Oscillating endoscopic catheter for fallopian tube navigation

Abstract

A falloposcope intended for use with a hysteroscope to access a patient's fallopian tube, image the patient's fallopian tube, and collect a sample from the patient's fallopian tube includes a cannula having an angled tip oriented to engage a fallopian tube ostium as the cannula is introduced through the cervix of the hysteroscope into the patient's uterus. A catheter has a distal viewing tip configured to be advanced through a cervical opening from a distal end of the cannula into the patient's uterus. A viewing chamber has a wide proximal end attached to the distal viewing tip of the catheter and is at least partially transparent and generally tapered in a distal direction to provide a clear viewing area for a scope and atraumatic advancement into the fallopian tube.

Description

[0001] Cross-references to related applications

[0002] This application is a partial continuation and claims the benefit of U.S. Application No. 16 / 882,971 (Agent File No. 58840-703.201), filed May 26, 2020; it also claims the benefit of U.S. Provisional Application No. 63 / 105,801 (Agent File No. 58840-703.101), filed October 26, 2020, and U.S. Provisional Application No. 63 / 115,776 (Agent File No. 58840-703.102), filed November 19, 2020, the contents of each of which are incorporated herein by reference in their entirety. Invention Field

[0003] This invention generally relates to apparatus and methods for endoscopic access and navigation of the fallopian tubes in the uterus. More specifically, the invention relates to a force-limited, oscillating, transparent-tip endoscopic device that can be advanced to navigate the length of the fallopian tube. Background Technology

[0004] There is a need for an endoscopically guided catheter that can navigate through the fallopian tubes without causing trauma or perforation, for fallopian tube recanalization in infertility or for fallopian tube cell sampling in the diagnosis of ovarian cancer. The fallopian tubes are fragile and tortuous, and traditional cannulation methods using guidewires and tapered catheters can lead to injury or perforation. Currently, catheter advancement through the fallopian tubes is performed under fluoroscopic guidance, usually after hysterosalpingography (HSG) with contrast agent injection. If HSG shows fallopian tube occlusion, guidewire and catheter access can be established to attempt recanalization. The incidence of fallopian tube perforation during tubal recanalization was previously estimated at 4%.

[0005] Linear eversion balloons have also been used to insert an endoscope, called a fallopian tube endoscope, into the fallopian tube. The balloon is initially inverted within the lumen of the external catheter, while the fallopian tube endoscope resides within the inverted balloon and internal catheter. Pressurization of the external catheter to 10 atm causes the balloon to evert and the fallopian tube endoscope to advance forward. The fallopian tube endoscope moves forward at twice the speed of the everted balloon, making incremental retraction of the fallopian tube endoscope during balloon eversion necessary to prevent perforation of the fallopian tube by the endoscope tip. In a published study of 304 patients using linear eversion balloon fallopian tube endoscopes, fallopian tube perforation was reported in 1.3% of patients.

[0006] Tubal cannulation is also performed using a linear eversion balloon catheter inserted into the working channel of a 5.5Fr rigid hysteroscope. The hysteroscope is advanced into the uterus and manipulated to visualize the openings of the fallopian tubes and guide the linear eversion balloon catheter into the cannula. Introducing a rigid hysteroscope into the uterus requires manipulating the cervix with sharp-tipped single-jaw forceps, causing significant pain for the patient. This painful procedure is often difficult or impossible to perform as an in-office procedure. There is a desire to develop a technology and equipment that would allow annual screening for fallopian tube patency in a physician's office without the need for anesthesia to control pain during the procedure. There is also a desire to annually collect cell samples from the fallopian tubes for screening to detect the development of ovarian cancer, which has been shown to originate in the fallopian tubes. The incidence of ovarian cancer is ten times higher in patients carrying BRCA gene mutations. In the United States, 313,000 women aged 15 to 80 years of age carry BRCA gene mutations and require annual screening for ovarian cancer development. Furthermore, 250,000 women are diagnosed with ovarian cysts each year, and currently there is no non-surgical method to determine whether an ovarian mass is benign or malignant. The goal is to develop a non-invasive, in-office fallopian tube cytology sampling device, similar to the traditional Papinicoloau or Pap smear used for cervical cancer. In a Pap smear, a colposcope is inserted to allow a swab to be introduced onto the surface of the cervix for cytological cell collection. The use of single-jaw forceps would be unnecessary, and the procedure would be performed as a standard annual in-office examination.

[0007] Previously, as described in co-owned U.S. Patent Application 16 / 882,971, filed May 26, 2020, a substantially rigid 5mm diameter cannula, slightly curved in its distal portion, has a lumen containing a flexible balloon-tip catheter and a CMOS chip endoscope residing within a transparent conical balloon. The endoscopic balloon catheter is advanced through the fallopian tube via a reciprocating rotation, powered by a ratchet mechanism and a rotation mechanism included in the device handle. Furthermore, a force-limiting mechanism is incorporated into the ratchet advancement function to prevent excessive tip-advance force that could lead to fallopian tube perforation. Due to the mechanically driven nature of the balloon-tip endoscopic catheter advancement, tactile feedback of the catheter tip force applied to the fallopian tube tissue is limited in this design. The force-limiting mechanism is pre-set with discrete applied tip force values.

[0008] Clinically, surgeons are expected to receive essentially instantaneous tactile feedback on the force applied to the tip of the endoscopic catheter. Different force values ​​may be required to traverse different sections of the fallopian tube, and surgeons must be able to adjust the advancement speed, rotation angle, rotation speed, and applied force based on the morphology of individual tubes. Therefore, a manually oscillating endoscopic catheter could be envisioned to allow surgeons visually guided cannulation along the entire length of the fallopian tube. Summary of the Invention

[0009] The invention includes a substantially rigid cannula, typically with a slight angle at its distal portion, configured for insertion into the patient's uterus and rotation to align the angled tip with the opening of the fallopian tube. A transparent, tapered-tip catheter with an observation element, such as a CMOS chip endoscope, is configured for distal advancement through the lumen of the cannula, with the observation element located at the shoulder of the transparent tapered tip. A cell or tissue sampling element may be located directly proximal to the transparent tapered tip, such as a gauze cuff coaxially arranged on the outer surface of the catheter.

[0010] In an exemplary embodiment of the invention, a gauze cuff can be used to collect cells from the inner surface of the fallopian tube. When the cannula is advanced into the uterus through the cervical opening under endoscopic guidance, the shoulder of the gauze cuff is initially flush with the distal end of the cannula. Most of the length of the transparent tapered tip lies distal to the CMOS chip endoscope, for example, to provide a 5-7 mm field of view in front of the endoscope. The cannula is rotated to align the tapered tip endoscope with the left or right opening of the fallopian tube. The endoscopic tapered tip cannula can be advanced into the fallopian tube while the distal end of the cannula remains outside the fallopian tube opening. The tapered tip cannula is typically configured to rotate oscillate (providing reciprocating rotation capability) from an initial vertical position in any direction, rotating alternately clockwise and counterclockwise within an arc of 20° to 120° (typically 60°), while the cannula and CMOS chip endoscope within the cannula remain stationary. During reciprocating rotation, the tapered tip cannula advances forward through the length of the fallopian tube lumen. The reciprocating rotation allows the tapered-tip catheter to be advanced through the delicate structures of the fallopian tube, characterized by typical tortuosity, collapse, and narrowing or blockage. The transparent tapered tip gently dissects collapsed or blocked sections of the fallopian tube through its reciprocating rotation, avoiding the perforation experienced when using guidewires and 3Fr catheters in similar conditions. The reciprocating rotation of the catheter, rather than unidirectional rotation, avoids twisting and entanglement of the tube due to friction and adhesion between the tapered tip and the inner surface of the fallopian tube. Due to the fragile nature of the fallopian tube, traction and torsion can lead to perforation or transection.

[0011] The cannula can be made of polymer materials such as polyurethane, nylon, or polyethylene, or it can be made of stainless steel with an outer polymer coating to provide a non-invasive passage through the cervix into the uterus. The outer diameter of the cannula is typically 3-5 mm, usually around 4 mm, and the working length is 20-30 cm, usually around 25 cm. The distal 1 cm of its tip may contain a bend angle of approximately 20°. A transparent, tapered conical tip may have a maximum outer diameter of approximately 1-1.3 mm, a rounded distal tip radius of 0.2-0.3 mm, and a length of approximately 7-10 mm.

[0012] The transparent conical tip can be rigid, semi-rigid, flexible, or elastic, or a combination thereof. In some cases, the transparent conical tip will have a rigid or semi-rigid structure, typically made of a transparent, non-elastic polymer such as polycarbonate, polyethylene terephthalate (PET), polyvinyl chloride, polyurethane, nylon, or similar materials. This rigid or semi-rigid structure can be sealed and filled with a transparent gas or liquid to allow observation. Alternatively, the tip can be formed of an elastic material such as silicone rubber, polyisoprene, or polyurethane, and it can be inflated with a transparent gas or liquid to form an expanded balloon.

[0013] The catheter body can be constructed from flexible polymers such as polyurethane, polyvinyl chloride, PET, nylon, or similar materials, or it can be formed from a composite structure to provide reinforcements against bending or kinking. The catheter shaft may include a metal helical reinforcement, or a polymer or metal fiber braid, to transmit torque along its length and allow rotational oscillation (reciprocating rotation) as it passes through the tortuous fallopian tube. The working length of the catheter is approximately 35–40 cm to allow the transparent tapered tip to extend along a typical 10 cm length of the fallopian tube to the insertion end. The proximal portion of the catheter, referred to elsewhere in this document as the extension, may have a length of approximately 15–30 cm and may be bonded to an outer segment of a stainless steel tube, thereby making the entire proximal portion rigid. Providing a rigid proximal extension and limiting the flexible length of the tapered tip catheter to approximately 10 cm provides a catheter structure with sufficient column strength and torque control for advancing and rotating the catheter through the fallopian tube lumen, as described in detail elsewhere in this document. The rigid proximal portion also provides structures for transmitting force to the catheter for axial advancement and rotational oscillation, as described in detail elsewhere in this document.

[0014] In an exemplary embodiment, a circumferential fabric gauze cuff, typically 0.5-1.5 cm in length, is attached to the distal end of the observation catheter, usually proximal to the transparent, conical tip. The gauze cuff serves as a cell collection mechanism as the endoscopic catheter advances the length of the fallopian tube. The gaps in the gauze cuff retain endothelial fallopian tube cells. Cell collection is aided by the reciprocating rotation of the cuff during catheter advancement and withdrawal. The gauze cuff can be made of materials such as silk, cotton, or polyester, and is approximately 0.5 mm thick. After the catheter has advanced the length of the fallopian tube, the fallopian tube endoscope is removed from the patient, and the distal tip of the catheter containing the gauze cuff is dissected or cut and submitted for cell analysis.

[0015] In an exemplary embodiment, a handle on the proximal end of the cannula includes a mechanism for axially advancing and simultaneously rotating an oscillating transparent tapered tip catheter while holding a CMOS chip endoscope stationary. The handle may include a trigger that is depressed to actuate a ratchet mechanism that advances an elongated toothed plate forward. A locking mechanism is provided to prevent rearward movement of the elongated toothed plate. This locking mechanism may consist of spring-loaded teeth engaging the elongated toothed plate at angles that allow only forward advancement of the plate. The lock may include an actuator to allow it to release from engagement with the elongated toothed plate, allowing insertion or retraction of the toothed plate. The catheter undergoes bidirectional reciprocating rotation during its advancement. The catheter is attached to a rigid tube actuated by the actuation mechanism in the handle. The surface of the rigid tube may include an axial spline or a frictional outer surface; for example, a texture or outer coating of an elastomer (such as silicone rubber). The rigid tube may be attached to the elongated toothed plate in a manner that allows radial rotation of the tube relative to the plate. For example, an open end cap on the elongated toothed plate may constrain the proximal and distal ends of the rigid tube while allowing rotation. A stepper motor attached to the handle rotates a wheel or gear that contacts the splined rigid tube. The surface of the wheel in contact with the rigid tube may have a textured surface or an elastic coating to increase contact friction. When the handle trigger is pressed, the toothed plate and the attached splined tube advance forward, while the splined tube rotates bidirectionally driven by the stepper motor. Alternative means of achieving tube rotation can be used. For example, reciprocating rotation can be achieved by using two electromagnets coupled to the shaft of the tube, which are activated sequentially to cause the tube to cyclically tilt in the left-right direction toward a ferromagnetic strip residing inside each handle. A third mechanism for achieving bidirectional tube rotation uses a rigid tube with a sinusoidal groove at its bottom, rotatably attached to a toothed plate with a straight groove in its central portion, and a pin fixed to the handle, protruding through the groove in the toothed plate and the sinusoidal groove in the rigid tube. The advancement of the toothed plate and the attached rigid tube relative to the pin causes the rigid tube to oscillate in a clockwise and counterclockwise cyclic rotation as it travels along the rigid pin in the sinusoidal groove.

[0016] A force limiter is provided to restrict the force applied to the distal tip of the catheter. During the advancement of the balloon catheter through the fallopian tube, if the contact force between the transparent conical tip and the inner wall of the fallopian tube exceeds a preset amount, the force limiter will prevent further catheter advancement. This prevents potential fallopian tube perforation. Force limitation for catheter advancement can be implemented via magnetic coupling of a ratchet drive mechanism. The handle trigger can include a magnet coupled to a second magnet, or an iron disk attached to a toothed drive unit that interfaces with an elongated toothed plate. When the trigger is pressed to drive the catheter forward, excessive force applied by the transparent conical tip to the fallopian tube tissue causes the magnetic interface to decouple and release. The strength of the magnetic coupling can be adjusted to produce the desired degree of force limitation. Alternatively, catheter force limitation can be provided by adding a compression spring to the trigger drive mechanism in the fallopian tube endoscope handle. At the upper limit of the desired catheter tip force, the trigger compresses the spring instead of driving the toothed plate forward.

[0017] The handle houses electronic components for processing video signals generated by an electronic imaging element, such as a CMOS chip located inside or near the tip of a tapered catheter. This imaging element is provided as part of a separate “micro-endoscope” incorporating the CMOS or other electronic imaging element. Power is supplied to the CMOS chip or electronic imaging element via a conductive cable extending along the length of the catheter near a control circuit board in the handle of the fallopian tube endoscope. The video signal acquired by the imaging element is transmitted via a second cable, coaxial with the power cable along the length of the catheter. The coaxial power and signal transmission cable may have an outer sheath made of a polymer material such as polyethylene terephthalate (PET) heat-shrink tubing, or a spirally wound coil of flat stainless steel or other metal foil tightly bound together with a PET heat-shrink outer sheath. The combined outer diameter of the coaxial conductive cable, spirally wound coil, and outer sheath is smaller than the inner diameter of the catheter, so that the CMOS chip remains stationary as the transparent tapered tip and catheter reciprocate. Furthermore, the spirally wound coil and outer sheath provide torsional stability to the coaxial conductive cable, preventing rotation of the CMOS chip and providing a stable video image. In other cases, instead of a CMOS video chip, the imaging element can be an optical fiber with a distal lens positioned for observation within a transparent conical tip that transmits the optical image to an imaging circuit within the handle.

[0018] The video monitor is integrated into the handpiece, and this monitor can pivot along the axis to allow the doctor to simultaneously view video images and the patient's anatomy.

[0019] The application of oscillating endoscopic catheters in fallopian tube cannulation is described in detail. The principle of using a bidirectional reciprocating rotating transparent tapered-tip endoscopic catheter and limiting the advance force can also be applied to other anatomical structures involving microtubular catheters or blood vessels within the body. For example, an oscillating endoscopic catheter can be advanced through the operating channel of a cystoscope instead of an angled 4mm diameter cannula, and the oscillating transparent tapered-tip catheter can be advanced retrogradely through a length of ureter to expel impacted kidney stones or dilate ureteral strictures. Another version of the device can be advanced through the operating channel of a duodenoscope and used for cannulating the pancreatic duct or cystic duct, dilating strictures in ducts, or removing impacted gallstones. Other versions of the oscillating transparent tapered-tip endoscopic catheter can be applied to blood vessels, such as arteries or veins, to recanalize occlusions caused by thrombosis or atherosclerotic disease. Occlusion of arterial or venous grafts used for vascular access in hemodialysis can also be addressed similarly. Recanalization of occluded tubular device implants can also be performed using oscillating endoscopic catheters. Ventriculoperitoneal shunts are placed for the treatment of hydrocephalus, but these shunts often become occluded over time. A vibrating, transparent, cone-tipped endoscopic catheter can be inserted laparoscopically to the length of the ventriculoperitoneal shunt and clear any occlusions within it.

[0020] The oscillating endoscopic catheter can be used as an access device for delivering endovascular stents or endovascular implants. A transparent, tapered-tip catheter from a fallopian tube endoscope or other endoscopic catheter assemblies of this invention can be used to replace the gauze cuff of the device after recanalization of an arterial or venous occlusion. The oscillating endoscopic catheter can be used for sinus endoscopy, traversing sinus stenosis, and delivering bioresorbable stents to correct occlusive stenosis. Ureteral stents can also be placed via this device.

[0021] In a first aspect, the present invention provides a fallopian tube endoscope intended for use with a hysteroscopy or other uterine endoscopic access device. The fallopian tube endoscope includes a cannula having an angled tip oriented to engage the fallopian tube when normally introduced into a patient's uterus via the cervix through a hysteroscopy. The cannula has a distal observation tip configured to be advanced from the distal end of the cannula through the cervical opening into the patient's uterus. The observation chamber has a wide proximal end attached to the distal observation tip of the cannula, and the observation chamber is at least partially transparent and generally tapered in the distal direction to provide a clear observation area for the endoscope and non-invasive advancement into the fallopian tube.

[0022] In specific embodiments, the observation chamber may be completely transparent and may include a pre-formed expandable or other shell, and / or may include a pre-formed conical shell with a narrow tip configured to allow non-invasive advancement through the lumen of the fallopian tube, while also providing a clear view of the lumen wall because the lumen wall is separated by the conical surface. In certain cases, the catheter has a diameter ranging from 0.75 mm to 1 mm, the bottom of the pre-formed shell has a bottom diameter ranging from 1 mm to 1.25 mm, and the pre-formed shell has a length ranging from 4 mm to 7.5 mm.

[0023] In addition to providing visualization of the interior of the fallopian tube lumen, the fallopian tube endoscope of the present invention may also include cell collection, tissue sampling, biopsy, or other diagnostic procedures. For example, a fabric (gauze) cuff, brush, or other cell collection element located outside the catheter is typically positioned directly proximal to the observation chamber.

[0024] The fallopian tube endoscope of the present invention typically includes a handle attached to the proximal end of a cannula, wherein the handle is configured to advance the cannula distally from the distal end of the cannula. The handle typically includes a drive assembly configured to simultaneously advance and rotate the oscillating cannula. For example, the drive assembly may include a trigger coupled to a ratchet mechanism that incrementally advances the cannula. The drive assembly typically also includes a mechanism for rotating the oscillating cannula. In one case, the mechanism includes an electrically operated rocker arm that engages and rotates the oscillating cannula or an extension of the cannula. Alternatively, the mechanism includes a pin fixed in the handle, wherein the pin travels in a sinusoidal, zigzag, or other serpentine groove formed in the outer surface of the cannula or an extension of the cannula to cause the cannula to rotate and oscillate as the cannula is advanced by the trigger and ratchet. Further alternatively, the cannula can be rotated and oscillated by coupling a pair of laterally adjacent electromagnets to the cannula or an extension thereof. By providing ferromagnetic strips on opposite sides of the handle and alternately energizing the two magnets, the cannula can be rotated alternately in opposite directions of rotation.

[0025] In a second aspect, the present invention provides a method for accessing a patient's fallopian tube. The method includes introducing the distal end of a catheter into the patient's uterus via the cervix to engage the opening of the patient's fallopian tube. A catheter having a distal observation tip is advanced from the distal end of the catheter through the opening of the patient's fallopian tube into the patient's fallopian tube. Subsequently, the catheter is non-invasively advanced through the patient's fallopian tube while observing the interior of the fallopian tube through a conical observation chamber attached to the distal observation tip of the catheter.

[0026] In a particular embodiment of the method of the present invention, the observation chamber has a wide proximal end attached to the distal observation tip of the catheter, and the observation chamber is at least partially transparent and tapered in the distal direction to provide a clear observation area for the endoscope and non-invasive advancement into the fallopian tube. The observation chamber is typically completely transparent and may include a pre-formed shell, which may also be conical. In certain cases, the catheter may have a diameter ranging from 0.75 mm to 1 mm, and the bottom of the pre-formed shell may have a bottom diameter ranging from 1 mm to 1.25 mm and a length ranging from 4 mm to 7.5 mm when expanded.

[0027] This method typically also includes diagnostic tests, such as cell collection and tissue biopsy. Specifically, the catheter can be used to collect and remove 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 certain cases, engaging the cell collection surface involves a rotating oscillating catheter, often simultaneously using a translational ratchet mechanism to incrementally advance the catheter. Attached Figure Description

[0028] Figures 1A-1B show the components of a prior art linear eversion balloon catheter used for fallopian tube endoscopy.

[0029] Figure 2 shows the eversion of the prior art balloon of Figure 1, in which the endoscope extends over the everted balloon.

[0030] Figure 3 shows the tip of a single-jaw forceps used to manipulate the cervix during the insertion of a conventional rigid hysteroscope.

[0031] Figures 4A-4B The configuration of the oscillating endoscopic catheter of the present invention for fallopian tube cannulation is shown, referred to herein as a fallopian tube endoscope.

[0032] Figures 5A-5B show that existing-technical endoscopes, arranged with linear eversion balloon catheters, cannot visualize the lumen of undilated fallopian tubes.

[0033] Figures 6A-6B The advancement of the transparent conical tip of the fallopian tube endoscope of the present invention is shown, and the dilation of the fallopian tube during its advancement is shown to enhance the visualization of the fallopian tube lumen.

[0034] Figure 7 An embodiment of the fallopian tube endoscope of the present invention is shown, which uses a trigger handle to advance the transparent conical tip of the fallopian tube endoscope distally.

[0035] Figure 8 This is an anatomical diagram depicting the components of a fallopian tube endoscope, including a reusable handle, a disposable cannula, and a disposable catheter.

[0036] Figure 9The diagram shows a conduit propulsion mechanism housed in a handle and incorporating force-limiting features.

[0037] Figures 10A-10B A handle mechanism with a releasable lock that prevents retrograde movement of the catheter is shown.

[0038] Figures 11A-11C The present invention provides a fallopian tube endoscope for rotational oscillation (reciprocating oscillation) and a mechanism having an alternative propulsion limiting mechanism.

[0039] Figures 12A-12B The alternative mechanism of the fallopian tube endoscope of the present invention is shown, which involves rotational oscillation (reciprocating oscillation).

[0040] Figures 13A-13D The third mechanism of the fallopian tube endoscope of the present invention is shown for rotational oscillation (reciprocating oscillation).

[0041] Figures 14A-14D Another alternative mechanism of the fallopian tube endoscope of the present invention is described using electromagnetically driven rotary oscillation (reciprocating oscillation).

[0042] Figure 15 The layout of the components within the handle of a manually operated oscillating endoscopic catheter used for fallopian tube cannulation is shown.

[0043] Figure 16 An exploded view of the components within the handle of a manually operated oscillating endoscopic catheter used for fallopian tube cannulation is depicted.

[0044] Figure 17 The alternative locations for the video monitor attached to the surgeon's wristband are shown.

[0045] Figure 18 The components and configuration of a manually vibrating endoscope catheter, which is incorporated into a video monitor wrist attachment instead of a device handle, are depicted. Detailed Implementation

[0046] Figure 1A shows the prior articulated catheter 10 used for fallopian tube endoscopy. The catheter 10 is everted from its distal end via the fallopian tube using a balloon 13, and the endoscope is delivered into the fallopian tube using the everted balloon. The catheter 10 is pressurized with saline, and the proximal connector 11 is manually advanced toward the distal connector 12 to evert the balloon from the distal tip of the catheter 10. Figure 1B is a cross-sectional view of the distal portion of the catheter 10, showing the distal coiled end of the inverted balloon 13 attached to the distal inner wall of the catheter 10, and the proximal end of the inverted balloon 13 attached to the distal end of the inner catheter 14. The endoscope 15 is located inside the inner catheter 14 and the inverted balloon 13.

[0047] Figure 2 depicts a linear eversion balloon catheter 10 everting a balloon 13 through the fallopian tube 16. During eversion, the balloon 13 is in a double-walled annular configuration, compressing the endoscope 15 and driving it forward at twice the speed of advancing the balloon 13. The exposed endoscope 15 may be driven against the wall of the fallopian tube 16, resulting in dissection or perforation. Therefore, fallopian tube endoscopy using the linear eversion balloon catheter 10 is performed stepwise, with eversion stopping after a short distance to decompress the catheter 10 and allow the endoscope 13 to be pulled back into the everted balloon 13 and the inner catheter 14.

[0048] Figure 3 shows the instruments required for hysteroscopy using a rigid hysteroscope 17. Tubal cannulation is also performed by inserting a guidewire and catheter through the operating channel of the hysteroscope 17 into the fallopian tubes. To insert the 5mm or 7mm diameter rigid hysteroscope 17 into the uterus 19, the sharp tip of a single-jaw forceps 19 is used to grasp and manipulate the cervix 20 during the introduction of the hysteroscope 17 into the uterus 19. The application of the single-jaw forceps 19 is very painful and usually requires anesthesia, including sedation and an injection of local anesthesia such as lidocaine into the paracervical region. A colposcope 21 is also commonly used to retrieve vaginal tissue 22 during hysteroscopy. Patients tolerate the use of the colposcope 21 to a greater extent, and its use is an integral part of the annual pelvic examination performed for the diagnosis of cervical malignancies via Pap smears.

[0049] Figure 4A The present invention describes a fallopian tube endoscopy device 23 configured to navigate the length of the fallopian tubes in a physician's office environment without causing pain or trauma to the patient or damage to the fallopian tubes. The fallopian tube endoscopy device 23 includes a cannula 24 with an outer diameter of approximately 4 mm, which is typically a rigid cannula 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 endoscopic images. The device handle 26 contains an electrically driven system that reciprocates a splined tube 28a of a catheter 28 located within the lumen of the rigid cannula 24. A transparent tapered tip 29 is attached to the distal end of the catheter 28. The transparent tapered tip 29 and the catheter 28 can be actuated by a motor driver in the handle 26, reciprocating clockwise and counterclockwise at a frequency of approximately 2-5 cycles per second with a scanning arc of up to 180°. Infusion ports 32 and 33 can be connected to allow fluid injection via device 23. If the transparent conical tip 29 is an inflatable elastic or non-elastic balloon, infusion port 32 can be incorporated with a check valve that allows the transparent conical tip 29 to expand via catheter 28. Infusion port 33 can allow fluid infusion via rigid cannula 24 for uterine dilation, thereby improving visualization of the fallopian tube opening for cannulation via transparent conical tip 29. Figure 4BThis is an enlarged view of the distal tip of the fallopian tube endoscope 23, showing the transparent conical tip 29 attached to the distal end of the catheter 28. The outer diameter of the catheter 28 is approximately 0.8 mm, and the maximum outer diameter of the transparent conical tip 29 is approximately 1.1 mm, with a length of approximately 5-10 mm. The distal tip 30 of the CMOS chip endoscope extends into the proximal portion of the transparent conical tip 29, thereby allowing visualization of the cervix, uterus, and fallopian tubes when the fallopian tube endoscope 23 is advanced into the fallopian tube opening, and allowing visualization of the fallopian tubes as the catheter 28 advances the length of the fallopian tube. The conical configuration of the transparent tip 29 is designed to retract the undilated fallopian tube wall as the catheter 28 is advanced out of the cannula 24. The distal end of the cannula 24 remains outside the fallopian tube opening. A gauze or other fabric cuff 31 is attached to the distal end of the catheter 28, immediately proximal to the transparent conical tip 29. The gaps in the gauze or other fabric cuff 31 allow for sampling from the fallopian tube and preservation of endothelial cells during insertion and removal of the catheter 28.

[0050] Figure 5A illustrates how, as the conventional endoscope 15 advances from the existing linear eversion balloon 13, the tip of the endoscope 15 rests against the tissue of the collapsed fallopian tube 16, preventing visualization of the fallopian tube lumen. Figure 5B shows a resulting endoscopic image 35 of the collapsed lumen 36 that is almost imperceptible. Due to limited imaging, continued advancement of the endoscope after balloon eversion carries the risk of fallopian tube perforation.

[0051] Figure 6A The advancement of a transparent conical tip 29 at the distal end of a duct 28 within a collapsed fallopian tube 16 is shown. The transparent conical tip 29 dilates the fallopian tube 16 and provides an observation length of approximately 7 mm of the fallopian tube lumen because the transparent conical tip 29 extends to the distal distance “X” of the tip 30 of the CMOS chip endoscope. Figure 6B The corresponding endoscopic image 35 is displayed, now showing a clearly visible open lumen 36. The transparent conical tip 29 can now be advanced into the fallopian tube lumen 16, thereby reducing the risk of perforation of the fallopian tube wall 16.

[0052] Figure 7This diagram illustrates the configuration of a fallopian tube endoscope device using a trigger 37 in the handle 26 to advance the catheter 28. Pressing the trigger 37 drives the toothed plate 38 forward. A rigid tube 40 is connected to the toothed plate 38 in a manner that allows it to rotate relative to the toothed plate 38 while constraining axial movement between them. A small-diameter rigid tube 41 extends forward from the rigid tube 39 and slides within the lumen of an angled cannula 24. The catheter 28 engages with the lumen of both 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 microendoscopy, typically a CMOS chip endoscope, extends through the lumen of the catheter 28, with its distal tip 30 residing within the transparent tapered tip 29. Video images obtained through the microendoscopy are viewed on a video display 34. A gauze cuff 31 is attached to the distal end of the catheter 28, close to the proximal end of the transparent tapered tip 29. As the catheter 28 advances or retracts along the length of the fallopian tube, the gauze cuff 31 is used to collect endothelial cells from the fallopian tube.

[0053] Figure 8 This is an anatomical diagram of the fallopian tube endoscope of the present invention, depicting a reusable handle 26 including an internal drive mechanism and a video display 34. The proximal end 24a of a disposable cannula 24 is detachably attached to the reusable handle 26. A catheter 28 is included as part of a disposable assembly comprising a toothed plate 38, a rigid tube 40, a small-diameter rigid tube 41, a transparent tapered tip 29, a gauze cuff 31, and a microendoscopy. Bearings 39 are fixed at the proximal and distal ends of the toothed plate 38 to rotatably support the rigid tube 40, allowing the assembly of the rigid tube 40, the small-diameter rigid tube 41, the transparent tapered tip 29, the gauze cuff 31, and the microendoscopy to rotate about its longitudinal axis relative to the toothed plate 38 and the handle 26. This assembly is first inserted into the reusable handle 26, and then the disposable angled cannula 24 is coaxially positioned above the transparent tapered tip 29, the catheter 28, and the small-diameter rigid tube 41 for attachment to the reusable handle 26.

[0054] Figure 9An embodiment of the drive mechanism included within the handle 26 of the fallopian tube endoscope is shown. A trigger 37 pivots on a pin 41, and a tension spring 42 returns the trigger 37 to its rest position upon actuation. A connecting rod 43 has an elongated slot 44 at its lower end, which also pivots on the pin 41. The upper or upper edge 43a of the connecting rod 43 includes teeth that mesh with teeth 38a on the lower surface of a toothed plate 38. A magnet 45 is attached to the upper part of the trigger 37 and interfaces with a ferromagnetic plate 46 attached to the connecting rod 43. When the trigger 37 is pressed (manually closed by the user), the magnet 45 pulls the toothed connecting rod 43 forward, also driving the toothed plate 38 forward. The magnetic coupling between the trigger 37 and the connecting rod 43 limits the forward driving force that can be applied to the catheter, thereby reducing the risk of fallopian tube damage. That is, the forward driving force of the toothed plate 38 is limited by the magnetic attraction between the magnet 45 and the ferromagnetic plate 46. The force-limiting mechanism of the catheter tip against the fallopian tube is determined by the magnetically coupled force in the drive unit located in the handle 26. The angle of the teeth in the toothed plate 38 and the connecting rod 43 is configured to produce forward propulsion of the toothed plate 38 when the trigger 37 is pressed. When the trigger 37 is released, the tension spring 42 pulls the trigger 37 forward and retracts the connecting rod 43 to its original position. The elongated slot 44 allows the connecting rod 43 to rest on the pin 41 and facilitates the rearward movement of its upper toothed edge against the toothed plate 38. The compression spring 47 provides resistance to the toothed plate 38 to prevent it from moving backward during the return movement of the connecting rod 43.

[0055] Figure 10A The drive mechanism of the fallopian tube endoscope handle 26 is shown. The handle 26 includes a releasable lock 48 that abuts against the toothed plate 38 to restrict it to unidirectional forward movement. Figure 10B This is an enlarged view of the releasable lock 48, showing its components, including a locking tooth 49 that is lifted by a compression spring 50 to engage with a corresponding tooth on the toothed plate 38. The locking tooth 49 can be disengaged by pressing the actuator knob 51 during insertion of the toothed plate 38 into the reusable handle 26 or during retraction of the toothed plate 38 to retract the guide tip.

[0056] Figure 11A An embodiment of the mechanism for achieving oscillating duct rotation is shown. A stepper motor (not shown) within a reusable handle 26 has an attachment gear facet 54 located outside the handle 26, which interfaces with the rigid tube 40. In this embodiment, the rigid tube 40 is splined, and the axial gear teeth on its outer surface mate with the teeth on the gear facet 54. Figure 11B This is an enlarged view of the motor drive mechanism, showing the drive gear 54 meshing with the splined gear 53 on the rigid tube 40. The arc and frequency of the guide tube's rotation can be adjusted via electronic control parameters input to the stepper motor. Figure 11CAn alternative mechanism for limiting catheter tip force is depicted. The upper portion of trigger 37 includes a linkage mechanism 55 comprising a cross pin 56, which is spring-loaded via a compression spring 57. The cross pin 56 travels along an arched groove 58 and engages with the teeth of a toothed plate 38 to generate forward movement when trigger 37 is pressed. When a set maximum catheter tip contact force is exceeded, pulling the trigger compresses the spring 57, thereby preventing the catheter from advancing forward.

[0057] Figure 12A and Figure 12B An alternative drive mechanism for rotating the oscillating conduit is depicted. A motor 59 is attached internally to the body of the handle 26. The motor 59 rotates a disc carrying a bias pin 60, which rotates continuously in a groove in a pivot mounting plate 61, causing a pendulum-like back-and-forth motion. The bottom edge of the groove plate 61 contacts the outer surface of the rigid tube 40. The bottom edge of the groove plate 61 contacts the outer surface of the rigid tube 40 with sufficient friction to cause the rigid tube 40 to oscillate about its axis. The bottom edge of the groove plate 61 may be partially or completely covered with an elastic material, such as silicone rubber or polyurethane, to enhance frictional contact. The surface of the rigid tube may be smooth, or it may contain multiple axial grooves or other surface features, or it may contain texture if additional friction is required for rotation.

[0058] Figures 13A-13D This is another mechanism used to rotate and oscillate the catheter during its advancement. A stainless steel pin 62 is anchored in the body of the handle 26. Figure 13A Pin 62 protrudes through a groove in toothed plate 38 on the bottom of rigid tube 40. Figure 13B The disposable catheter 28 component of the fallopian tube endoscope device is shown, including the toothed plate 38 and the rigid tube 40, as well as... Figure 8 As shown in B. Figure 13C This is a bottom view of the toothed plate 38, showing the groove 63 extending through the full thickness of the toothed plate 38. Figure 13D This is an enlarged view of a portion of the rigid tube 40, showing a sinusoidal groove 63 on the wall of the rigid tube 40, and a pin 62 protruding through the sinusoidal groove 63. When the trigger 37 is pressed to drive the toothed plate 38 forward, the sinusoidal groove 64 in the rigid tube 40 advances along the retaining pin 62, causing the rigid tube 40 to rotate cyclically in a clockwise and counterclockwise manner.

[0059] Figure 14A Another embodiment of the fallopian tube endoscope device with a trigger 37 is shown, which actuates a toothed link 43 to drive a toothed tubular rod 65 forward. A catheter 28 with a transparent tapered tip 29 having a protective distal tip 30 for the microendoscopy is positioned within the lumen of the toothed tubular rod 65. Figure 14BAs shown, a flange 68 attached to the conduit 28 protrudes from a groove 67 at the top of the toothed tubular rod 65. Electromagnets 69 are attached to the left and right sides of the flange 68, while ferromagnetic strips 70 are attached to the left and right halves of the handle 26 opposite to the electromagnets 69. When the toothed tubular rod 65 is driven forward by pressing the trigger 37, the left and right electromagnets 69 are activated in sequence, causing the flange 68 to rotate and oscillate the conduit 28. Figure 14C This is a side view of the toothed tubular rod 65 that houses the conduit 28 within its lumen. Figure 14D This is a cross-section of the toothed tubular rod 65 at the slot 67, showing the flange 65 attached to the top surface of the conduit 28, and the electromagnets 69 attached to the left and right surfaces of the flange 68. The slot 67 is wide enough to allow the left and right sides of the flange 65 to be offset so that the conduit 28 can rotate within an arc of approximately 120°.

[0060] Figure 15 This is a view of the device with the handle 26 opened to reveal the configuration of its internal components. A cannula 24 is permanently attached to a slotted tube 25. The slotted tube 25 is fitted into a recess 36 within the handle 26, allowing it to rotate while being constrained from axial movement. A catheter 28, containing an attached transparent tapered tip 29, is flexible enough to traverse the tortuous anatomy of the fallopian tubes. A basic rigid tube 137 is attached to the proximal portion of the transparent tapered tip catheter 28. The outer diameter of the catheter 28 is approximately 1 mm, while the outer diameter of the rigid tube 137 is 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 push the catheter 28 out of the cannula 24 with an oscillating rotational motion.

[0061] Figure 16This is an exploded view of the contents within the handle 26. A transparent, tapered tip 29 is attached to the distal end of a flexible conduit 28. Inside the flexible conduit 28 is a CMOS chip endoscope 130, consisting of a distal CMOS camera chip, flexible electronic cables, and fiber optic cables for light transmission. A section of electronic and fiber optic cable 139 extends from the proximal end of the conduit 28 for connection to a control circuit board and a light-emitting diode. The proximal segment of the flexible conduit 28 is coupled to a substantially rigid tube 137. The electronic and fiber optic cable 139 exits from a hole 138 in the rigid tube 137. The rigid tube 137 is located within a slotted tube 25, while the electronic and fiber optic cable 139 exits from 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 for a full 10 cm, thus allowing the flexible conduit 28 to traverse the length of the fallopian tube. The slot 125 includes a width of an arc around approximately 120°, allowing the rigid tube to rotate bidirectionally in either direction by approximately 60°. The slotted tube 25 falls into the recess 136 in the device handle 26. The rotary actuator 27 is located on the outside of the proximal side of the handle 26. The rotary 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 align the tip of the cannula 24 with the left or right opening of the fallopian tube.

[0062] Figure 17 An alternative embodiment of the device, in which a video monitor 133 is attached to a physician's wrist via a wristband 141, is depicted. The operator grasps the proximal portion of the cannula 24, and the internal endoscopic catheter 28 is advanced through the fallopian tube with an oscillating motion. Compared to a previous handle, the cannula 24 exhibits a smaller profile, enhancing visualization of the patient's surface anatomy during device manipulation.

[0063] Figure 18 The configuration of the device without a handle is shown. A cannula 24 is attached to a slotted tube 25, and a catheter 28, containing an attached transparent tapered tip 29, resides within the cannula 24. A basic rigid tube 137 is attached to the proximal portion of the transparent tapered tip catheter 28. A physician can grasp a knob 140 on the proximal end of the rigid tube 137 and use this knob 140 to advance the catheter 28 with an oscillating motion. An electronic and fiber optic cable 139 connects to an endoscope within the catheter 28, exiting from a hole 138 in the rigid tube 137 and a slot 125 in the slotted tube 25. An electronic and fiber optic cable 39 connects to a video monitor unit 133, which includes a wristband 141 attached to the wrist of the physician operating the device.

[0064] While the invention has been described herein with reference to certain illustrated embodiments, those skilled in the art will recognize and understand that it is not so limited. Instead, numerous additions, deletions, and modifications to the illustrated embodiments can be made without departing from the claimed scope of the invention, including its legal equivalents. Furthermore, features from one embodiment can be combined with features from another embodiment while still being included within the scope of the invention as contemplated by the inventors. Moreover, the embodiments of this disclosure are practical in various tool types and configurations.

Claims

1. A fallopian tube endoscope, comprising: A cannula having an angled tip that is oriented to engage the opening of the fallopian tube when the cannula is inserted into the patient's uterus via the cervix. A catheter having a distal observation tip configured to be advanced from the distal end of the catheter through the cervical opening into the patient's uterus; An observation chamber having a wide proximal end attached to the distal observation tip of the catheter, wherein the observation chamber is at least partially transparent and tapered in the distal direction to provide a clear observation area for the endoscope and non-invasive advancement into the fallopian tube; A cell collection element located outside the catheter proximal to the observation chamber, the cell collection element comprising a fabric cuff with a gap configured to sample and retain cells collected from the fallopian tube during catheter advancement and retraction; and A force-limiting mechanism, associated with the advancement of the catheter, is configured to prevent further advancement of the catheter by magnetically decoupling when the contact force exerted by the distal viewing tip of the catheter on the inner wall of the fallopian tube exceeds a preset amount, thereby preventing perforation of the fallopian tube. The proximal end of the catheter includes a knob configured to be manually grasped by a user to advance the catheter in an oscillating manner, and the oscillating advance of the catheter drives the reciprocating rotation of the cell collection element to assist in cell collection.

2. The fallopian tube endoscope according to claim 1, wherein the observation chamber is completely transparent.

3. The fallopian tube endoscope according to claim 1, wherein the observation chamber comprises a pre-formed, expandable outer shell.

4. The fallopian tube endoscope according to claim 3, wherein the pre-formed outer shell is conical.

5. The fallopian tube endoscope according to claim 4, wherein the catheter has a diameter range from 0.75 mm to 1 mm, the bottom of the preformed shell has a bottom diameter range from 1 mm to 1.25 mm and a length range from 4 mm to 7.5 mm when expanded.

6. The fallopian tube endoscope of claim 1 further includes a handle attached to the proximal end of the cannula and configured to advance the cannula distally from the distal end of the cannula.

7. The fallopian tube endoscope of claim 6, wherein the handle includes a drive assembly configured to simultaneously advance and rotate the catheter.

8. The fallopian tube endoscope of claim 7, wherein the drive assembly includes a trigger coupled to a ratchet mechanism configured to incrementally advance the catheter.

9. The fallopian tube endoscope of claim 8, wherein the drive assembly further comprises an electrically operated rocker arm that engages and rotates the catheter or an extension thereof.

10. The fallopian tube endoscope of claim 8, wherein the drive assembly further comprises a pin fixed in the handle, wherein the pin travels in a serpentine groove formed in the outer surface of the catheter or in an extension of the catheter to cause the catheter to rotate and oscillate when the catheter is advanced by the trigger and ratchet.

11. A fallopian tube endoscope, comprising: A cannula having an angled tip that is oriented to engage the opening of the fallopian tube when the cannula is inserted into the patient's uterus via the cervix. A catheter having a distal observation tip configured to be advanced from the distal end of the catheter through the cervical opening into the patient's uterus; An observation chamber having a wide proximal end attached to the distal observation tip of the catheter; A cell collection element located outside the catheter proximal to the observation chamber, the cell collection element comprising a fabric cuff with a gap configured to sample and retain cells collected from the fallopian tube during catheter advancement and retraction; and A force-limiting mechanism, associated with the advancement of the catheter, is configured to prevent further advancement of the catheter by magnetically decoupling when the contact force exerted by the distal viewing tip of the catheter on the inner wall of the fallopian tube exceeds a preset amount, thereby preventing perforation of the fallopian tube. The catheter is translatably and rotatably received within the lumen of the cannula, and the proximal end of the catheter is configured to be manually grasped by a user to allow manual translation and rotation with tactile feedback. The proximal end of the catheter includes a knob configured to be manually grasped by a user to advance the catheter in an oscillating manner, and the oscillating advance of the catheter drives the reciprocating rotation of the cell collection element to assist in cell collection.

12. The fallopian tube endoscope of claim 11, wherein the observation chamber is at least partially transparent and tapered in the distal direction to provide a clear observation area for the endoscope and non-invasive advancement into the fallopian tube.

Images