Surgery – Endoscope – With guide means for body insertion
Reexamination Certificate
1998-12-30
2001-03-06
Leubecker, John P. (Department: 3739)
Surgery
Endoscope
With guide means for body insertion
C600S127000, C600S104000, C604S286000
Reexamination Certificate
active
06196966
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to endoscopic surgical methods and apparatus. More particularly, the present invention provides an access catheter having a distally protruding structure which maintains separation between a viewing scope and a lumenal wall.
Diseases of the fallopian tubes are a major cause of infertility and tubal pregnancy. Until recently, diagnosis and treatment of tubal disease has been hampered by the difficulty in accessing and imaging the interior of the fallopian tube. Such difficulties, however, have been largely overcome by the recent availability of very small guidewires, catheters, and fiberoptic viewing scopes, usually referred to as falloposcopes. Using these instruments and systems, a physician can gain atraumatic access to the interior of the fallopian tube through a hysteroscope positioned within the uterus. Such falloposcopic imaging techniques were described by Kerin et al. in Fertil. Steril., Vol. 54, pp. 390-400 (1990), and in J. Laparoendoscopic Surg., Vol. 1, pp. 47-56.
Falloposcopic access and imaging techniques are generally performed as follows. A hysteroscope is positioned within the uterus and an irrigating solution is introduced to distend the uterus and permit video monitoring. A very small guidewire is then introduced through the hysteroscope and advanced past the ostium and into the fallopian tube. The guidewire will continue to be advanced until it approaches the distal fimbria. A small tubular access catheter may then be advanced through the hysteroscope and over the guidewire into the fallopian tube, again preferably approaching the distal fimbria. After removing the guidewire, the falloposcope (which is a small diameter fiberoptic bundling including both imaging and illumination fibers in a single shaft) is advanced until its distal end reaches the distal end of the access catheter. Imaging may then be performed in a retrograde manner with the falloposcope and access catheter being drawn outwardly together through the fallopian tube while producing an image on the associated video monitor. The lumen of the tubular access catheter will also provide an access path for devices, such as drug delivery catheters, small instruments, and the like, for treatment of tubal lumen disease.
While such retrograde falloposcopic imaging techniques represent a significant improvement, they still suffer from certain limitations. In particular, falloposcopes having both illumination and imaging fiberoptics require a minimum separation between the imaging lens at the end of the fiberoptic bundles and the tissue to be imaged. Unfortunately, the narrowly confined lumen of the fallopian tube contracts soon after the access catheter has been withdrawn. Hence, the tubal wall often collapses in on the withdrawing falloposcope during retrograde imaging, intruding upon the required imaging separation. As the tubal wall tissues come in close proximity with the imaging and illumination fiberoptics, excessive illumination light is reflected back to the imaging system, causing a partial or total “white-out” of the viewing monitor. These white-outs are a common and undesirable limitation on the effectiveness of retrograde imaging of the fallopian tube and other narrow body lumens.
It would therefore be desirable to provide improved methods and systems for imaging fallopian tubes and other narrow body lumens. It would be particularly desirable to provide improved access catheters and methods for their use which would reduce the incidence of white-out associated with the fallopian tubal wall approaching too close to the optical viewing scope. It would further be desirable if such improved methods and devices were compatible with and able to enhance the effectiveness of retrograde tubal imaging systems and methods.
It would also be desirable to provide improved imaging access methods, devices, and systems for use in the fallopian tubes and other body lumens. It would be particularly advantageous to provide simplified, atraumatic imaging methods and systems which would reduce the time and complexity of known fallopian tube accessing and imaging techniques, and which would provide reliable, high quality images of tubal walls to assist in the diagnosis and therapy of tubal disease.
2. Description of the Background Art
Kerin et al., Fertil. Steril., Vol. 54, pp. 390-400 (1990), and in J. Laparoendoscopic Surg., Vol. 1, pp. 47-56, have been described above. U.S. Pat. No. 4,793,326 describes an industrial endoscope having an elongated arm member to facilitate advancing separate illumination and observation windows past the abrupt steps of piping elbow joints. U.S. Pat. No. 4,717,387 describes an intercardiac catheter having a distal balloon for positioning the catheter with respect to a body surface to be viewed through an optical scope. U.S. Pat. No. 5,263,982 describes an endoscopic catheter having a laterally offset movable guidewire.
U.S. Pat. Nos. 5,047,848 and 4,825,259 disclose baroscope having specialized distal tip gauges which permit optical measurements of imaged features. U.S. Pat. No. 4,608,965 discloses an endoscopic sheath having a Malecott-type structure for anchoring the scope in a body cavity.
U.S. Pat. No. 5,358,496 is representative of numerous instruments intended to be inserted through endoscopes. U.S. Pat. Nos. 3,866,601; 4,306,566; 4,350,147; 4,846,812; 5,099,827; 5,263,928; 5,279,596; 5,306,261; 5,307,814; 5,308,342; 5,385,152; are also relevant.
An exemplary falloposcopic imaging system is described in co-pending application Ser. No. 08/207,475, filed Mar. 7, 1994, now abandoned, the full disclosure of which is incorporated herein by reference.
SUMMARY OF THE INVENTION
In a first aspect, the present invention provides a method for viewing a lumenal wall of a narrow body lumen. The method of the present invention comprises introducing a catheter within a body lumen and positioning an optical viewing scope within a lumen of the catheter so that a distal end of the scope is at a scope viewing position adjacent to a distal end of the catheter. A spacing structure is positioned between the lumenal wall and the distal end of the scope maintains separation between the lumen wall and the scope. The lumenal wall is imaged through the scope while the spacing structure maintains separation between the distal end of the scope and the lumenal wall. This separation helps prevent imaging white-out conditions which might otherwise occur when the optical viewing scope and body lumen wall are in close proximity. Although the spacing structure will typically appear in the viewing monitor, blocking some portion of the lumen wall from imaging, the image quality and availability are substantially enhanced. Preferably, the catheter is advanced distally of a target region of the body lumen during the introducing step, and the catheter and scope are proximally withdrawn while imaging through the distally oriented scope. This is generally referred to as “retrograde imaging.”
In some embodiments, the imaging step comprises viewing the lumen wall at least in part through a cage disposed over the distal end of the scope. Alternatively, the spacing structure may comprise a guidewire which extends distally from the catheter, which guidewire may also be rotated during introduction of the catheter to maneuver the catheter through a body lumen system. Alternatively, the spacing structure may comprise a wire loop extending distally from the catheter body. Such a wire loop may be expanded by advancing a proximal length of the wire relative to the proximal end of the catheter. In this way, the size of the loop can be adjusted maintain separation between the body lumen wall and the optical viewing position.
In another aspect, the present invention provides an improved method for viewing a target region of a fallopian tube. The method is of the type including transcervically accessing the fallopian tube with the catheter and inserting an optical viewing scope within a lumen of the catheter so that distal ends of the sco
Doty James
Hill Richard
Kerin John
Kramer Tom
Milo Charles
Bains, Esq. Nena
Conceptus, Inc.
Leubecker John P.
Townsend & Townsend & Crew LLP
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