath 14 through which the deployment catheter 16 may be delivered, may be accomplished by computer control, as described above, in which case an additional controller may be utilized with handle assembly 112. In the case of manual articulation, handle assembly 112 may incorporate one or more articulation controls 126 for manual manipulation of the position of deployment catheter 16. Handle assembly 112 may also define one or more instrument ports 130 through which a number of intravascular tools may be passed for tissue manipulation and treatment within imaging hood 12, as described further below. Furthermore, in certain procedures, fluid or debris may be sucked into imaging hood 12 for evacuation from the patient body by optionally fluidly coupling a suction pump 132 to handle assembly 112 or directly to deployment catheter 16.
As described above, fluid may be pumped continuously into imaging hood 12 to provide for clear viewing of the underlying tissue. Alternatively, fluid may be pumped temporarily or sporadically only until a clear view of the tissue is available to be imaged and recorded, at which point the fluid flow may cease and the blood may be allowed to seep or flow back into imaging hood 12.
The deployment catheter 16 may be then repositioned to an adjacent portion of mitral valve MV, as shown in
As mentioned above, when the imaging hood 12 is cleared by pumping the imaging fluid within for clearing the blood or other bodily fluid, the fluid may be pumped continuously to maintain the imaging fluid within the hood 12 at a positive pressure or it may be pumped under computer control for slowing or stopping the fluid flow into the hood 12 upon detection of various parameters or until a clear image of the underlying tissue is obtained. The control electronics 118 may also be programmed to coordinate the fluid flow into the imaging hood 12 with various physical parameters to maintain a clear image within imaging hood 12.
One example is shown in
The variations in fluid pressure within imaging hood 12 may be accomplished in part due to the nature of imaging hood 12. An inflatable balloon, which is conventionally utilized for imaging tissue, may be affected by the surrounding blood pressure changes. On the other hand, an imaging hood 12 retains a constant volume therewithin and is structurally unaffected by the surrounding blood pressure changes, thus allowing for pressure increases therewithin. The material that hood 12 is made from may also contribute to the manner in which the pressure is modulated within this hood 12. A stiffer hood material, such as high durometer polyurethane or Nylon, may facilitate the maintaining of an open hood when deployed. On the other hand, a relatively lower durometer or softer material, such as a low durometer PVC or polyurethane, may collapse from the surrounding fluid pressure and may not adequately maintain a deployed or expanded hood.
Turning now to the imaging hood, other variations of the tissue imaging assembly may be utilized, as shown in
In deploying the imaging hood in the examples described herein, the imaging hood may take on any number of configurations when positioned or configured for a low-profile delivery within the delivery catheter, as shown in the examples of
Another variation for expanding the imaging hood is shown in
Yet another configuration for the imaging hood may be seen in
Although it is generally desirable to have an imaging hood contact against a tissue surface in a normal orientation, the imaging hood may be alternatively configured to contact the tissue surface at an acute angle. An imaging hood configured for such contact against tissue may also be especially suitable for contact against tissue surfaces having an unpredictable or uneven anatomical geography. For instance, as shown in the variation of
In yet another alternative,
Another variation for ensuring contact between imaging hood 282 and the underlying tissue may be seen in
Aside from the imaging hood, various instrumentation may be utilized with the imaging and manipulation system. For instance, after the field within imaging hood 12 has been cleared of the opaque blood and the underlying tissue is visualized through the clear fluid, blood may seep back into the imaging hood 12 and obstruct the view. One method for automatically maintaining a clear imaging field may utilize a transducer, e.g., an ultrasonic transducer 290, positioned at the distal end of deployment catheter within the imaging hood 12, as shown in
Alternatively, one or more sensors 300 may be positioned on the imaging hood 12 itself, as shown in
Alternative methods for detecting the presence of blood within the hood 12 may include detecting transmitted light through the imaging fluid within imaging hood 12. If a source of white light, e.g., utilizing LEDs or optical fibers, is illuminated inside imaging hood 12, the presence of blood may cause the color red to be filtered through this fluid. The degree or intensity of the red color detected may correspond to the amount of blood present within imaging hood 12. A red color sensor can simply comprise, in one variation, a phototransistor with a red transmitting filter over it which can establish how much red light is detected, which in turn can indicate the presence of blood within imaging hood 12. Once blood is detected, the system may pump more clearing fluid through and enable closed loop feedback control of the clearing fluid pressure and flow level.
Any number of sensors may be positioned along the exterior 302 of imaging hood 12 or within the interior 304 of imaging hood 12 to detect parameters not only exteriorly to imaging hood 12 but also within imaging hood 12. Such a configuration, as shown in
Aside from sensors, one or more light emitting diodes (LEDs) may be utilized to provide lighting within the imaging hood 12. Although illumination may be provided by optical fibers routed through deployment catheter 16, the use of LEDs over the imaging hood 12 may eliminate the need for additional optical fibers for providing illumination. The electrical wires connected to the one or more LEDs may be routed through or over the hood 12 and along an exterior surface or extruded within deployment catheter 16. One or more LEDs may be positioned in a circumferential pattern 306 around imaging hood 12, as shown in
In another alternative for illumination within imaging hood 12, a separate illumination tool 310 may be utilized, as shown in
In utilizing LEDs for illumination, whether positioned along imaging hood 12 or along a separate instrument, the LEDs may comprise a single LED color, e.g., white light. Alternatively, LEDs of other colors, e.g., red, blue, yellow, etc., may be utilized exclusively or in combination with white LEDs to provide for varied illumination of the tissue or fluids being imaged. Alternatively, sources of infrared or ultraviolet light may be employed to enable imaging beneath the tissue surface or cause fluorescence of tissue for use in system guidance, diagnosis, or therapy.
Aside from providing a visualization platform, the imaging assembly may also be utilized to provide a therapeutic platform for treating tissue being visualized. As shown in
In yet another alternative,
Alternative configurations for tools which may be delivered through deployment catheter 16 for use in tissue manipulation within imaging hood 12 are shown in
Other instruments or tools which may be utilized with the imaging system is shown in the side and end views of
In the case of an end effector 372 utilized for ablation of the underlying tissue, an additional temperature sensor such as a thermocouple or thermistor 374 positioned upon an elongate member 376 may be advanced into the imaging hood 12 adjacent to the distal end effector 372 for contacting and monitoring a temperature of the ablated tissue.
In either example described above, the imaging fluid may be varied in its temperature to facilitate various procedures to be performed upon the tissue. In other cases, the imaging fluid itself may be altered to facilitate various procedures. For instance as shown in
As the cryo-fluid leaks out of the imaging hood 12 and into the organ, the fluid may be warmed naturally by the patient body and ultimately removed. The cryo-fluid may be a colorless and translucent fluid which enables visualization therethrough of the underlying tissue. An example of such a fluid is Fluorinert™ (3M, St. Paul, Minn.), which is a colorless and odorless perfluorinated liquid. The use of a liquid such as Fluorinert™ enables the cryo-ablation procedure without the formation of ice within or outside of the imaging hood 12. Alternatively, rather than utilizing cryo-ablation, hyperthermic treatments may also be effected by heating the Fluorinert™ liquid to elevated temperatures for ablating the lesion 392 within the imaging hood 12. Moreover, Fluorinert™ may be utilized in various other parts of the body, such as within the heart.
When using the laser energy to ablate the tissue of the heart, it may be generally desirable to maintain the integrity and health of the tissue overlying the surface while ablating the underlying tissue. This may be accomplished, for example, by cooling the imaging fluid to a temperature below the body temperature of the patient but which is above the freezing point of blood (e.g., 2° C. to 35° C.). The cooled imaging fluid may thus maintain the surface tissue at the cooled fluid temperature while the deeper underlying tissue remains at the patient body temperature. When the laser energy (or other types of energy such as radio frequency energy, microwave energy, ultrasound energy, etc.) irradiates the tissue, both the cooled tissue surface as well as the deeper underlying tissue will rise in temperature uniformly. The deeper underlying tissue, which was maintained at the body temperature, will increase to temperatures which are sufficiently high to destroy the underlying tissue. Meanwhile, the temperature of the cooled surface tissue will also rise but only to temperatures that are near body temperature or slightly above.
Accordingly, as shown in
One of the difficulties in treating tissue in or around the ostium OT is the dynamic fluid flow of blood through the ostium OT. The dynamic forces make cannulation or entry of the ostium OT difficult. Thus, another variation on instruments or tools utilizable with the imaging system is an extendible cannula 410 having a cannula lumen 412 defined therethrough, as shown in
In use, once the imaging hood 12 has been desirably positioned relative to the tissue, e.g., as shown in
Yet another variation for tool or instrument use may be seen in the side and end views of
Various methods and instruments may be utilized for using or facilitating the use of the system. For instance, one method may include facilitating the initial delivery and placement of a device into the patient's heart. In initially guiding the imaging assembly within the heart chamber to, e.g., the mitral valve MV, a separate guiding probe 430 may be utilized, as shown in
Aside from the devices and methods described above, the imaging system may be utilized to facilitate various other procedures. Turning now to
The disk-shaped member 440 may be comprised of a variety of materials depending upon the application. For instance, member 440 may be fabricated from a porous polymeric material infused with a drug eluting medicament 442 for implantation against a tissue surface for slow infusion of the medicament into the underlying tissue. Alternatively, the member 440 may be fabricated from a non-porous material, e.g., metal or polymer, for implantation and closure of a wound or over a cavity to prevent fluid leakage. In yet another alternative, the member 440 may be made from a distensible material which is secured to imaging hood 12 in an expanded condition. Once implanted or secured on a tissue surface or wound, the expanded member 440 may be released from imaging hood 12. Upon release, the expanded member 440 may shrink to a smaller size while approximating the attached underlying tissue, e.g., to close a wound or opening.
One method for securing the disk-shaped member 440 to a tissue surface may include a plurality of tissue anchors 444, e.g., barbs, hooks, projections, etc., which are attached to a surface of the member 440. Other methods of attachments may include adhesives, suturing, etc. In use, as shown in
Another variation for tissue manipulation and treatment may be seen in the variation of
One example for use of the anchor assembly 450 is shown in
Another example for an alternative use is shown in
Yet another variation is shown in
Another variation of a deployment catheter 500 which may be used for imaging tissue to the side of the instrument may be seen in
In use, deployment catheter 500 may be advanced intravascularly through vessel lumen 488 towards a lesion or tumor 508 to be visualized and/or treated. Upon reaching the lesion 508, deployment catheter 500 may be positioned adjacently to the lesion 508 and balloon 502 may be inflated such that the lesion 508 is contained within the visualization field 506. Once balloon 502 is fully inflated and in contact against the vessel wall, clear fluid may be pumped into visualization field 506 through deployment catheter 500 to displace any blood or opaque fluids from the field 506, as shown in the side and end views of
In additional variations of the imaging hood and deployment catheter, the various assemblies may be configured in particular for crossing through a septal wall, e.g., the atrial septum AS, for trans-septally accessing an atrial chamber such as the left atrium LA, also as illustrated above in
One variation of assembly 510 is illustrated in the partial cross-sectional side view in
When deployed, imaging hood 12 may be advanced via deployment catheter 16 distally of sheath 14, whereupon hood 12 may be expanded into its deployed configuration, as shown in
Another variation is illustrated in the side view of
The tissue-imaging catheter provides a clear direct visualization within the heart allowing instruments within the imaging hood to perform various procedures, such as a trans-septal procedure for locating and crossing a device from the right atrium RA to the left atrium LA via the atrial septum AS.
The catheter assembly may contain a number of articulation and manipulation controls. For example, one or more push-pull wires may be used for steering the distal end portion of the device in various directions to desirably position the imaging hood 12 adjacent to a region of tissue to be visualized. The push-pull wire or wires may be articulated via their proximal ends from outside the patient body. Alternatively, the deployment catheter may be articulated by computer control, as described above.
To obtain a visible image, the imaging hood 12 may be purged with the displacing fluid 526 pumped at a positive pressure through a fluid delivery lumen until the fluid fills the open area or field 26 within hood 12 partially or completely and displaces the blood within hood 12, as shown in
Once the imaging hood 12 has been cleared and direct visual confirmation of the underlying tissue has been obtained by the physician, piercing needle 520 may be advanced within hood 12 while under direct visualization, as shown in
In another variation for crossing the atrial septum AS,
Yet another variation for the tissue visualization assembly is illustrated in the side views of
As shown in
If the initial visual assessment indicates that the catheter should be moved to another location for trans-septal puncture, the catheter position may be adjusted and moved while visualizing against the tissue wall or the catheter may be removed from the tissue wall and repositioned for another visual assessment. Alternatively, balloon 540 may be deflated and the catheter repositioned to another location along the tissue wall, where balloon 540 may again be re-inflated for visualization. Once the catheter position has been visually confirmed as being positioned at a desirable location for puncture, the balloon 540 may be deflated and optionally withdrawn from imaging hood 12 and the purging fluid may be pumped into hood 12 to provide the open space for visualization and treatment by additional tools, as described above.
Alternatively, as shown in
In yet another variation, as shown in
In yet another variation, the tissue can be engaged using a cryo-probe configured to reduce its temperature to below 0° C. to temporarily adhere to the underlying tissue. Once the probe temperature has been reduced, it may be adhered to the tissue to engage it and once the procedure has been completed, the probe may be allowed to warm or heated to thus release the adhered tissue. Another variation utilizing an energizable probe 560 using an energy modality (e.g., a radio-frequency, laser, microwave, high intensity ultrasound, etc.) may be used to pierce or pass through the septal wall, as shown in
In yet other variations for accomplishing intravascular trans-septal access, the imaging assembly may be utilized with various introduction sheaths to facilitate the articulation and positioning of the imaging hood 12 with respect to the septal wall. One example of an introduction assembly 570 is illustrated in
Handle 576 may be manipulated by the physician from outside the patient body and may also include one or more entry ports for providing intravascular access from outside the patient body, through the catheter shaft 16, and into the body. Entry port 580 on handle 576 may be utilized for the insertion of an imager such as imaging assembly 524, which has imager connector 598 at its proximal end for connection to a video input. Fluid port 582 on handle 576 may provide entry for fluid channel 594 connected to fluid reservoir 596, e.g., a syringe, pressured fluid bag, motorized pump, etc., which is used to introduce the purging fluid within imaging hood 12. Entry port 584 on handle 576 can be utilized for the insertion of a piercing instrument, such as piercing instrument 600 having a piercing tip 602, e.g., needle body, beveled sheath tip, etc. for creating a trans-septal passage through the tissue wall.
The cross-sectional view of catheter 16 may also be seen illustrating one variation for the relative placement and positioning of lumens with respect to one another. As seen, imaging assembly lumen 586 for the passage of imager 524 and fluid lumen 588 and piercing instrument lumen 590 for instrument 600 may be adjacent to one another. Moreover, pullwire lumen 592 may also be shown for the routing of one or more push-pull wires therethrough which may be articulated via control 578 for effecting movement of imaging hood 12.
Also shown in the figure is introducer sheath 604 which defines an introducer sheath lumen 608 therethrough for the passage of imaging hood 12 and deployment catheter 16 therethrough within the body. Sheath 604 may optionally define a curved or pre-bent section 606 relative to a longitudinal axis of sheath 604 configured in one of several shapes to facilitate the movement of imaging hood 12 within the body, as described in further detail below. The curved or pre-bent section 606 may be angled relative to the sheath 604 anywhere in a range from 0° to 45° or more depending upon the desired angle of approach to the septal wall.
In utilizing an introducer sheath 604 having the curved or pre-bent section 606,
Once the imaging hood 12 has been suitably positioned along the atrial septum and direct visual confirmation of the underlying tissue has been accomplished, the piercing tip 602 of piercing instrument 600 may be advanced through imaging hood 12 while under direct visualization by imager 524 (or an electronic imager positioned along the hood interior wall, as described above), as shown in the partial cross-sectional view of
The piercing instrument 600 may be withdrawn from needle sheath 616, which may be left within the transseptal puncture 618 and as shown in
In another method, introducer sheath 604 having an oppositely curved or pre-bent section 620 may be utilized, as shown in
In yet another variation, an introducer sheath 604 having a straightened portion 622 may be utilized, as shown in
Another variation for approaching the atrial septum AS may include access through the superior vena cava SVC, as shown in
Whichever intravascular approach is taken, the visualization system is ideally suited for directly visualizing the targeted tissue. Direct in vivo visualization further enables a user to visually identify not only tissue regions generally, but also to distinguish between anatomical landmarks and to visually assess their condition in detail and in color. Such detailed assessment may further allow for a more thorough evaluation and treatment of the underlying tissue also utilizing the system described herein.
A further example of visualizing a tissue region is shown in
Another example of visually distinguishing anatomical landmarks may also include visualization of the coronary sinus CS ostium, located inferiorly to the fossa ovalis FO. As above, imaging hood 12 may be translated along the tissue wall of the atrial septum AS while under direct visualization through hood 12 until the ostium of the coronary sinus CS is located, as shown in
In yet another example, imaging hood 12 may be positioned along, adjacent to, or directly upon the fossa ovalis FO, as above and as shown in
As mentioned above, the imaging hood 12 may be utilized to indicate whether an excessive amount of force is imparted upon the tissue wall during a therapeutic procedure such as transseptal puncture. As also described above, in the case of transseptal puncture, once the open area 26 of imaging hood 12 has been deployed against or adjacent to the region of tissue to be imaged, the translucent fluid 28 may be pumped into the hood 12 via the deployment catheter 16 such that the surrounding opaque fluid, such as blood 30 is displaced from within the hood 12 and the underlying tissue may then be visualized through the translucent fluid 28. A needle sheath 616 and a piercing tip 602 projecting therefrom may be advanced through the hood 12 and pierced into or through the tissue creating a transseptal puncture 618 to access the body lumen, such as the left atrium, beyond the atrial septum AS while under the direct visualization of imager 524, as shown in
However, in cases where piercing tip 602 is advanced against the tissue wall and fails to pierce into or through the atrial septum AS, the underlying tissue may begin to distort or tent around the piercing instrument, as shown in
In yet another variation for utilizing the deployment catheter 16 and imaging hood 12, the catheter 16 may be used to facilitate the crossing of the tissue wall, e.g., through an atrial-septal defect (ASD) or patent foramen ovale (PFO) or through an artificially-created transseptal puncture or fistula. As illustrated in
In utilizing the imaging hood 12 in any one of the procedures described herein, the hood 12 may have an open field which is uncovered and clear to provide direct tissue contact between the hood interior and the underlying tissue to effect any number of treatments upon the tissue, as described above. Yet in additional variations, imaging hood 12 may utilize other configurations, as also described above. An additional variation of the imaging hood 12 is shown in the perspective and end views, respectively, of
Aperture 642 may function generally as a restricting passageway to reduce the rate of fluid out-flow from the hood 12 when the interior of the hood 12 is infused with the clear fluid through which underlying tissue regions may be visualized. Aside from restricting out-flow of clear fluid from within hood 12, aperture 642 may also restrict external surrounding fluids from entering hood 12 too rapidly. The reduction in the rate of fluid out-flow from the hood and blood in-flow into the hood may improve visualization conditions as hood 12 may be more readily filled with transparent fluid rather than being filled by opaque blood which may obstruct direct visualization by the visualization instruments.
Moreover, aperture 642 may be aligned with catheter 604 such that any instruments (e.g., piercing instruments, guidewires, tissue engagers, etc.) that are advanced into the hood interior may directly access the underlying tissue uninhibited or unrestricted for treatment through aperture 642. In other variations wherein aperture 642 may not be aligned with catheter 604, instruments passed through catheter 604 may still access the underlying tissue by simply piercing through membrane 640.
In an additional variation,
The reduction or closure of the flow reduction apertures 654 may facilitate the sealing of the hood 12 quickly due to the relatively small sized pores and the ability to potentially better distribute clear fluid out-flow over the distal cross sectional area of the hood 12 due to the plurality of small apertures rather than a single central aperture. Moreover, therapeutic instruments can be passed through the membrane 650 through any of the apertures 652 for treating the underlying tissue.
In yet another variation of a hood 12 configured to facilitate the introduction of the purging fluid within the visual field,
To access the underlying tissue, needle 672 may be advanced from needle sheath 670 from within imaging hood 12 to penetrate through balloon 676 directly to the target tissue 674, as shown in
Aside from utilizing a hooded structure, various other structures may be utilized for transseptal access within the heart.
In yet another variation, the inflatable structure 682 may also include a lumen or passageway 690 defined through the structure maintaining a passageway from the catheter 680 to the balloon opening 686 such that instruments passed through the structure may have an unimpeded or direct path to the underlying tissue, as shown in
Although the membrane of the partially-inflatable balloon may be formed of a uniform material, a proximal portion, e.g., a proximal hemispherical portion, may be reinforced with an additional layer 694, such as cloth, as shown in
Additional variations on the inflatable balloon structure may be seen in the partial cross-sectional side view of
Yet another feature which may be utilized with any of the embodiments described above, particularly for transseptal puncture, is shown in
Another method for determining depth of tissue penetration with the colored needle body 782 may utilize estimating the depth of penetration from the colored segment that is advanced into the tissue and no longer visible by the imaging element. For example, the colors may be coded to indicate a range of safe tissue penetration by the needle body 782. An example of this is to delineate a proximal portion of the needle body 782 as a safety limit of how far the needle may be penetrated into the tissue. As the needle 782 is advanced into the tissue, the operator may continue the advancement until, e.g., a red segment of the needle has been reached. Other portions of the needle body 782 may be color-coded in a likewise manner, e.g., having a green segment along the needle body 782 distal to the red safety limit to indicate a safe range in which to advance the needle. Such features may be utilized as a safety feature especially when the tissue visualization catheter is used for tissue puncture related procedures such as transseptal access within the heart.
As shown in
The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modification of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.
This application claims the benefit of priority to the following U.S. Prov. Pat. App. Ser. Nos. 60/804,801 filed Jun. 14, 2006; 60/806,924 filed Jul. 10, 2006; 60/806,926 filed Jul. 10, 2006; 60/871,415 filed Dec. 21, 2006; 60/871,424 filed Dec. 21, 2006; 60/888,242 filed Feb. 5, 2007; this is also a continuation-in-part of U.S. patent application Ser. No. 11/259,498 filed Oct. 25, 2005, which claims priority to U.S. Prov. Pat. App. Ser. No. 60/649,246 filed Feb. 2, 2005; and this is also a continuation-in-part of U.S. patent application Ser. No. 11/560,742 filed Nov. 16, 2006, which claims priority to 60/737,521 filed Nov. 16, 2005 and is a continuation-in-part of U.S. patent application Ser. No. 11/259,498 filed Oct. 25, 2005. Each application is incorporated herein by reference in its entirety.
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| Number | Date | Country | |
|---|---|---|---|
| 20070293724 A1 | Dec 2007 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60888242 | Feb 2007 | US | |
| 60871415 | Dec 2006 | US | |
| 60871424 | Dec 2006 | US | |
| 60806926 | Jul 2006 | US | |
| 60806924 | Jul 2006 | US | |
| 60804801 | Jun 2006 | US | |
| 60737521 | Nov 2005 | US | |
| 60649246 | Feb 2005 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11560742 | Nov 2006 | US |
| Child | 11763399 | US | |
| Parent | 11259498 | Oct 2005 | US |
| Child | 11560742 | US | |
| Parent | 11259498 | Oct 2005 | US |
| Child | 11560742 | US |
