BALLOON VISUALIZATION FOR TRAVERSING A TISSUE WALL
Systems and methods for controllably traversing a tissue wall. In one embodiment, a distal end of a catheter is positioned and/or repositioned utilizing direct visualization out the distal end of the catheter, as facilitated by an imaging element disposed within the distal tip of the catheter. An inflatable balloon may comprise a portion of the distal tip of the catheter for structural and/or visualization media purposes. A tissue traversing element may be forwarded through a working lumen defined by the catheter and controllably pushed through a tissue wall as observed with the imaging element. The tissue traversing element may comprise sensors and the like to facilitate monitoring of changes in pressure, color, oxygen saturation, flow rate, and echo timing, to determine the position of the tissue traversing member relative to the tissue wall.
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This application is a continuation of U.S. patent application Ser. No. 10/949,032 filed on Sep. 24, 2004 which claims the benefit of U.S. Provisional. Patent Application No. 60/506,293 filed Sep. 25, 2003, the contents of which are incorporated herein by reference in their entirety.
BACKGROUNDOne of the challenges in sending a medical device or portion thereof across a an internal body tissue wall is ensuring that the device is not advanced too far past the tissue wall, which can damage adjacent tissue structures. The use of minimally invasive surgical techniques, such as those employing catheters or other elongate surgical probes, complicate this challenge by taking certain aspects of a given medical procedure beyond the normal field of view of the surgeon. For example, conventional minimally invasive techniques for placing a trocar or needle across the atrial septum of a heart involves pushing a transseptal needle, such as those sold by Medtronic/AVE under the tradename “Brockenbrough™”, out of a introducer sheath and across the atrial septum, with guidance provided by a conventional imaging modality, such as fluoroscopy.
While conventional techniques, such as “over-the-guidewire” techniques, enable approximate positioning of a transseptal needle adjacent a targeted location upon the atrial septum, there is still no assurance that the needle is correctly positioned before advancement through the tissue wall. Further, it is difficult ascertaining whether the tip of the transseptal device been advanced across the tissue wall and into an adjacent cavity, and whether the cavity is, in fact, the targeted cavity.
The invention is illustrated by way of example and is not limited to the embodiments in the figures of the accompanying drawings, in which like references indicate similar elements. Further, features shown in the drawings are not intended to be drawn to scale, nor are they intended to be shown in precise positional relationship.
In the following detailed description of embodiments of the invention, reference is made to the accompanying drawings in which like references indicate similar elements. The illustrative embodiments described herein are disclosed in sufficient detail to enable those skilled in the art to practice the invention. The following detailed description is therefore not to be taken in a limiting sense, and the scope of the invention is to be defined and limited only by the appended claims.
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The tubular member (126) also preferably comprises a substantially translucent polymeric material, such as polymethylmethacrylate (“PMMA”) or polyimide, paired appropriately with the imaging modality, to enable visualization into and across the tubular member (126) with the imaging element (108). The tubular member may comprise a separate tube component coupled to the distal end of the elongate tubular member (118) utilizing conventional techniques such as polymeric adhesive or stainless steel clips, or may comprise an extension of the material comprising the elongate tubular member (118).
The imaging element (108) may comprise a distal end of an optical fiber, in which case the depicted image transmission line (106) comprises an optical fiber, or it may comprise another image capturing element, such as a charge-coupled-device (CCD) or infrared imaging chip, in which case the image transmission line (106) may comprise an electronic data transmission wire. A lighting element (110) is paired with the imaging element to provide illumination or radiation appropriate for capturing images in the given tissue cavity. In the case of an optical fiber distal end as an imaging element (108), the lighting element (110) preferably comprises an emitter of light, such as a small light bulb, light emitting diode, or end of another optical fiber distal end in communication with an emitter or light. The light energy transmission line (112) may comprise optical fiber, electronic lead wire, or the like to transmit the appropriate lighting energy to the lighting element (110). In another embodiment, the lighting element (110) comprises an emitter of infrared-spectrum radiation and the imaging element (108) comprises an infrared-detecting imaging element to enable infrared-spectrum visualization within the geometrically prescribed field of view (114). Suitable infrared emitters and detectors are well known in the art and available from suppliers such as CardioOptics of Boulder, Colo.
The imaging element (108) may comprise a lens, filter, mirror, or other structure configured to control the field of view (114) or focal length of the associated imaging element (108). Further, a lens, filter, mirror, or other structure may be positioned distally from the imaging element (108) within the balloon portion (116) of the catheter distal end (100) for similar purposes. The utilization of a imaging element (108) located at the distal end of a medical instrument, such as a balloon catheter, for purposes of visualizing objects from the point of interest is referred to herein as “direct visualization”. In other words, “direct visualization” is used in reference to placing an imaging “eye” distally to the location of tissue treatment interest.
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The elongate tubular member (118) preferably comprises a conventional polymeric material, such as that sold under the trade name “Pebax™” by Atofina Corporation, which is suitable for use inside of animals and has desirable mechanical and manufacturing properties. In the case of optical fiber, glass fibers, such as those conventionally utilized in endoscopes, may be utilized, or more flexible polymeric optical fibers, such as those available from Nanoptics Corporation of Gainesville, Fla., may be utilized.
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As the contracted (130) balloon (102) approaches the substructures (310), a narrowed field of view (115) captured by the imaging element (108) as facilitated by the lighting element (110) may be utilized for navigating the balloon (102) into position adjacent the tissue wall (300). In a substantially nontranslucent media such as blood within the first cavity (302), visualization of the substructures or tissue wall may not be useful until the distal end of the balloon is very close to the tissue wall (300), whereas in a more translucent media, such as saline or carbon dioxide, targeted tissues and substructures may become visible as soon as they are within a direct field of view, depending upon the focal characteristics of the imaging element (108), as would be apparent to one skilled in the art. Further, the translucent media within the balloon (102) may comprise a contrast agent to facilitate imaging. For example, in the case of a conventional fluoroscopic imaging modality, the translucent media preferably comprises a conventional contrast agent such as iodine.
Upon entry into a relatively large cavity (302), the balloon may be inflated to provide a broadened field of view and illumination, as shown in
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Likewise, for flow rate, oxygen saturation, etcetera, as described in reference to
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A process similar to that of
Appropriate positioning of the working lumen (124) relative to the outlines of the fossa ovalis may be confirmed utilizing images from the imaging element (108) with a preferably fully expanded (128) balloon (102) urged against the atrial septum, subsequent to which a traversing member (312), such as a Brockenbrough™ needle, may be advanced into the atrial septal wall through the working lumen (124), as observed through the tubular member (126), and preferably also through redundant visualization modalities, such as ultrasound and/or fluoroscopy. Further, the traversing member (312) may be instrumented with such as a pressure, flow rate, color shade, or other sensor, to confirm that the distal tip of the traversing member (312) is indeed where the operator thinks it is.
Although the invention has been described herein with reference to specific embodiments, many modifications therein will readily occur to those of ordinary skill in the art without departing from the inventive concepts taught herein. Accordingly, all such variations and modifications are included within the intended scope of the invention as defined by the following claims.
Claims
1. (canceled)
2. A method for traversing a tissue wall in a body, comprising:
- endoluminally advancing a direct visualization elongate instrument into a first cavity opposite a tissue wall from a second cavity, wherein the elongate instrument comprises at its distal end an imaging element and a component configured to provide a substantially unobstructed field of view;
- approaching the tissue wall with the elongate instrument;
- adjusting the relative positioning between the distal end of the elongate instrument and the tissue wall based upon direct visualization feedback;
- engaging the tissue wall with the component, and providing a path to the tissue wall with the lumen of the elongate instrument extending through the component;
- controllably advancing a tissue traversing member out of the lumen of the elongate instrument, through the component, and through the tissue wall into the second cavity; and
- upon traversing the tissue wall, confirming a position of the traversing member in the second cavity using an imaging element or sensing element positioned in the second cavity;
3. The method of claim 2, wherein approaching the tissue wall comprises
- advancing the elongate instrument distal end to a position adjacent the tissue wall with the elongate instrument distal end in a contracted shape, and
- expanding the component into an expanded shape such that a distal face of the component is substantially normal to the longitudinal axis of the elongate instrument to facilitate a larger direct visualization field of view of the tissue wall.
4. The method of claim 2, wherein adjusting the relative positioning comprises capturing images with an imaging element positioned within an interior of the elongate instrument distal end, the images representing one or both of structures located immediately adjacent an exterior of the elongate instrument distal end within a field of view of the imaging element, and structures comprising the elongate instrument distal end within the field of view of the imaging element.
5. The method of claim 2, wherein engaging the tissue wall comprises advancing the elongate instrument toward the tissue wall until contact is observed in the direct visualization feedback.
6. The method of claim 5, wherein engaging the tissue wall further comprises ejecting saline between the elongate instrument distal end and the tissue wall to displace blood or other fluids in order to enhance visualization of the tissue wall.
7. The method of claim 2, wherein controllably advancing the tissue traversing member comprises observing a relative positioning of the tissue wall, the tissue traversing member, and the elongate instrument distal end with direct visualization feedback.
8. The method of claim 2, wherein controllably advancing the tissue traversing member comprises monitoring a variable selected from a group consisting of pressure, color, oxygen saturation, flow rate, and echo timing, in order to determine the position of the tissue traversing member relative to the tissue wall.
9. The method of claim 2, wherein the tissue wall is an atrial septum and approached from a right atrium, and wherein the tissue traversing member is controllably advanced through the atrial septum into a left atrium.
10. The method of claim 9, wherein adjusting the relative positioning comprises locating the position of a fossa ovalis upon the atrial septum.
11. The method of claim 2, where the traversing member further includes a piercing tip and a traversing lumen, where the traversing lumen provide access across the tissue wall after withdrawing the elongate instrument away from the tissue wall.
12. The method of claim 11, further comprising advancing tools through the traversing lumen.
13. The method of claim 2, wherein endoluminally advancing a direct visualization elongate instrument comprises intravascularly advancing a direct visualization elongate instrument.
14. The method of claim 2, wherein the component is a balloon.
15. A system to controllably traverse a tissue wall in a body, comprising:
- an elongate tubular member having a distal end and defining a working lumen;
- a component configured to provide a substantially unobstructed field, of view coupled to the distal end of the elongate tubular member, the component having a distal face and a proximal end, where, when expanded the distal face is substantially normal to the longitudinal axis of the working lumen;
- a first imaging element disposed in an interior of the component or at a distal end of the elongate tubular member or the component;
- a lighting element disposed in the interior of the component or at a distal end of the elongate tubular member or the component;
- a tubular element defining a lumen between the distal end of the component and a distal end of the working lumen of the elongate tubular member;
- a tissue traversing element configured to advance from a first cavity through and across a tissue wall into a second cavity, wherein the tissue traversing element is disposed within the working lumen of the elongate tubular member and positioned to slidably extend through the working lumen and tubular element lumen and beyond the component distal face within a field of view of the first imaging element;
- and a sensing element or second imaging element coupled to the tissue traversing member or to a sleeve surrounding the tissue traversing member and configured for detection in the second cavity to confirm a position of the traversing member or the sleeve in the second cavity.
16. The system of claim 15, wherein the elongate tubular member further defines at least one component sizing lumen to supply fluid to expand the component.
17. The system of claim 15, wherein the elongate tubular member further defines a lumen for transmitting light energy and image data between one or more external devices and the respective lighting and imaging elements.
18. The system of claim 15, wherein the first imaging element comprises a charge-coupled device.
19. The system of claim 15, wherein the first imaging element comprises an optical fiber.
20. The system of claim 15, wherein the lighting element comprises a structure selected from the group consisting of an incandescent light source, a light-emitting diode, and an optical fiber.
21. The system of claim 15, wherein the tissue traversing member carries the sensing element which is configured to monitor a variable selected from a group consisting of pressure, color, oxygen saturation, flow rate, and echo timing.
22. The system of claim 15, wherein the first imaging element is disposed adjacent the component proximal end.
23. The system of claim 15, wherein the first imaging element is disposed adjacent the component distal end.
24. The system of claim 23, wherein a field of view of the first imaging element does not include portions of the component.
25. The system of claim 15 wherein the distal end of the component forms a concave surface out of which a field of view of the first imaging element extends distally.
26. The system of claim 15, wherein the component is a balloon.
Type: Application
Filed: Apr 20, 2012
Publication Date: Nov 22, 2012
Applicant: HANSEN MEDICAL, INC. (Mountain View, CA)
Inventors: Daniel T. WALLACE (Burlingame, CA), Daniel T. ADAMS (Palo Alto, CA), Frederic H. MOLL (Woodside, CA), Gregory J. STAHLER (San Jose, CA)
Application Number: 13/452,029
International Classification: A61B 1/018 (20060101); A61B 1/07 (20060101); A61B 1/06 (20060101); A61B 1/05 (20060101); A61B 1/12 (20060101);