Vibrating endoscopic catheter for tubal advancement

Abstract

To provide a vibrating endoscopic catheter for suitable tubal advancement.SOLUTION: A falloposcope intended for use with a hysteroscope to access a patient's fallopian tube, image the fallopian tube, and collect a sample from the fallopian tube includes a cannula having an angled tip oriented to engage the ostium of the fallopian tube when the cannula is trans-cervically introduced into the uterus of the patient through the hysteroscope. The catheter has a distal viewing tip configured to be advanced from the distal end of the cannula through the cervical os and into the uterus of the patient. The viewing chamber has a wide proximal end that is attached to the distal viewing tip of the catheter, and the viewing chamber is at least partially transparent and typically tapers distally in order to provide a clear viewing area for the endoscope as well as atraumatic advancement into the fallopian tube.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a continuation-in-part of, and claims the benefit of, U.S. Application No. 16 / 882,971, filed May 26, 2020 (Attorney Docket No. 58840-703.201), which also claims the benefit of U.S. Provisional Application No. 63 / 105,801, filed October 26, 2020 (Attorney Docket No. 58840-703.101), and U.S. Provisional Application No. 63 / 115,776, filed November 19, 2020 (Attorney Docket No. 58840-703.102), the contents of each of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE INVENTION The present invention relates generally to devices and methods for endoscopic intrauterine fallopian tube access and advancement, and more particularly to a vibrating, transparent, tapered-tipped endoscopic device employing force limiting, which can be advanced to advance the length of the fallopian tube. [Background technology]

[0003] BACKGROUND OF THE INVENTION For the purpose of tubal recanalization for infertility or for tubal cell sampling in the diagnosis of ovarian cancer, an endoscopically guided catheter that can be advanced through the fallopian tubes without incurring trauma or perforation is desirable. The fallopian tubes are delicate and tortuous, and previous intubation methods using guidewire and tapered catheter advancement can cause injury or perforation. Catheter advancement through the length of the fallopian tube is currently performed under fluoroscopic guidance, typically following contrast injection via hysterosalpingogram (HSG). If the HSG demonstrates tubal obstruction, passage of a guidewire and catheter can be performed to attempt to recanalize the obstruction. The incidence of tubal perforation during catheter recanalization of the fallopian tubes has previously been estimated at 4% of procedures.

[0004] Linear outward-everting balloons have also been used to deliver endoscopes called fallopian tubes. The balloon is first inverted inward within the lumen of the outer catheter, and the fallopian tube remains within the inverted balloon and inner catheter. The outer catheter is pressurized to a pressure of 10 atm, and advancement of the inner catheter inverts the balloon outward, and the fallopian tube advances forward in the fallopian tube. The fallopian tube moves forward twice as fast as the outward-everting balloon, which requires sequential retraction of the fallopian tube during balloon outward inversion to prevent the tip of the fallopian tube from perforating the fallopian tube. In one published study of the use of linear outward-everting balloon fallopianoscopy in 304 patients, tubal perforation was reported in 1.3% of patients.

[0005] Fallopian tube intubation has also been performed using a linear everting balloon catheter inserted through the working channel of a 5.5 French rigid hysteroscope. The hysteroscope is advanced into the uterus and manipulated to visualize the tubal ostia and guide the insertion of the linear everting balloon catheter into the fallopian tube. Introduction of the rigid hysteroscope into the uterus requires cervical manipulation with sharp tenacious forceps, causing severe pain to the patient. This painful procedure is generally difficult or impossible to perform as an in-clinic procedure. It would be desirable to develop techniques and devices that would allow fallopian tube intubation to be performed annually in a physician's office without the need for anesthesia to control pain during the procedure. Annual cell sampling from the fallopian tubes is desirable for screening to detect the development of ovarian cancer, which has been documented to originate from the fallopian tubes. Ovarian cancer develops at a tenfold higher incidence in patients carrying BRCA gene mutations. In the United States, there are 313,000 women aged 15 to 80 who carry BRCA gene mutations and require annual screening for the development of ovarian cancer. Additionally, 250,000 women are diagnosed with ovarian cysts annually, and currently, no non-surgical modality exists to determine whether an ovarian mass is a benign cyst or a malignant tumor. A non-traumatic, in-office device for fallopian tube cell sampling, akin to the traditional Papanicolaou test for cervical cancer, i.e., cervical cytology, is desirable. In cervical cytology, a speculum is inserted to allow the introduction of a cotton swab onto the surface of the cervix for cytological cell collection. The use of a tenaculum is not required, and the procedure can be performed as part of a standard annual in-office examination.

[0006] As described in commonly owned U.S. Patent Application No. 16 / 882,971, filed May 26, 2020, a substantially rigid 5 mm diameter cannula with a slight bend in its distal section previously contained an internal lumen containing a flexible balloon-tipped catheter and a CMOS-tipped endoscope lodged within a transparent tapered balloon. The endoscopic balloon catheter was advanced through the fallopian tube in a counter-rotational fashion, powered by a ratchet mechanism and a rotation mechanism contained within the device's handle. Additionally, a force-limiting mechanism was incorporated into the ratchet advancement function to prevent excessive tip advancement force that could lead to tubal perforation. Due to the mechanically driven nature of the balloon-tipped endoscopic catheter's advancement, this design limited tactile feedback of the catheter tip force exerted on the fallopian tube tissue. The discrete amount of applied tip force was preset by the force-limiting mechanism.

[0007] It is clinically desirable to provide the operating physician with highly instantaneous tactile feedback of endoscopic catheter tip force. Variable amounts of force may be required to traverse different segments of the fallopian tube, and the physician must be able to adjust the catheter advancement speed, rotation angle, rotation rate, and applied force depending on the individual tubal morphology. Therefore, a manually oscillating advancement endoscopic catheter is envisioned that will enable the physician to perform visually guided intubation of the entire length of the fallopian tube. Summary of the Invention [Means for solving the problem]

[0008] (Summary of the Invention) The present invention includes a substantially rigid cannula, which has some angulation at its distal portion and is typically configured to be inserted into a patient's uterus and rotated to align the angled tip with the ostium of a fallopian tube. A transparent, tapered-tipped catheter having a viewing element, such as a CMOS-tipped endoscope, is configured to be advanced distally through the inner lumen of the cannula with the viewing element on the shoulder of the transparent, tapered tip. A cell or tissue sampling element, such as a gauze cuff, may be positioned immediately proximal to the transparent, tapered tip and coaxially disposed over the outer surface of the catheter.

[0009] In an exemplary embodiment of the present invention, a gauze cuff may be used to collect cells from the inner surface of the fallopian tube. The shoulder of the gauze cuff is initially positioned so that it fits flush with the distal end of the cannula when the cannula is advanced under endoscopic guidance through the patient's cervical os into the uterus. The majority of the length of the transparent tapered tip is positioned distal to the distal end of the CMOS-tipped endoscope to provide, for example, a 5-7 mm long field of view in front of the endoscope. Rotation of the cannula is performed to align the tapered-tipped endoscope with either the left or right ostium of the fallopian tube. The tapered-tipped catheter of the endoscope can be advanced into the fallopian tube while the distal end of the cannula remains outside the ostium of the fallopian tube. Tapered-tipped catheters are typically configured to oscillate (with reciprocal rotation capability), rotating alternately clockwise and counterclockwise through an arc of 20° to 120°, typically 60°, in either direction from an initial vertical position, while the cannula and CMOS-tip endoscope inside the catheter remain stationary. Reciprocal rotation occurs as the tapered-tipped catheter is advanced forward through the length of the fallopian tube lumen. Reciprocal rotation allows the tapered-tipped catheter to be advanced through delicate fallopian tube structures that may be characteristically tortuous, collapsed, stenotic, or occluded. The transparent tapered tip uses its reciprocal rotational movement to gently dissect through collapsed or occluded fallopian tube segments, avoiding perforation, which is often experienced with the advancement of guidewires and 3Fr catheters in similar settings. Reciprocal rotation of the catheter is used instead of unidirectional rotation to avoid tubal twisting and rotation in the event of friction and adhesion of the tapered-tipped catheter to the inner surface of the fallopian tube. Due to the delicate nature of the fallopian tubes, traction and torsion can result in perforation or transection of the tube.

[0010] The cannula may be constructed from a polymeric material such as polyurethane, nylon, or polyethylene, or from stainless steel with a polymeric outer coating to provide atraumatic passage through the cervix into the uterus. The cannula's outer diameter is typically 3-5 mm, usually about 4 mm, with a working length of 20-30 cm, usually about 25 cm, and the distal 1 cm of its tip may incorporate a bending angle of about 20°. The transparent tapered conical tip may have a maximum outer diameter of about 1-1.3 mm, a rounded distal tip with a radius of 0.2-0.3 mm, and a length of about 7-10 mm.

[0011] The transparent tapered tip may be rigid, semi-rigid, flexible, or elastic, or a combination thereof. In some cases, the transparent tapered tip has a rigid or semi-rigid structure and is typically constructed from a transparent, non-elastic polymer such as polycarbonate, polyethylene terephthalate (PET), polyvinyl chloride, polyurethane, nylon, or similar materials. Such rigid or semi-rigid structures are sealed and filled with a transparent gas or liquid to allow visualization. Alternatively, the tip may be formed from an elastic material such as silicone rubber, polyisoprene, or polyurethane, which may be inflatable with a transparent gas or liquid to form an expanded balloon.

[0012] The catheter body may be constructed from flexible polymers such as polyurethane, polyvinyl chloride, PET, nylon, or similar materials to provide reinforcement against bending or kinking, or may be formed from a composite structure. The catheter shaft may incorporate a metallic helical reinforcement or a polymeric or metallic fiber braid to transmit torque along its length and allow for rotational oscillation (reciprocal rotation) as it advances through the tortuous fallopian tube. The working length of the catheter is approximately 35-40 cm, allowing the transparent tapered tip to navigate the typical 10 cm length of the fallopian tube distal to the end of the cannula. The proximal portion of the catheter, referred to elsewhere in this specification as the extension, may have a length of approximately 15-30 cm and may be joined to an outer section of stainless steel tubing that provides rigidity to the entire proximal section. As described in detail elsewhere herein, providing a rigid proximal extension and limiting the adjustable length of the tapered tip catheter to approximately 10 cm provides the catheter structure with sufficient column strength and torque control to advance and rotationally oscillate the catheter through the fallopian tube lumen. As described in detail elsewhere herein, the rigid proximal section also provides a structure for transmitting forces to the catheter for both axial advancement and rotationally oscillate.

[0013] In one exemplary embodiment, a circumferential fiber gauze cuff, typically having a length ranging from 0.5 to 1.5 cm, is attached to the distal end of the visualization catheter, typically located just proximal to the transparent tapered tip. The gauze cuff serves as a mechanism for cell collection as the endoscopic catheter advances down the length of the fallopian tube. The gaps in the gauze cuff retain endothelial fallopian tube cells. Cell collection is assisted by the reciprocal rotation of the cuff during catheter advancement and withdrawal. The gauze cuff may be constructed from materials such as silk, cotton, or polyester with a thickness of approximately 0.5 mm. Following advancement of the catheter down the length of the fallopian tube, the fallopianoscope device is removed from the patient, and the distal tip of the catheter, including the gauze cuff, is detached or cut off and submitted for cellular analysis.

[0014] In one exemplary embodiment, a handle on the proximal end of the cannula incorporates a mechanism for axially advancing and simultaneously rotationally oscillating the transparent tapered-tip catheter while maintaining a stationary CMOS tip endoscope. The handle may include a trigger that is squeezed to activate a ratchet mechanism that advances the elongated serrated plate in a forward direction. A locking mechanism is provided to prevent the elongated serrated plate from moving in the reverse direction. This locking mechanism may consist of spring-loaded serrations engaging the elongated serrated plate, with the angled serrations positioned to allow the plate to advance only in a forward motion. The locking portion may include an actuator to allow it to disengage from the elongated serrated plate and to allow insertion or retraction of the serrated plate. Bidirectional rotation of the catheter is achieved during its advancement. The catheter is attached to a rigid tube that is activated by an actuation mechanism in the handle. The surface of the rigid tube may include axially oriented splines or a frictional outer surface, e.g., a textured or outer-coated elastomer such as silicone rubber. The rigid tube may be attached to the elongated serrated plate in a manner that allows the tube to rotate radially relative to the plate. For example, open end caps on the elongated serrated plate may constrain the proximal and distal ends of the rigid tube while allowing it to rotate. A stepper motor attached to the handle may rotate a wheel or gear in contact with the splined rigid tube. The surface of the wheel in contact with the rigid tube may include a textured surface or an elastomeric coating to increase contact friction. When the handle trigger is depressed, the splined tube attached to the serrated plate is advanced in a forward direction, while the splined tube rotates bidirectionally when driven by the stepper motor. Alternative means of achieving tube rotation may be used.For example, reciprocal rotation may be achieved by using two electromagnets coupled to the catheter shaft, which are alternately activated to cyclically angle the catheter in a left-right direction toward a ferromagnetic strip resting on the inside of each handle half. A third mechanism for achieving bidirectional catheter rotation is the use of a rigid tube containing a sinusoidally shaped slot on its bottom surface, rotatably mounted to a sawtooth plate containing a straight slot in its center, and a pin fixed to the handle that protrudes through the slot in the sawtooth plate and the sinusoidal slot in the rigid tube. Advancement of the sawtooth plate with its attached rigid tube against the fixed pin causes the rigid tube to oscillate in a cyclical clockwise and counterclockwise rotational manner as the sinusoidal groove rides along the rigid pin.

[0015] A force limiter is provided to limit the force exerted at the distal tip of the catheter. During advancement of the balloon catheter through the fallopian tube, if the transparent tapered tip exceeds a preset amount of contact force against the inner wall of the tube, the force limiter prevents further catheter advancement. This prevents potential perforation of the fallopian tube. Force limiting of the catheter advancement may be implemented via magnetic coupling of the ratchet drive mechanism. The handle trigger may include a magnet coupled to a second magnet or a ferromagnetic disk attached to a sawtooth drive unit that contacts the elongated sawtooth plate. As the trigger is depressed to drive the catheter forward, excessive force exerted by the transparent tapered tip against the fallopian tube tissue causes the magnetic interface to decouple and release. The strength of the magnetic coupling may be adjusted to provide the desired degree of force limiting. Catheter force limiting may alternatively be provided by adding a compression spring to the trigger drive mechanism within the fallopian tube device handle. At the upper limit of desired catheter tip force, the trigger compresses the spring rather than driving the serrated plate forward.

[0016] The handle houses electronic components used to process video signals generated by an electronic imaging element, such as a CMOS chip, located within or adjacent to the conical catheter tip. The imaging element is provided as part of a separate "microendoscope" incorporating the CMOS or other electronic imaging element. Power is supplied to the CMOS chip or electronic imaging element by a conductive cable that extends the length of the catheter proximally to a control circuit board within the fallopianoscope device handle. Video signals acquired by the imaging element are transmitted through a second cable coaxially positioned relative to the power cable along the length of the catheter. The coaxial power and signal transmission cable may be tightly bound by an outer sheath of a polymeric material, such as polyethylene terephthalate (PET) heat shrink tubing, or an outer sheath of PET heat shrink material attached to a helically wound coil of flat stainless steel or other metal foil. The helically wound coil and outer sheath attached to the coaxial conductive cable have a combined outer diameter smaller than the inner diameter of the catheter, allowing the CMOS chip to remain stationary when the transparent tapered tip and catheter are rotated relative to each other. Additionally, torsional stability is provided to the coaxial conductive cable by a helically wound coil and outer sheath to prevent rotation of the CMOS chip, providing a stable video image. In other cases, instead of a CMOS video chip, the imaging element may be an optical fiber, with a distal lens that transmits an optical image to imaging circuitry in the handle and is oriented for viewing within the transparent tapered tip.

[0017] A video monitor is integrated into the handle and may be axially pivoted to allow the physician to simultaneously view the video image and the patient's anatomy.

[0018] The application of a vibrating endoscopic catheter to fallopian tube intubation has been described in detail. The principle of bidirectional reciprocal rotation of a transparent tapered-tip endoscopic catheter with limited advancement force may also be applied to other anatomical structures involving delicate tubular or vascular structures within the body. For example, rather than an angled 4 mm diameter cannula, a vibrating endoscopic catheter may be advanced through the working channel of a cystoscope, and a vibrating transparent tapered-tip catheter may be advanced in a retrograde fashion through the length of the ureter to remove an obstructed kidney stone or dilate a ureteral stricture. Another version of the device may be advanced through the working channel of a duodenoscope and used to dilate an intraductal stricture or to intubate the pancreatic or cystic duct to remove an obstructed gallstone. Other versions of the vibrating transparent tapered-tip endoscopic catheter may be applied to blood vessels, such as arteries or veins, to recanalize occlusions caused by thrombus or atherosclerotic disease. Occlusions within arteriovenous grafts used for vascular access in renal dialysis may be similarly addressed. Recanalization of occluded tubular device implants can also be performed using a vibrating endoscopic catheter. Ventriculoperitoneal shunts are placed in the treatment of hydrocephalus, and these shunts often occlude over time. A vibrating, transparent, tapered-tip endoscopic catheter can be inserted under a shunt laparoscope to cannulate the length of the ventriculoperitoneal shunt and remove any obstructions within the shunt.

[0019] The vibrating endoscopic catheter may also serve as an access device for delivering intraluminal stents or intraluminal implants. The gauze cuff of the described device may be replaced with a self-expanding vascular stent deployed following recanalization of an arterial or venous occlusion using the transparent tapered-tip catheter of a fallopianoscope or other endoscopic catheter assembly of the present invention. The vibrating endoscopic catheter may be used to perform sinusoscopy, i.e., to cross strictures within the nasal sinuses and deliver bioabsorbable stents to correct obstructing strictures. Ureteral stents may also be placed via the device.

[0020] In a first aspect, the present invention provides a fallopianoscope intended for use with a hysteroscope or other hysteroscopic access device. The fallopianoscope includes a cannula having an angled tip oriented to engage the tubal ostium when the cannula is introduced transcervically, typically through the hysteroscope, into a patient's uterus. A catheter has a distal viewing tip configured to be advanced from the distal end of the cannula through the cervical ostium into the patient's uterus. A viewing chamber has a widened proximal end attached to the distal viewing tip of the catheter, and the viewing chamber is at least partially transparent and typically tapered distally to provide a clear viewing area for the endoscope and atraumatic advancement into the fallopian tube.

[0021] In certain embodiments, the viewing chamber may be completely transparent, may comprise a pre-formed inflatable or other shell, and / or may comprise a pre-formed conical shell with a narrow tip that, when separated by a conical surface, is configured to allow atraumatic advancement through the lumen of the fallopian tube while also providing a clear view of the lumen wall. In specific cases, the catheter may have a diameter ranging from 0.75 mm to 1 mm, the base of the pre-formed shell having a diameter ranging from 1 mm to 1.25 mm, and the pre-formed shell having a length ranging from 4 mm to 7.5 mm.

[0022] In addition to providing visualization of the interior of the fallopian tube lumen, the fallopianoscope of the present invention may further comprise a device for cell collection, tissue sampling, biopsy, or other diagnostic procedures. For example, a fabric (gauze) cuff, brush, or other cell collection element is located on the exterior of the catheter, typically just proximal to the viewing chamber.

[0023] The fallopianoscope of the present invention typically includes a handle attached to the proximal end of the cannula, the handle configured to advance the catheter distally from the distal end of the cannula. The handle includes a drive assembly, which is typically configured to simultaneously advance and rotationally oscillate the catheter. For example, the drive assembly may include a trigger coupled to a ratchet mechanism that incrementally advances the catheter. The drive assembly typically further includes a mechanism for rotationally oscillating the catheter. In one example, the mechanism includes a motor-driven rocker arm that engages with and rotationally oscillates the catheter or the catheter extension. Alternatively, the mechanism includes a pin fixed within the handle that, when advanced by the trigger and ratchet, tracks in a sinusoidal, zigzag, or other serpentine groove formed in the outer surface of the catheter or the catheter extension, causing the catheter to rotationally oscillate. As a further alternative, the catheter can be rotationally oscillated by coupling a laterally adjacent pair of electromagnets to the catheter or its extension. By providing ferromagnetic strips on opposite sides of the handle, and alternatively by energizing two magnets, the catheter can alternatively be rotated in opposite rotational directions.

[0024] In a second aspect, the present invention provides a method for accessing a patient's fallopian tubes. The method includes transcervically introducing a distal end of a cannula into the patient's uterus and engaging the patient's tubal ostium. A catheter having a distal viewing tip is advanced from the distal end of the cannula through the patient's tubal ostium and into the patient's fallopian tube. The catheter is then atraumatically advanced through the patient's fallopian tube while viewing the interior of the tube through a tapered viewing chamber attached to the distal viewing tip of the catheter.

[0025] In a particular example of the method of the present invention, the viewing chamber has a wide proximal end attached to the distal viewing tip of the catheter, and the viewing chamber is at least partially transparent and tapered distally to provide both a clear viewing area for the endoscope and atraumatic advancement into the fallopian tube. The viewing chamber is typically fully transparent and may include a preformed shell that may be conical in shape. In a specific example, the catheter may have a diameter ranging from 0.75 mm to 1 mm, and the base of the preformed shell, when inflated, has a base diameter ranging from 1 mm to 1.25 mm and a length ranging from 4 mm to 7.5 mm.

[0026] The methods often further include diagnostic tests such as cell collection, tissue collection biopsy, and the like. In particular, the catheter may be used to collect and withdraw cells from the fallopian tube, for example, by engaging a cell collection surface on the outer surface of the catheter against the inner wall of the fallopian tube. In specific cases, engaging the cell collection surface typically involves rotationally oscillating the catheter while gradually advancing it using a translating ratchet mechanism. The present invention provides, for example, the following. (Item 1) A fallopian tube scope, comprising: a cannula having an angled tip oriented to engage the tubal ostium when the cannula is introduced transcervically into the patient's uterus; a catheter having a distal viewing tip configured to be advanced from the distal end of the cannula through the cervical os and into the patient's uterus; a viewing chamber having a widened proximal end attached to the distal viewing tip of the catheter; wherein the viewing chamber is at least partially transparent and tapered distally to provide both a clear viewing area for an endoscope and atraumatic advancement into the fallopian tube. (Item 2) Item 10. The fallopian tube scope of item 1, wherein the viewing chamber is completely transparent. (Item 3) Item 10. The fallopian tube of item 1, wherein the viewing chamber comprises a pre-formed inflatable shell. (Item 4) 4. The fallopian tube according to item 3, wherein the preformed shell is conical in shape. (Item 5) Item 5. The fallopian tube according to item 4, wherein the catheter has a diameter in the range of 0.75 mm to 1 mm, and the base of the preformed shell, when inflated, has a base diameter in the range of 1 mm to 1.25 mm and a length in the range of 4 mm to 7.5 mm. (Item 6) 2. The fallopian tube of claim 1, further comprising a cell collection element located on the exterior of the catheter proximal to the viewing chamber. (Item 7) Item 1. The fallopianoscope of item 1, further comprising a handle attached to the proximal end of the cannula and configured to advance the catheter distally from the distal end of the cannula. (Item 8) 8. The fallopianoscope of item 7, wherein the handle comprises a drive assembly configured to simultaneously advance and rotationally oscillate the catheter. (Item 9) 9. The fallopianoscope of claim 8, wherein the drive assembly includes a trigger coupled to a ratchet mechanism configured to incrementally advance the catheter. (Item 10) 10. The fallopian tube according to item 9, wherein the drive assembly further comprises a motor-driven rocker arm that engages with and rotationally oscillates the catheter or an extension of the catheter. (Item 11) 10. The fallopianoscope of item 9, wherein the drive assembly further comprises a pin fixed within the handle, the pin tracking in a serpentine groove formed within the outer surface of the catheter or the extension of the catheter when the catheter is advanced by the trigger and ratchet, causing the catheter to oscillate rotationally. (Item 12) 1. A method for accessing a patient's fallopian tubes, the method comprising: introducing a distal end of a cannula transcervically into the patient's uterus and engaging a tubal ostium of the patient; advancing a catheter having a distal viewing tip from the distal end of the cannula through the patient's tubal ostium and into the patient's fallopian tube; atraumatically advancing the catheter through the patient's fallopian tube while viewing the interior of the fallopian tube through a tapered viewing chamber attached to the distal viewing tip of the catheter; A method comprising: (Item 13) 13. The method of claim 12, wherein atraumatically advancing a catheter through the patient's fallopian tube while visualizing the interior of the fallopian tube comprises rotationally oscillating the catheter. (Item 14) Item 13. The method of item 12, wherein the viewing chamber has a widened proximal end attached to the distal viewing tip of the catheter, the viewing chamber being at least partially transparent and tapering distally to provide both a clear viewing area for an endoscope and atraumatic advancement into the fallopian tube. (Item 15) Item 13. The method of item 12, wherein the viewing chamber is completely transparent. (Item 16) Item 15. The method of claim 14, wherein the viewing chamber comprises a pre-formed shell. (Item 17) Item 17. The method of item 16, wherein the preformed shell is conical in shape. (Item 18) Item 18. The method of item 17, wherein the catheter has a diameter in the range of 0.75 mm to 1 mm, the base of the preformed shell has a diameter in the range of 1 mm to 1.25 mm, and the preformed shell has a length in the range of 4 mm to 7.5 mm. (Item 19) 18. The method of claim 17, further comprising collecting cells from the fallopian tube. (Item 20) 20. The method of claim 19, wherein collecting cells from the fallopian tube further comprises engaging a cell collection surface on an outer surface of the catheter against an inner wall of the fallopian tube. (Item 21) 21. The method of claim 20, wherein engaging the cell collection surface comprises rotationally oscillating the catheter. (Item 22) 22. The method of claim 21, wherein atraumatically advancing the catheter comprises gradually translating the catheter using a ratchet mechanism. (Item 23) 22. The method of claim 21, wherein atraumatically advancing the catheter comprises manually grasping the proximal end of the catheter. (Item 24) 24. The method of claim 23, wherein atraumatically advancing the catheter further comprises manually translating and / or rotating the catheter while sensing tactile feedback. (Item 25) A fallopian tube scope, comprising: a cannula having an angled tip oriented to engage the tubal ostium when the cannula is introduced transcervically into the patient's uterus; a catheter having a distal viewing tip configured to be advanced from the distal end of the cannula through the cervical os and into the patient's uterus; a viewing chamber having a widened proximal end attached to the distal viewing tip of the catheter; wherein the catheter is translatably and rotationally received within a lumen of the cannula, and a proximal end of the catheter is configured to be manually grasped by a user, enabling manual translation and rotation with tactile feedback. (Item 26) 26. The fallopian tube scope of item 25, wherein the viewing chamber is at least partially transparent and tapered distally to provide both a clear viewing area for the endoscope and atraumatic advancement into the fallopian tube. [Brief explanation of the drawings]

[0027] [Figure 1] 1A-1B show elements of a prior art linear outward everting balloon catheter used to perform a salpingoscopy.

[0028] [Figure 2] FIG. 2 illustrates the prior art balloon eversion of FIG. 1 with an endoscope extending beyond the eversion balloon.

[0029] [Figure 3] FIG. 3 shows the pointed tip of a tenacious forceps used to manipulate the cervix during insertion of a conventional rigid hysteroscope.

[0030] [Figure 4] 4A-4B show the configuration of a vibrating endoscopic catheter of the present invention for fallopian tube intubation, referred to herein as a fallopian tube scope.

[0031] [Figure 5] 5A-5B illustrate the inability of a prior art endoscope deployed with a linear outward everting balloon catheter to visualize the lumen of a non-dilated fallopian tube.

[0032] [Figure 6]6A-6B illustrate the advancement of the transparent tapered tip of the fallopian tube scope of the present invention, showing the dilation of the fallopian tube during its advancement to facilitate visualization of the fallopian tube lumen.

[0033] [Figure 7] FIG. 7 illustrates an embodiment of the fallopianoscope of the present invention employing a trigger handle for distally advancing the transparent tapered tip of the fallopianoscope of the present invention.

[0034] [Figure 8] FIG. 8 is an exploded view depicting components of a fallopianoscope, including a reusable handle, a disposable cannula, and a disposable catheter.

[0035] [Figure 9] FIG. 9 shows a catheter advancement mechanism incorporating a force-limiting feature located within the handle.

[0036] [Figure 10] 10A-10B show a handle mechanism incorporating a releasable lock that prevents retrograde catheter migration.

[0037] [Figure 11] 11A-11C show a mechanism for rotationally oscillating (reciprocally oscillating) a fallopianoscope of the present invention, which has an alternative forward force limiting mechanism.

[0038] [Figure 12] 12A-12B show an alternative mechanism for rotationally oscillating (reciprocally oscillating) the fallopianoscope of the present invention.

[0039] [Figure 13A] 13A to 13D show a third mechanism for rotationally oscillating (reciprocally oscillating) the fallopianoscope of the present invention. [Figure 13B] 13A to 13D show a third mechanism for rotationally oscillating (reciprocally oscillating) the fallopianoscope of the present invention. [Figure 13C]13A to 13D show a third mechanism for rotationally oscillating (reciprocally oscillating) the fallopianoscope of the present invention. [Figure 13D] 13A to 13D show a third mechanism for rotationally oscillating (reciprocally oscillating) the fallopianoscope of the present invention.

[0040] [Figure 14] 14A-14D depict a further alternative mechanism for rotationally oscillating (reciprocally oscillating) the fallopianoscope of the present invention using electromagnetic wave actuation.

[0041] [Figure 15] FIG. 15 shows the arrangement of elements within the handle of a manually vibrating endoscopic catheter for tubal intubation.

[0042] [Figure 16] FIG. 16 depicts an exploded view of the internal elements of the handle of a manually vibrating endoscopic catheter for tubal intubation.

[0043] [Figure 17] FIG. 17 shows an alternative positioning of the video monitor attached to a wristband on the operating physician.

[0044] [Figure 18] FIG. 18 depicts the components and configuration of a manually vibrating endoscopic catheter incorporating a video monitor wrist attachment in place of the device handle. DETAILED DESCRIPTION OF THE INVENTION

[0045] (Detailed Description of the Invention) FIG. 1A shows a previous catheter 10 used for fallopian tube surgery. The catheter 10 uses an outward-everting balloon 13 from its distal end through the fallopian tube to deliver an endoscope into the fallopian tube. The catheter 10 is pressurized with saline, and manual advancement of the proximal connector 11 toward the distal connector 12 outwardly everts the balloon from the distal tip of the catheter 10. FIG. 1B is a cross-sectional view of the distal portion of the catheter 10, illustrating the distal, everted end of the inward-everting balloon 13 attached to the inner wall of the distal end of the catheter 10 and the proximal end of the inward-everting balloon 13 attached to the distal end of the inner catheter 14. An endoscope 15 is placed inside the inner catheter 14 and the inward-everting balloon 13.

[0046] FIG. 2 depicts a linear outward-everting balloon catheter 10 everting the balloon 13 outward through the fallopian tube 16. During the outward-everting process, the balloon 13 assumes a double-walled toroidal configuration, which compresses the endoscope 15 and drives it forward at twice the speed of the advancing balloon 13. The exposed endoscope 15 may be driven into the wall of the fallopian tube 16, causing dissection or perforation. Therefore, salpingoscopy with the linear outward-everting balloon catheter 10 is performed gradually, and the outward inversion is stopped after a short distance to decompress the catheter 10 and allow the endoscope 13 to be pulled back into the outward-everting balloon 13 and inner catheter 14.

[0047] FIG. 3 shows the instrumentation required to perform hysteroscopy using a rigid hysteroscope 17. Tubal catheterization is also performed by inserting a guidewire and catheter through the working channel of the hysteroscope 17 into the fallopian tubes. To insert the rigid 5 mm or 7 mm diameter hysteroscope 17 into the uterus 19, the sharp distal tip of a tenacious forceps 19 is used to grasp and manipulate the cervix 20 during introduction of the hysteroscope 17 into the uterus 19. Application of the tenacious forceps 19 is extremely painful and generally requires anesthesia, including sedation in the paracervical region and injection of a local anesthetic such as lidocaine. A colposcope 21 is also generally used to retract vaginal tissue 22 during hysteroscopy. Application of the colposcope 21 is tolerated to a greater extent by patients, and its use is a component of annual pelvic examinations performed in conjunction with cervical cytology, which is performed to diagnose cervical malignancies.

[0048] FIG. 4A depicts a fallopianoscope device 23 of the present invention configured to be advanced down the length of a fallopian tube in a physician's office setting without causing patient discomfort or trauma or injury to the patient's fallopian tube. The fallopianoscope device 23 includes a cannula 24, typically a rigid cannula, having an outer diameter of approximately 4 mm with an angled distal end. The cannula 24 is attached to an extension 24a extending distally from a device handle 26. The device handle 26 includes a video display 34 on its proximal side to allow the physician to view the endoscopic image. The interior of the device handle 26 contains a motorized drive system that rotates a splined tube 28a attached to a catheter 28, which is placed inside the lumen of the rigid cannula 24, relative to one another. A transparent tapered tip 29 is attached to the distal end of the catheter 28. The transparent tapered tip 29 and catheter 28 can be activated by a motor drive in the handle 26 to rotate reciprocally clockwise and counterclockwise with a sweep angle of up to 180° at a frequency of approximately 2-5 cycles per second. Infusion ports 32 and 33 can be connected to allow fluid infusion through the device 23. The infusion port 32 can incorporate a check valve, which allows inflation of the transparent tapered tip 29 through the catheter 28 if the transparent tapered tip 29 is an inflatable elastic or inelastic balloon. The infusion port 33 can allow fluid infusion through the rigid cannula 24 for uterine dilation, allowing for improved visualization of the tubal ostia for intubation with the transparent tapered tip 29. Figure 4B is an enlarged view of the distal tip of the fallopian tube device 23, showing the transparent tapered tip 29 attached to the distal end of the catheter 28. Catheter 28 has an outer diameter of about 0.8 mm, and transparent tapered tip 29 has a maximum outer diameter of about 1.1 mm and a length of about 5-10 mm.The distal tip 30 of the CMOS-tipped endoscope extends into the proximal portion of the transparent tapered tip 29, allowing visualization of the cervix, uterus, and fallopian tubes as the fallopianoscope device 23 is advanced into position at the tubal ostium and visualization of the fallopian tubes as the catheter 28 is advanced along its length. The tapered configuration of the transparent tip 29 serves to retract the wall of the undilated fallopian tube as the catheter 28 is advanced forward out of the cannula 24. The distal end of the cannula 24 remains outside the tubal ostium. A gauze or other fibrous cuff 31 is attached to the distal end of the catheter 28 just proximal to the transparent tapered tip 29. The gaps in the gauze or other fibrous cuff 31 allow the catheter 28 to sample and retain endothelial cells from the fallopian tube during insertion and removal.

[0049] 5A illustrates that the tip of the endoscope 15 resting against the collapsed tissue of the fallopian tube 16 prevents visualization of the fallopian tube lumen as the endoscope 15 advances from a prior art linear outward everting balloon 13. FIG. 5B shows the resulting endoscope image 35 with the lumen 36 only barely perceptibly collapsed. With such limited imaging, continued endoscope advancement during balloon outward eversion risks perforating the fallopian tube.

[0050] FIG. 6A illustrates the advancement of a transparent tapered tip 29 on the distal end of a catheter 28 within a collapsed fallopian tube 16. The transparent tapered tip 29 dilates the fallopian tube 16, and because the transparent tapered tip 29 extends a distance "X" distally relative to the tip 30 of the CMOS-chip endoscope, this provides a visual length of approximately 7 mm of the fallopian tube lumen. FIG. 6B shows a corresponding endoscopic image 35, in which the patent lumen 36 is clearly visible. The transparent tapered tip 29 can now be advanced into the fallopian tube lumen 16 with reduced risk of perforating the wall of the fallopian tube 16.

[0051] FIG. 7 shows a configuration of a fallopianoscope device employing a trigger 37 in the handle 26 to advance the catheter 28. Depressing the trigger 37 drives a serrated plate 38 forward. A rigid tube 40 is connected to the serrated plate 38 in a manner that allows it to rotate relative to the serrated plate 38 while being constrained against axial movement therebetween. A small-diameter rigid tube 41 extends forward from the rigid tube 39 and slides within the inner lumen of the angled cannula 24. The catheter 28 is joined to the inner lumens of the rigid tube 40 and the small-diameter rigid tube 41. Rotation of the rigid tube 40 causes rotation of the catheter 28. A transparent tapered tip 29 is attached to the distal end of the catheter 28. A microendoscope, typically a CMOS-tipped endoscope, extends through the lumen of the catheter 28, its distal tip 30 resting within the transparent tapered tip 29. Video images acquired by the microendoscope are viewed on a video display 34. A gauze cuff 31 is attached to the distal end of catheter 28 just proximal to transparent tapered tip 29. Gauze cuff 31 is used to collect endothelial cells from the fallopian tube as catheter 28 is advanced and withdrawn the length of the tube.

[0052] 8 is an exploded view of the fallopianoscope of the present invention, depicting the reusable handle 26, including the internal drive mechanism and video display 34. The proximal end 24a of the disposable cannula 24 is removably attached to the reusable handle 26. The catheter 28 is included as part of a disposable assembly that includes a serrated plate 38, a rigid tube 40, a small-diameter rigid tube 41, a transparent tapered tip 29, a gauze cuff 31, and a microendoscope. Bearings 39 are fixed to the proximal and distal ends of the serrated plate 38 to rotationally support the rigid tube 40, allowing the subassembly of the rigid tube 40, the small-diameter rigid tube 41, the transparent tapered tip 29, the gauze cuff 31, and the microendoscope to rotate relative to the serrated plate 38 and handle 26 about their longitudinal axes. The subassembly is first inserted into the reusable handle 26, followed by placement of the disposable angled cannula 24 into the fixture with the reusable handle 26, coaxially covering the transparent tapered tip 29, catheter 28, and small diameter rigid tube 41.

[0053] FIG. 9 shows an embodiment of a drive mechanism incorporated within the fallopianoscope device handle 26. Trigger 37 pivots on pin 41, and tension spring 42 returns trigger 37 to its rest position following actuation. Linkage 43 has an elongated slot 44 at its lower end, which also pivots on pin 41. An upper or superior edge 43a of linkage 43 includes serrations that interlock with serrations 38a on the lower surface of serrated plate 38. A magnet 45 is attached to the upper portion of trigger 37 and interfaces with a ferromagnetic plate 46 attached to linkage 43. When trigger 37 is depressed (manually closed by the user), magnet 45 retracts serrated linkage 43 in a forward direction, driving serrated plate 38 forward as well. Magnetic coupling of trigger 37 to linkage 43 limits the forward driving force that can be applied to the catheter, reducing the risk of injury to the fallopian tube. That is, the forward driving force of serrated plate 38 is limited by the magnetic force between magnet 45 and ferromagnetic plate 46. The force limiting mechanism of the catheter tip against the fallopian tube is determined by the magnetic coupling force of the drive unit located in handle 26. The angle of the serrations on serrated plate 38 and linkage 43 is configured to cause forward-oriented advancement of serrated plate 38 when trigger 37 is depressed. When trigger 37 is released, tension spring 42 pulls trigger 37 forward, retracting linkage 43 to its original position. Elongated slot 44 allows linkage 43 to drop against pin 41, facilitating reverse movement of its upper serrations against serrated plate 38. Compression spring 47 provides resistance to serrated plate 38, preventing it from moving in the reverse direction during return movement of linkage 43.

[0054] Figure 10A shows the drive mechanism of the fallopianoscope device handle 26 incorporating a releasable lock 48 for the serrated plate 38, which limits it to one-way forward advancement. Figure 10B is a close-up view of the releasable lock 48, illustrating its components, including locking serrations 49 that are raised by a compression spring 50 to engage corresponding serrations on the serrated plate 38. An actuator knob 51 can be depressed to release the locking serrations 49 during insertion of the serrated plate 38 into the reusable handle 26 or during retraction of the serrated plate 38 for catheter tip retraction.

[0055] FIG. 11A illustrates one embodiment of a mechanism for achieving vibrational catheter rotation. A stepper motor (not shown) inside the reusable handle 26 has an attached gear face 54 positioned on the outside of the handle 26, which interfaces with the rigid tube 40. In this embodiment, the rigid tube 40 is splined, with axial gear sawtooth on its outer surface meshing with sawtooth on the gear face 54. FIG. 11B is a close-up view of the motor drive mechanism, showing the drive gear 54 meshing with the surface of the splined gear 53 on the rigid tube 40. The angle and frequency of catheter rotation can be adjusted via input of electronic control parameters to the stepper motor. FIG. 11C depicts an alternative mechanism for catheter tip force limiting. The upper portion of the trigger 37 includes a coupler 55 containing a cruciform pin 56 that is spring-loaded via a compression spring 57. The cruciform pin 56 rides along an arcuate groove 58 and engages with the sawtooth of the serrated plate 38 to produce forward motion when the trigger 37 is depressed. When the maximum set catheter tip contact force is exceeded, spring 57 compresses as the trigger is pulled, preventing forward advancement of the catheter.

[0056] 12A and 12B depict an alternative drive mechanism for rotation of the vibratory catheter. A motor 59 is mounted inside the body of the handle 26. The motor 59 rotates a disk carrying an offset pin 60 that rotates continuously in a groove in a pivotally mounted plate 61, causing a pendulum-like reciprocating motion. The bottom edge of the grooved plate 61 contacts the outer surface of the rigid tube 40 with sufficient friction to cause the rigid tube 40 to oscillate rotationally about its axis. The bottom edge of the grooved plate 61 may be partially or entirely covered with a layer of elastomeric material, such as silicone rubber or polyurethane, to promote frictional contact. The surface of the rigid tube may be smooth or may include multiple axial grooves or other surface features or finishes if additional friction is required for rotation.

[0057] Figures 13A-13D show additional mechanisms for rotationally oscillating the catheter as it is advanced. A stainless steel pin 62 is anchored within the body of the handle 26 (Figure 13A). The pin 62 protrudes through a slot in a serrated plate 38 on the bottom of the rigid tube 40. Figure 13B shows components of a disposable catheter 28 of a fallopianoscopic device, also shown in Figure 8B, including the serrated plate 38 and the rigid tube 40. Figure 13C is a bottom view of the serrated plate 38, showing the slot 63 extending through the entire thickness of the serrated plate 38. Figure 13D is an enlarged view of a portion of the rigid tube 40, showing the sinusoidal grooves 63 in the wall of the rigid tube 40 and the pin 62 protruding through the sinusoidal grooves 63. When trigger 37 is depressed to drive sawtooth plate 38 forward, sinusoidal grooves 64 in rigid tube 40 advance along stationary pin 62, rotating rigid tube 40 in a cyclical clockwise and counterclockwise manner.

[0058] FIG. 14A shows another embodiment of a fallopianoscope device with a trigger 37 that actuates the serrated linkage 43 to drive the serrated tubular rod 65 forward. A catheter 28 with a transparent tapered tip 29 that protects the distal tip 30 of the microendoscope is positioned within the lumen of the serrated tubular rod 65. As seen in FIG. 14B, flanges 68 attached to the catheter 28 protrude out of slots 67 at the top of the serrated tubular rod 65. Electromagnets 69 are attached to the left and right sides of the flanges 68, and ferromagnetic strips 70 are attached to the left and right halves of the handle 26 in juxtaposition with the electromagnets 69. When the serrated tubular rod 65 is driven forward by depressing the trigger 37, the left and right electromagnets 69 are alternately activated to cause the flanges 68 to rotationally oscillate the catheter 28. FIG. 14C is a side view of the serrated tubular rod 65 containing the catheter 28 within its lumen. 14D is a cross section of serrated tubular rod 65 at the location of slot 67, showing flange 65 attached to the top surface of catheter 28 and electromagnets 69 attached to the left and right surfaces of flange 68. Slot 67 is wide enough to allow deviation of the left and right sides of flange 65 to effect rotation of catheter 28 through an angle of approximately 120°.

[0059] Figure 15 is a diagram of the device with the handle 26 opened to reveal the configuration of the internal components. The cannula 24 is permanently attached to the slotted tube 25. The slotted tube 25 fits within a recess 36 inside the handle 26 so that it can rotate while being constrained against axial movement. The catheter 28, including the attached transparent tapered tip 29, is sufficiently flexible to navigate through the tortuous anatomy of the fallopian tube. A substantially rigid tube 137 is joined to the proximal portion of the transparent tapered tip catheter 28. The catheter 28 has an outer diameter of approximately 1 mm, while the rigid tube 137 has an outer diameter of approximately 3 mm. A polymer knob 140 attached to the proximal end of the rigid tube 137 is grasped by the physician and used to advance the catheter 28 out of the cannula 24 with an oscillatory, rotational motion.

[0060] Figure 16 is an exploded view of the interior contents of the handle 26. A transparent tapered tip 29 is attached to the distal end of a flexible catheter 28. A CMOS chip endoscope 130, consisting of a distal CMOS camera chip, a flexible electronic cable, and a fiber optic cable for light transmission, is bonded to the interior of the flexible catheter 28. A length of electronic and fiber optic cable 139 extends out from the proximal end of the catheter 28 for connection to a control circuit board and a light-emitting diode. The proximal section of the flexible catheter 28 is bonded to a substantially rigid tube 137. The electronic and fiber optic cable 139 exits through an opening 138 in the rigid tube 137. The rigid tube 137 is placed inside the slotted tube 25, and the electronic and fiber optic cable 139 exits through a slot 125 in the slotted tube 25. The slot 125 has a length greater than 10 cm to allow the rigid tube 137 to be advanced distally over its entire length of 10 cm, causing the flexible catheter 28 to traverse the length of the fallopian tube. The slot 125 includes a width that encompasses an angle of approximately 120°, allowing bidirectional rotation of the rigid tube of approximately 60° in either direction. The slotted tube 25 descends into a recess 136 in the device handle 26. A rotational actuator 27 is located on the exterior of the proximal face of the handle 26. The rotational actuator 27 may be a 3 mm diameter rod or pin attached to the proximal end of the slotted tube 25, which is manipulated to angle the tip of the cannula 24 along the left or right ostium of the fallopian tube.

[0061] 17 depicts an alternative embodiment of the device with a video monitor 133 attached to the physician's wrist via a wristband 141. The proximal portion of the cannula 24 is grasped by the operator, and the endoscopic catheter 28 is advanced through the fallopian tube with an oscillating motion. The cannula 24 exhibits a small profile compared to previous handles, which facilitates visualization of the patient's superficial anatomy during operation of the device.

[0062] Figure 18 shows the device configuration without the handle. A cannula 24 is attached to a slotted tube 25, and a catheter 28 including an attached transparent tapered tip 29 resides within the cannula 24. A substantially rigid tube 137 is joined to the proximal portion of the transparent tapered tip catheter 28. A knob 140 on the proximal end of the rigid tube 137 is grasped by the physician and used to advance the catheter 28 with an oscillatory motion. An electronic and fiber optic cable 139 is connected to an endoscope inside the catheter 28 and exits through an opening 138 in the rigid tube 137 and a slot 125 in the slotted tube 25. The electronic and fiber optic cable 39 is connected to a video monitor unit 133 that includes a wristband 141 that is worn on the wrist of the physician operating the device.

[0063] While the present invention has been described herein with respect to certain illustrated embodiments, those skilled in the art will recognize and understand that it is not so limited. Rather, numerous additions, deletions, and modifications may be made to the illustrated embodiments without departing from the scope of the invention as claimed, including their legal equivalents. In addition, features from one embodiment may be combined with features of another embodiment and still fall within the scope of the invention as contemplated by the inventors. Furthermore, embodiments of the present disclosure have utility with a variety of different tool types and configurations.

Claims

[Claim 1] The invention described in this specification.

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