EP0751738A4

EP0751738A4 - Method and apparatus for performing hysteroscopic and falloposcopic procedures

Info

Publication number: EP0751738A4
Application number: EP95912793A
Authority: EP
Inventors: Julian N Nikolchev; Michelle M Arney; James Doty
Original assignee: Conceptus Inc
Current assignee: Bayer Essure Inc
Priority date: 1994-03-07
Filing date: 1995-03-06
Publication date: 1998-11-11
Also published as: JPH10500034A; WO1995024149A1; AU1983695A; EP0751738A1

Abstract

Imaging of a fallopian tube (F) is accomplished using a coaxial system comprising a hysteroscope (10), an access catheter (40), and a falloposcope (60). The access catheter (40) and falloposcope (60) are designed to permit proper alignment between their respective distal ends (45) in order to enhance image quality. A support system for the hysteroscope (10) is provided so that the hysteroscope need not be manually manipulated during the procedure.

Description

METHOD AND APPARATUS FOR PERFORMING HYSTEROSCOPIC AND FALLOPOSCOPIC PROCEDURES

BACKGROUND OP THE INVENTION 1. Field of the Invention

The present invention relates generally to endoscopic surgical methods and apparatus. More particularly, the present invention relates to an improved method and system for performing hysteroscopic and falloposcopic examination of the fallopian tubes and other elongate body ducts.

Diseases of the fallopian tubes are 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 tubes in a least invasive manner. Such difficulties, however, have been largely overcome by the present availability of very small guidewires, catheters, and fiberoptic viewing scopes, usually referred to as falloposcopes. Using such instruments and systems, a physician can gain atraumatic access to the interior of the fallopian tubes through a hysteroscopic positioned within the uterus. Such imaging techniques are described in Kerin et al. (1990) Fertil . Steril . 5_4:390-400 and J. Laparoendoscopic Surg. 1 :47-56.

Such falloposcopic access and imaging techniques are generally performed as follows. A hysteroscope is introduced into the uterus and an irrigating solution introduced to distend the uterus and permit video monitoring. A very small guidewire is then introduced through the hysteroscope and advanced past the os into the fallopian tube. The guidewire will continue to be advanced until it approaches the distal fimbria. A small access catheter may then be advanced through the hysteroscope and over the guidewire into the fallopian tube, again preferably reaching the distal fimbria. After removing the guidewire, the falloposcope, a small diameter fiberoptic bundle including both imaging and illumination fibers, 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 through the fallopian tube while producing an image on the associated video monitor. The access catheter also provides an access lumen for devices, such as drug delivery catheters, small instruments, and the like, for treatment of tubal lumen disease.

While such falloposcopic techniques represent a significant advantage, they still suffer from certain limitations. The techniques require simultaneous manipulation and coordination of the hysteroscope, access catheter, and falloposcope in order to introduce the falloposcope to the fallopian tube and withdraw the catheter and falloposcope for imaging. Such manipulation must be performed while the treating physician is viewing two separate images from the hysteroscope and falloposcope. Thus, such falloposcopic procedures have usually required at least one assistant to hold and manipulate the hysteroscope at the desired location throughout the procedure. The primary treating physician can then manipulate both the access catheter and falloposcope in order to produce images of the desired region. Manipulation of the catheter and falloposcope by themselves, however, can be problematic.

A particular problem that can arise results from elongation associated with stretching of the access catheter as the catheter and falloposcope are drawn through the fallopian tube in a retrograde manner. Because of resistance to passage of the catheter through the fallopian tube, the catheter can be stretched so that its distal end elongates past the distal end of the falloposcope. Optimal imaging occurs when the distal end of the falloposcope is substantially aligned with the distal end of the access catheter. Thus, it may become necessary for the physician to periodically stop the procedure, unattach the falloposcope from the access catheter, and reposition the falloposcope relative to the catheter so that image sharpness is restored.

An additional problem can arise when the guidewire and/or access catheter are introduced from the hysteroscope through the os into the fallopian tube. The guidewire and falloposcope can encounter resistance which requires increased force on the guidewire or catheter in order to continue advancement. Heretofore, most hysteroscopes have had flexible working shafts which are steerable over at least their distal portions. Directing the distal end of the working shaft facilitates aiming of the guidewire and catheter through the os, but the flexible working shaft can often yield or deflect when the guidewire or catheter are being vigorously pushed to overcome resistance to advancement. Such deflection of the working shaft can cause the catheter to back out of the os rather than advance through it.

Further shortcomings of present hysteroscopic and falloposcopic techniques include back leakage of irrigation fluid around the shaft of the hysteroscope where it enters through the cervical os, breakage of the relatively fragile falloposcope (particularly where it enters the hysteroscope) , and lack of positional information on the falloposcope within the hysteroscope (it is difficult to tell when the distal tip of the falloposcope is approaching the distal end of the access catheter) .

It would therefore be desirable to provide improved methods and systems for introducing guidewires, catheters, falloposcopes, and other instruments into the fallopian tubes for diagnosis and treatment. It would be particularly desirable to provide methods and systems to facilitate manipulation of the hysteroscope, guidewire, access catheter, falloposcope, and other instruments which are to be introduced. Such methods and systems should reduce the number of hands and preferably the number of people required to manipulate and coordinate the various components of the system. Additionally, it would be desirable to provide improved hysteroscopes which define a more stable base or platform for introducing guidewires, catheters, and other devices, through the os and obstructions within the fallopian tubes. Moreover, it would be desirable to provide improved access catheters and falloposcopes which facilitate alignment of the falloposcope with the access catheter as the system is withdrawn in a retrograde manner through the fallopian tube for imaging.

2. Description of the Background Art Kerin et al. (1990) Fertil . Steril.54.:390-400 and J.

Laparoendoscopic Surg . 1 :47-56 have been described above.

Kerin et al. (1992) Fertil . Steril.57:731-741 and Kerin and

Surrey (1992) Clin . Obstet . Gγnecol.35:299-312 describe diagnostic and treatment procedures that can be performed falloposcopically. A microcatheter having variable flexibility along its length is described in U.S. Patent No. 4,739,768.

Hysteroscopes and falloposcopes are described generally in U.S.

Patent Nos. 4,911,148; 4,836,189; 4,779,612; 4,641,634; and

4,503,843. An articulated arm structure for supporting a laparoscope during surgical procedures is described in Munro

(1993) J. Am . Assn . Gynecol . Laparosc . l :67-70.

SUMMARY OF THE INVENTION

According to the present invention, methods, apparatus, and systems, are provided for accessing and imaging a patient's body lumen, particularly a fallopian tube, in a minimally or non-invasive manner. The present invention provides simplified apparatus and procedures for introducing and manipulating hysteroscopes, access catheters, falloposcopes, and other instruments for use in imaging and treatment of fallopian tubes. As a result of the present invention, fewer hands and fewer physicians may be required to perform such procedures, in many cases reducing the time, complexity, and cost, of such procedures. The apparatus and procedures of the present invention further provide for improved image quality when the fallopian tube is imaged using a catheter and falloposcope passed through the tube in a retrograde manner. These and other advantages of the present invention will be more apparent in the detailed description of the invention which follows.

In a first aspect of the present invention, an access catheter is introduced to the fallopian tube through a viewing scope, typically a hysteroscope, which provides a primary access lumen. The proximal end of the viewing scope is fixed onto a support surface, and the access catheter introduced through the working lumen of the viewing scope (typically over a guidewire) while the viewing scope remains immobilized. In this way, after the viewing scope has been immobilized, the treating physician is free to use his or her hands to perform introduction of the access catheter and other tasks required for imaging or treatment. Immobilization of the viewing scope may be accomplished using a support structure, such as an articulated arm, which is attached to the support surface at one end and to the proximal end of the viewing scope at its other end. Imaging may then be performed by introducing a fiberoptic imaging element through the access catheter into the fallopian tube, as described in more detail below. In a second aspect of the present invention, a support structure for the viewing scope comprises an arm structure having a first end and a second end with a plurality of articulated segments therebetween. A clamp or other attachment device is provided at a first end of the support structure for mounting the arm on a fixed surface, and an attachment member is provided on the other end of the arm for detachably securing a proximal handle of a viewing scope. Means are further provided for selectively immobilizing the articulated segments so that the distal end of the arm structure may be locked relative to the proximal end to hold the viewing scope in the desired orientation. A preferred clamp for the viewing scope comprises an elongated base having an axial slit with a pair of opposed retaining elements disposed on either side of the slit. The slit may then be tightened to clamp the proximal handle of the hysteroscope therebetween.

In a third aspect of the present invention, an access catheter is introduced to a patient's fallopian tube by introducing the shaft of the viewing scope in the uterus. A distal portion of the shaft having a length from 1 cm to 4 cm is then deflected toward the os of the fallopian tube which is desired to be entered. The remainder of the shaft of the viewing scope remains substantially rigid while the guidewire is first introduced through the os and into the fallopian tube. The access lumen is then advanced over the guidewire while the rigid portion of the shaft provides support to assist advancement of the catheter into the fallopian tube. In a fourth aspect of the present invention, an improved hysteroscope comprises a handle and deflectable working shaft having an access lumen and fiberoptic imaging elements therein. The improvement comprises a working shaft which is substantially rigid over its proximal length and selectively deflectable over from 1 cm to 4 cm of its distal length. In this way, the hysteroscope can be used for introducing a guidewire and access catheter into the fallopian tubes as described above. The improved hysteroscope may further comprise an enlarged diameter shoulder on the working shaft which is located from 3 cm to 12 cm proximally of the distal end of the shaft. The diameter of the working shaft is preferably 4 mm or less, to facilitate introduction through the cervical os into the uterus. The shoulder preferably has a diameter from 4 mm to 5 mm to enhance sealing against the cervical os to prevent the loss of fluid when the uterus is distended with a clear irrigation solution for viewing.

In a fifth aspect of the present invention, an improved method for retrograde imaging of an elongate body duct comprises withdrawing a fiberoptic imaging element disposed within an access catheter through the lumen. The improvement comprises adjusting the position of the imaging element within the access catheter as the element is withdrawn in order to maintain alignment of the distal end of the imaging element with the distal end of the access catheter. In this way, the elongation of the access catheter which may occur during withdrawal of the catheter and imaging element can be offset and image quality can be enhanced. Usually, the relative position of the imaging element in the access catheter will be adjusted manually, where the user manually grasps the proximal ends of both the access catheter and the imaging element. The user may thus continuously adjust the relative positions of the imaging element and access catheter in order to maintain the desired image quality. In a sixth aspect of the present invention, a system for imaging a tubular duct comprises a remote access catheter having a hub at its proximal end. A fiberoptic imaging element is receivable through a port in the hub and within a central lumen of the access catheter. The imaging element has a length which is greater than that of the catheter lumen and includes a sleeve formed thereover and positioned so that the sleeve will be disposed within the first hub port when the distal end of the imaging element is aligned with the distal end of the catheter. The hub port and sleeve are adapted so that the port may be closed over the sleeve with sufficient tightness to prevent leakage of fluid as the duct is being distended with pressurized fluid while still allowing the fiberoptic element to be axially translated within the access catheter. Preferably, the access catheter has a reduced diameter over a distal portion thereof, usually having a distal portion with a length in the range from 4 cm to 20 cm and an inner diameter in the range from 0.4 mm to 0.6 mm and a proximal portion with a length greater than or equal to 25 cm and an inner diameter in the range from 0.6 mm to 1 mm. The hub includes a valve for selectively tightening over the sleeve.

A further understanding of the nature and advantages of the invention will become apparent by reference to the remaining portions of the specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a side elevational view of a hysteroscope constructed in accordance with the principles of the present invention. Fig. 2 is a top view of the hysteroscope of Fig. 1.

Fig. 3 is an enlarged end view of the working shaft of the hysteroscope of Fig. 1, taken at line 3-3.

Fig. 4 is a perspective view of the combination of an access catheter and falloposcope constructed in accordance with the principals of the present invention.

Fig. 5 is an elevational view of the falloposcope of Fig. 4, illustrating the entire assembly. Fig. 6 is an enlarged end view of the falloposcope of Fig. 5, taken at line 6-6.

Fig. 7 illustrates the combination of hysteroscope, access catheter, and falloposcope used in imaging a fallopian tube through the uterus.

Fig. 8 is a detailed view of a proximal hub on the access catheter showing the position of a control sleeve on the falloposcope within a port on the hub.

Fig. 9 illustrates the preferred method for holding the proximal end of the hysteroscope in the method of the present invention, where the proximal end is immobilized and a support structure attached to a table.

Figs. 10-13 illustrate the use of the access catheter and falloposcope in imaging a fallopian tube in greater detail.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS The present invention utilizes a viewing scope to provide a primary access lumen into a patient's body cavity, typically the uterus. The viewing scope will have viewing capabilities, typically in the form of a fiberoptic bundle running through its working shaft. The working shaft will also provide the access lumen, and the scope will typically include a proximal handle which provides a port which opens into the access lumen and the necessary interface between the fiberoptic bundle and the external video imaging equipment. In the exemplary embodiment, the viewing scope will be a hysteroscope having a substantially rigid working shaft with a deflectable distal tip, as described in more detail hereinafter. It will be appreciated, of course, that the term hysteroscope is used for convenience only, and the present invention can utilize any viewing scope having the requisite capabilities just described.

Referring now to Figs. 1-3, a viewing scope 10 comprises a working shaft 12 having a proximal end 14 and distal end 16 and a handle 18 attached at its proximal end. An access or working lumen 20 extends from the proximal end 14 to the distal end 16 of shaft 12 and is accessible through a connector port 22 disposed on the handle 18. The working shaft 12 further includes a fiberoptic bundle 24 (Fig. 3) and a plurality of illuminating optical fibers 26 which may be interfaced with conventional video monitoring equipment through connecting cables 28 and 30.

As described thus far, the construction of the viewing scope is generally conventional and typical of a variety of commercially available hysteroscopes such as those available from Olympus Optical Company, Intramed Laboratories, Inc., and others, and described in U.S. Patent Nos. 4,911,148; 4,836,189; 4,779,612; 4,641,634; and 4,503,843, the full disclosures of which are incorporated herein by reference. The present invention provides improved viewing scopes, particularly in the form of improved hysteroscopes, where the working shaft is modified in two respects to enhance and facilitate the introduction of guidewires, access catheters, and secondary fiberoptic imaging elements (e.g. falloposcopes) from the uterus into a fallopian tube. The first improvement comprises forming the working shaft as a substantially rigid structure from the proximal end 14 to a transition point 30. The remainder of the working shaft 12 will be deflectable from the transition point 30 to the distal tip 16. In the illustrated embodiment, the tip can be deflected in a right direction or left direction, as illustrated in broken line in Fig. 2, using knob 32 on handle 18. The length of the deflectable portion of shaft 12 will be in the range from 1 cm to 4 cm, preferably being from 2 cm to 3 cm. Total length of the working shaft 12 will be in the range from 15 cm to 25 cm, preferably from 17.5 cm to 18.5 cm.

The second improvement in working shaft 12 is the provision of a tapered shoulder 34 at a location between the proximal end 14 and distal end 16. The tapered shoulder 34 is intended to engage and seal the cervical os OS, as illustrated in Fig. 7, when the working shaft 12 is introduced to the uterus. The shoulder will be located by distance in the range from 3 cm to 12 cm, preferably from 10 cm to 12 cm, from the distal end 16 of the shaft. The diameter Dl of the shaft distal to the shoulder 34 will usually be below 4 mm, preferably being in the range from 3.5 to 3.6 mm. The diameter D2 of the proximal of the shaft is less critical, typically being in the range from 4 mm to 5 mm. The access lumen 20 through the working shaft 12 may also have a stepped diameter corresponding to the outer diameter but this is not necessary. The diameter of lumen 20 will typically be in the range from 1 mm to 2 mm, preferably from 1.5 mm to 1.7 mm

Access to the target body lumen, typically a fallopian tube, will be provided through the working lumen 20 of the viewing scope 10 using a small-diameter access catheter The length of the catheter will be sufficient to permit introduction through the viewing scope and into the target lumen. In the case of the fallopian tube, the length of the body of the access catheter will typically be from 40 cm to 60 cm, usually being about 50 cm. Suitable catheters may be constructed in accordance with the teachings of U.S. Patent 4,739,768, the full disclosure of which is incorporated herewith by reference.

A particular catheter 40 for use in the systems and methods of the present invention is illustrated in Figs. 4 and 8. The catheter 40 includes a catheter body 42 having a distal portion 44, a distal port 45, and a proximal end 46. The distal portion 44 will preferably have a reduced diameter compared to the proximal portion. Usually, the distal portion will have an inner diameter in the range from 0.4 mm to 0.6 mm, preferably from 0.5 mm to 0.6 mm, usually being about 0.55 mm. The proximal portion will have an inner diameter in the range from 0.6 mm to 1 mm, preferably from 0.6 mm to 0.75 mm, usually being about 0.68. The length of the reduced-diameter distal portion 44 will typically be from 4 cm to 20 cm, preferably from 15 cm to 20 cm, more usually being about 17 to 18 cm. Such a bifurcated construction has the advantage of a smaller distal end to facilitate entry into the fallopian tube, as discussed in more detail below, and a larger proximal portion to reduce flow resistance when introducing fluid to distend the fallopian tubes, also as discussed in more detail hereinbelow. Catheter 40 further includes a proximal connector 50 which includes an axially aligned port 52 and a side port 54. The axially aligned port 52 receives a fiberoptic imaging element 60 (illustrated in isolation in Figs. 5 and 6) , while the side port 54 remains available for introducing irrigation fluid through the lumen of catheter body 42 into the fallopian tube, as described hereinafter.

Fiberoptic imaging elements 60 is typically in the form of a falloposcope comprising flexible shaft 62 a small diameter, typically in the range in the range from 0.3 mm to 0.6 mm, usually about 0.5 mm. The shaft 67 carries a fiberoptic bundle 64 and a plurality of light transmitting optical fibers 66 at the distal end 68 for imaging and illuminating, respectively (Fig. 6) . The fiberoptic imaging element 60 further includes a pair of connectors 70 and 72 attached to proximal end 74 by a flexible cable 76. Connectors 70 and 72 allow interconnection with conventional video monitoring equipment, where one connector provides the visual image and the other connector provides the illumination.

The fiberoptic imaging element 60 is configured to mate with the access catheter 40 in a way that facilitates manipulating both the imaging element and catheter during imaging of the fallopian tube. In particular, the length of the flexible shaft 62 (including a control sleeve section 80 described below) will be slightly longer than the total length of the access catheter 40 from its distal tip to the axially aligned port 52. Typically, flexible shaft will be from 1 cm to 10 cm longer than the catheter 40, having a total length from 55 cm to 65 cm.

The fiberoptic imaging element 60 further includes a control sleeve 80, typically in the form of a polymeric sheath, formed over a proximal portion of the flexible shaft 62. The control sleeve 80 will be sized to be received within axially aligned port 52, more particularly to be received within a compression-seal valve 82 disposed in the port. Usually, the control sleeve will have a diameter in the range from 1.5 mm to 2 mm, preferably from 1.6 mm to 1.7 mm. The compression seal valve 82 will typically be a Touhy-Borst valve or equivalent which permits the physician to selectively tighten an O-ring 82 on the exterior of the control sleeve 80. The enlarged diameter of the control sleeve 80 relative to the shaft 62 greatly facilitates forming a compression seal (i.e., it is very difficult to seal around the shaft 62 of the imaging element 60 which typically has a diameter of about 0.5 mm. The control sleeve also provides strain relief which helps protect the delicate imaging element. By tightening the valve in an appropriate amount, leak-back of irrigation fluid introduced through side port 54 is prevented without significantly inhibiting axial translation of the sleeve within the valve. This is an important feature since it allows the physician to adjust the relative position of the fiberoptic imaging element 60 within the catheter 40 in order to maintain alignment of their respective distal ends in order to enhance imaging with interrupting imaging of the fallopian tube. Conveniently, a connector 88 is provided on the imaging element 60 on the proximal side of control sleeve 60. Connector 88 allows the physician to grasp and manipulate the imaging element 60 by holding both the connector 88 and the proximal connector 50 on the catheter 40 and pushing or pulling as appropriate. The physician may use either two hands or a single hand to perform such manipulations. Referring now to Figs. 7 and 10-13, use of the viewing scope 10, access catheter 40, and fiberoptic imaging element 60 in the imaging of a fallopian tube F will be described. The working shaft 12 of the hysteroscope 10 is first introduced to the uterus U in a conventional manner or using an adjustable support system as described hereinafter. The deflectable distal end 16 of the shaft 12 is directed toward the os OS and a guidewire (not illustrated) introduced through a Y-connector 90 affixed to the connector 22 on the scope 10. The uterus will be distended by introducing irrigation fluid through side port 92 on connector 90 so that the guidewire may be introduced under direct visualization through the scope. The physician may also view the procedure fluoroscopically. Suitable guidewires are available from commercial suppliers, such as Target Therapeutics, Fremont, California, and others. Typically, the guidewire will be introduced at least 1 cm beyond the tubal os, and preferably to near the distal fimbria F. After the guidewire has been properly located, access catheter 40 will be introduced over the guidewire, again in the conventional manner. The catheter 40 will preferably be introduced until its distal end 44 approaches the fimbria F, as illustrated in Fig. 7. The guidewire may then be withdrawn and exchanged for the fiberoptic imaging element 60, which will be introduced so that distal end 68 becomes aligned within distal port 45 end of the catheter 40.

In order to distend the fallopian tube and permit imaging, a clear irrigation fluid is introduced through the side connector 54 on hub 50. Because of leakage through the fimbria, it is necessary to introduce the fluid at a rate from about 5 ml/min to 10 ml/min. Use of the catheter 40 having an enlarged proximal portion has been found to significantly reduce the pressure required to introduce fluid at such rates. While a catheter having a uniform diameter (size so that its distal portion may pass through the fallopian tube) may require a pressure up to 10 atm or higher, use of an enlarged proximal diameter (as described above) can reduce the pressure below 5 atm, of 3 to 5 atm. Such reduced pressure are easier to handle and decrease the likelihood of accidents.

After the clear irrigation fluid has opened the field of view, the imaging element 60 and catheter 40 are withdrawn simultaneously in a retrograde manner to provide imaging along the length of the fallopian tube. In order to obtain clear images, it is important that the distal end 68 of the imaging element 60 be maintained just at the proximal port 45 of the catheter 40, as illustrated in Fig. 10. If the distal end 68 of the imaging element 60 is withdrawn inside of the lumen of catheter 40 (Fig. 11) , the field of imaging is restricted. If the distal end extends outside of the lumen, the tip of the imaging element 60 is subjected to damage and inadequately irrigated by fluid leaving the distal port 45 of the access catheter. As the combination of access catheter 40 and imaging element 60 continue to be withdrawn through the fallopian tube F, the catheter body 42 will have tendency to elongate so that its distal end 45 extends beyond distal end 68 of the imaging element, as illustrated in Fig. 11. As described above, such a situation degrades the image quality being provided. Using the system of the present invention, image quality can readily be restored by adjusting the axial position of the imaging element 60 within the catheter 40 by translating control sleeve 80 within the axial port 52 of connector 50. In particular, the physician can continuously move the connector 88 relative to connector 50 while viewing the image on the associated video monitor in order to obtain the clearest image possible as the catheter is being withdrawn through the fallopian tube. In this way, the distal end 68 of imaging element 60 can be maintained in alignment with the distal port 45 of catheter 40 as the catheter and imaging element are being withdrawn, as illustrated in Figs. 12 and 13. In order to further simplify the procedures of the present invention, methods and apparatus have been developed for immobilizing the viewing scope 10 on a table T or other surface after the scope has been properly positioned in the uterus. Referring to Fig. 9, support structure 100 includes a plurality of arms 102 and joints 104 which are designed to freely articulate so that a support base 106 at a distal end of the structure 100 can be moved freely in space (until locked in position using the central knob 105) . Preferably, the support structure 100 may be firmly secured to a table leg L using a clamp 110 and attachment structure 112. Such systems are commercially available from suppliers, such as Lino Manfrotto & Company.

The present invention provides a unique support base 106 and scope attachment member 120. The base 106 is attached to the support structure and may be locked in position together with all remaining components of the support structure. The scope attachment member 120 may be mounted on the support 106 using a quick interconnect mechanism 122. The attachment member comprises a pair of opposed retaining elements 130 which are separated by an axial slit 132. A threaded shaft 134 or other tightening mechanism is provided so that the retaining elements may be secured on opposite sides of the handle 18 of the viewing scope 10. In this way, attachment member 120 may be secured to the handle 18 prior to the mounting of the attachment member and handle onto the support structure 100 using the disconnect 122.

Using the support structure 100 and improved access catheter 40 and imaging element 60 of the present invention, fallopian tube imaging procedures can be easily performed by a single physician. The physician can first introduce the viewing scope 10 into the uterus and identify the target fallopian tube ostium. The scope 10 can then be attached to the support structure 100 and the support structure locked in position (immobilized) when the scope is in its desired position. Thus, the scope will be held in a rigid and fixed position without the need for an assistant to hold it. The physician can then introduce the catheter 40 and imaging element 60 using the guidewire procedure described above while the viewing scope 10 remains locked in position on the support structure 100. Once the access catheter 40 is in place, the catheter and imaging element 60 may be withdrawn in a retrograde manner through the fallopian tube to perform the imaging, as described above.

Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.

Claims

WHAT IS CLAIMED IS;

1. A support structure for a viewing scope, said support structure comprising: an arm structure having a first end and a second end with a plurality of articulated segments therebetween; means on the arm structure for selectively immobilizing the articulated segments; a clamp at the first end of the arm structure for mounting the arm on a fixed surface; and an attachment on the second end of the arm structure for detachably securing a proximal handle of a viewing scope.

2. A support structure as in claim 1, wherein the clamp comprises an elongate base having an axial slit, a pair of opposed retaining elements disposed across the slit, and means for tightening the slit to clamp a hysteroscope between the retaining elements.

3. A system for imaging a tubular duct, said system comprising: a remote access catheter having a proximal end, a distal end, and a lumen therethrough; a hub on the proximal end of the catheter and having at least a first port which opens into the lumen; a fiberoptic imaging element receivable within the catheter lumen and having a proximal end, a distal end, and a length greater than the catheter lumen; and a sleeve formed over the fiberoptic imaging element and positioned so that the sleeve will be disposed within the first hub port when the distal end of the imaging element is aligned with the distal end of the catheter.

4. A system as in claim 3, wherein the catheter comprises a distal portion having a length in the range from 4 cm to 20 cm and an inner lumen diameter in the range from 0.4 mm to 0.6 mm and a proximal portion having a length greater than or equal to 25 cm and an inner diameter in the range from 0.6 mm to 1 mm.

5. A system as in claim 4, wherein the hub has at least a second port which opens into the lumen to permit perfusion.

6. A system as in claim 5, wherein the hub includes a valve for selectively tightening over the sleeve on the fiberoptic imaging element so that the first port can be closed to inhibit fluid loss while permitting axial movement of the sleeve relative to the hub.

7. A system as in claim 6, further comprising a hub disposed over fiberoptic imaging element at a location proximal of the sleeve, whereby the hub can be used to manually translate the imaging element relative to the catheter.

8. A system as in claim 7, wherein the distal end of the hub is located at a distance proximal of the distal tip of the imaging element, which distance is from 1 cm to 10 cm longer than the total length of the access catheter and hub, whereby the imaging element and access catheter may be translated relative to each other in order to maintain alignment of their respective distal ends.

9. An improved hysteroscope of the type comprising a control handle and a deflectable working shaft having an access lumen and a fiberoptic imaging element, wherein the improvement comprises a working shaft which is substantially rigid over its proximal length and deflectable over from 1 cm to 4 cm of its distal length.

10. An improved hysteroscope as in claim 9, wherein the improvement further comprises an enlarged diameter shoulder on the working shaft located from 3 cm to 12 cm proximally of the distal and which shoulder will seal against the cervical os when the distal portion of the working shaft is positioned within the uterus and, wherein the distal portion of the working shaft has a diameter of 4 mm or less and a length in the range from 3 cm to 12 cm and wherein the diameter of the shoulder is from 4 mm to 5 mm.

11. A method for introducing an access catheter to a patient's fallopian tube, said method comprising: manually positioning a viewing scope to provide a primary access lumen into the patient's uterus; immobilizing a proximal end of the viewing scope on a fixed support surface; and introducing the access catheter through the primary access lumen of the immobilized viewing scope to provide a secondary access lumen into the fallopian tube.

12. A method as in claim 11, wherein the immobilizing step comprises clamping the proximal end of the viewing scope to a support structure attached to the support surface.

13. A method as in claim 12, wherein the support structure is an articulated arm which is clamped to the proximal end and immobilized after the viewing scope has been positioned in the uterus.

14. A method as in claim 12, wherein the support structure is an articulated arm which is clamped to the proximal end before positioning of the viewing scope within the uterus and immobilized after such positioning.

15. A method as in claim 12, further comprising axially translating the proximal end of the viewing scope relative to the support structure.

16. A method as in claim 11, further comprising introducing a fiberoptic imaging element through the secondary access lumen into the fallopian tube. 17. A method as in claim 16, further comprising axially translating the imaging element within the secondary access lumen to maintain alignment of the distal and of the imaging element with the distal end of the access catheter.

18. A method for introducing an access catheter to a patient's fallopian tube, said method comprising: introducing the shaft of a viewing scope into the uterus; deflecting a distal portion of the shaft having a length from 1 cm to 4 cm towards the os of the fallopian tube while the remainder of the shaft remains substantially rigid, introducing a guidewire through the os into the fallopian tube while the rigid portion of the shaft provides support for the guidewire; and introducing the access catheter over the guidewire while the rigid portion of the shaft provides support for the catheter.

19. A method as in claim 18, further comprising positioning an enlarged shoulder on the shaft of the viewing scope against the cervical os to seal the uterus and introducing fluid into the uterus to distend the uterus, whereby fluid loss is inhibited by the shoulder seal.

20. A method as in claim 18, wherein the deflectable distal portion of the shaft has a length in the range from 1 cm to 4 cm.

21. An improved method for retrograde imaging on elongate body duct of the type wherein a fiberoptic imaging element disposed within an access catheter is withdrawn through the lumen as the lumen is imaged through the imaging element, wherein the improvement comprises adjusting the position of the imaging element within the access catheter as the element is withdrawn in order to maintain alignment of a distal end of the imaging element with a distal end of the access catheter. 22. A method as in claim 21, wherein the position of the fiberoptic imaging element is adjusted manually.

23. A method as in claim 22, wherein a user manually grasps the proximal ends of both the access catheter and the imaging element and pulls on said ends to withdraw them through the body duct, wherein the relative positions are adjusted by pulling each back at different rates.