Device and method for everting catheter for iud delivery and arrangement in uterine cavity

[0001] This application claims priority to U.S. Provisional Patent Application No. 62/913,160, filed October 9, 2019. This application is incorporated herein by reference in its entirety.

[0002] The devices and methods disclosed herein are useful for everting catheters characterized by an inner catheter, an outer catheter, and an everting membrane that can be connected to both catheters. may have a sexual nature. The inner catheter may include a lumen for passing fluids or media, drugs or therapeutics, instruments or devices, such as intrauterine devices (IUDs), endoscopes, and other catheters.

[0003] For physicians and medical professionals, systems for accessing a patient's vessels and body cavities typically employ a variety of guidewire and catheter technologies. In some cases, this process requires the insertion of a series of mandrels or wires to enlarge the diameter of the lumen in order to ultimately pass larger diameter instruments into the vessel. This technique is sometimes called "Dottering." Alternatively, when accessing the cervix and uterus, the physician uses a series of diameter-enlarging mandrels known as Heger dilators. In the techniques described above, the method involved pushing an object, mandrel, or device into a vessel to access the desired area within the body. Pushing the object, mandrel, or device results in shear forces against the lumen wall. In some cases, this shearing force can cause trauma and pain to the patient, or can cause perforation.

[0004] In contrast, another access technique used in the prior art is called an everting catheter. An everting catheter is a transverse catheter in which the balloon is inverted and is rolled inside out or everted by a propulsive force within the vessel under the influence of water pressure generated by a compressible or incompressible fluid or medium. Use traversing action. The everting balloon is a rolling balloon or an outrolling balloon, an evaginating membrane, a toposcopic catheter. For example, US Pat. No. 5,364,345, US Pat. No. 3,421,509 and No. 3,911,927. All of these are incorporated herein by reference in their entirety. These are classified as everter balloons and are intended for frictionless traversal of vessels, body cavities, tubes, or ducts. In other words, the everting balloon can traverse the tube without applying shear forces to the wall it is traversing. Because of this action, and the absence of shear forces, the resulting trauma can be reduced and the risk of perforation can be reduced. Furthermore, as a result of the intravascular advancement mechanism, material within the tube or proximal portion of the vessel is not pushed or advanced forward toward the distal portion of the tube or vessel.

[0005] Additionally, when the everting catheter is everted, uncontaminated or untouched balloon material is placed inside the vessel wall. In the inverted or undeployed state, the balloon and IUD are contained within the catheter body and cannot come into contact with the patient or physician. When the balloon is pressurized and everted, the balloon material rolls inside out without contacting any elements of the extravascular portal. In delivery of the IUD, the everting action of the balloon material prevents the IUD from contacting elements in the patient's vaginal wall, exocervix, cervix, and, depending on the depth of insertion, the internal cervical os. Another advantage of everting balloon catheters is that the access method is painless for the patient. This is because the hydraulic force "pulls" the balloon membrane within the vessel or conduit, as opposed to a standard catheter that must be "pushed" into the vessel or conduit. In IUD delivery, hydraulic force forces the balloon membrane and "Pull" the IUD.

[0006] The methods typically used by physicians to access a woman's cervix require the use of multiple instruments of increasing diameter in order to access the uterine cavity with larger devices. The physician uses a small uterine probe or small diameter probe or Hegar device to initially enter the uterus through the cervix. Using the size expansion of the Hegar device, stretch the neck muscles until the desired internal diameter is achieved for insertion of a secondary instrument such as an endoscope or other device. This process can be particularly difficult for some nulliparous women who are trying to use an IUD to prevent pregnancy, or who choose to use a hormonal IUD to reduce abnormal bleeding. There may also be postmenopausal women whose cervical canal is extremely small. Crossing the neck can be difficult as a result of previous surgery, underlying stenosis, or other anatomical configurations or torsions that make it difficult for instruments or Hegar dilators to pass.

[0007] Some cervical dilators expand radially to open the cervical canal and increase the inner diameter without inserting multiple instruments. All of these devices rely on first crossing or traversing the cervical canal before the radial expansion step. Once the cervical canal has been crossed, these devices use concentric mechanical means or expansion of a balloon dilation member external to the dilator probe. If the cervix is particularly tight or narrow, a small diameter probe or mandrel may first be needed to cross the cervix to access the uterine cavity. The smaller the diameter of the mandrel or instrument, the greater the possibility of perforation or false passage. In any case, these cervical dilators require the first probe to pass or traverse them before performing radial dilation.

[0008] Everting catheters have been described as dilation catheters. Representative examples of dilatation everter catheters include US Pat. Nos. 5,364,345 and 4,863,440. Both are incorporated herein by reference in their entirety.

[0009] Everting catheters have also been described with additional elements such as handles for controlling instruments within the everting catheter. A representative example is US Pat. No. 5,346,498, which is incorporated herein by reference in its entirety. Everting balloon catheters can be constructed with an inner catheter having a lumen or a through-lumen or thru-lumen. The through lumen can be used to pass instruments, media, substances, therapeutic agents, endoscopes, guidewires, or other instruments or devices. Representative samples of everting catheters with through lumens are US Pat. Nos. 5,374,247 and 5,458,573. Additionally, everting catheters have been described with constrictions or constrictions in the balloon diameter, such as in US Pat. No. 5,074,845, which is hereby incorporated by reference in its entirety.

[0010] Abduction catheters are particularly useful for accessing the uterine cavity when the cervix is narrowed, tortuous, or has a cesarean scar or other condition that makes it difficult for the physician to pass instruments. This may include the presence of anatomical configurations. This can be an uncomfortable procedure for the patient.

[0011] One common gynecological procedure is temporary birth control techniques, or drug treatment with intrauterine devices that elute hormone treatments for abnormal uterine bleeding, menstrual pain, or implants into the uterine cavity. The idea is to place an IUD in women who are seeking other medications that can be implanted. IUDs can contain copper and can be configured into many configurations. In all of these cases, the physician must place the device in the uterine cavity.

[0012] To place the IUD in the uterus, the IUD insertion device consists of a fairly stiff tube or cannula for insertion. The IUD implant itself can be configured in a "T" or "Y" configuration in its unfolded natural state, with the three arms of the "T" or "Y" constructed as rigid members that can be bent. but does not bend easily to tight radii less than 0.500 inch. The "T" or "Y" configuration is necessary to maintain the IUD within the uterine cavity during a woman's daily or more vigorous activities, such as exercise, coughing, and uterine contractions that occur during menstruation. . In these situations, a "T" or "Y" shape is required to prevent release or migration from the uterine cavity. This is because the "T" or "Y" arms are designed to hold the IUD close to the patient's uterine fundus with the rounded ends close to the corners of the uterine cavity. Not all IUDs are "T" or "Y" shaped, and other configurations are known or commercially available, including circular or helical shapes.

[0013] In clinical applications, during device placement, the cervix may have multiple turns and curvatures, including tight radius curves. As it is placed through the cervix, the physician grasps the cervix and maintains counter-traction against it to straighten the cervix and reduce the amount of curvature. In addition to straightening the cervix, countertraction facilitates pushing the IUD insertion device through the cervix and into the uterine cavity. Misplacement, perforation, or inability to deploy an IUD are all known and generally accepted consequences or adverse events in IUD placement procedures. The stiffness of the cannula or IUD implant itself also causes patient discomfort during the placement procedure. This is especially true in women with cervical stenosis or nulliparous women.

[0014] Once the IUD is properly positioned in the patient, the cannula of the IUD insertion device is attached to a handle that allows the physician to translate the IUD from the distal end of the cannula. The handle allows the physician to perform the placement procedure with one hand.

[0015] After placing the IUD in the uterine cavity, the IUD insertion device is withdrawn from the patient. When the insertion device slides out of the cervix, the IUD's retrieval suture or sutures remain within the patient's cervix. Once removed, the physician trims any visible excess suture extending from the cervicovaginal region. The IUD sutures extend from the cervicovaginal region and are visible within the patient's vagina, so the excess can be trimmed to the length indicated on the IUD manufacturer's label.

[0016]

[0017] Additionally, when delivering IUDs, instruments, devices, and reproductive material, such as embryos, into the uterine cavity, the access system may force cervical mucus and material from the vagina into the uterine cavity. These fluids and substances from the vagina can promote bacterial infections. The action of expanding the balloon is designed to minimize this effect.

[0018] Additionally, the access system for the uterine cavity may create a vacuum effect when withdrawn or removed from the uterine cavity. This vacuum effect can unintentionally remove reproductive material from the uterine cavity in the context of embryo transfer. In existing systems, when an implantation catheter is retracted from a second outer or guide catheter (eg, an "inner" catheter), this retraction creates a vacuum pressure within the uterine cavity. This vacuum pressure is created within the uterine cavity by removal and retraction of the implanted catheter within the inner catheter. After the embryo transfer is complete, the embryologist inspects the transfer catheter to verify that the embryo or reproductive material was indeed placed within the uterus and was not pulled back into the transfer catheter by a vacuum effect. Once this catheter is removed, the same procedure can be performed on the outer catheter. Having a system that can reduce vacuum effects in IUD placement may result in more reliable and accurate IUD placement.

[0019] Also, in the motion exhibited by an everting balloon, the balloon is in an inverted state, and under the influence of water pressure caused by a compressible or incompressible fluid or medium, its driving force causes it to roll inside out, or abduct. do. The everting balloon is also referred to as a rotating balloon or external rotating balloon, everting membrane, toposcope catheter, or linear everting balloon. All of these are classified as everting balloons due to their ability to traverse a vessel, body cavity, canal, or conduit in a substantially frictionless manner. The everting balloon can traverse the tube without imposing significant shear forces on the wall it is traversing. Because of this action, and because there is no shear force, material within the proximal portion of the tube or vessel is not pushed or advanced forward toward the distal portion of the tube or vessel. For example, with eversion balloons in the female genital tract, potential infection from the vagina, os or cervicovaginal region, or the patient's arms or other anatomical structures, and the physician's hands during insertion or catheter preparation. Sexual substances do not contact the everted balloon within the catheter system prior to deployment within the patient. The purpose of keeping the everting balloon isolated from potentially unclean surfaces is to reduce post-procedure infection.

[0020] An everting balloon system is disclosed. Abduction balloon systems can be used for IUD placement, instrument, device, and endoscope delivery, and for insemination, urinary incontinence, body cavity expansion, intrabody cavity access and sealing, or combinations thereof. . The system may have automatic deployment and disengagement. The system may have a handle for insertion. The system may have a motorized air or fluid pump or a pressurized source. The system may have an inner catheter and an outer catheter that can automatically disengage upon abduction.

[0021] An everting balloon system may have an intubation base with a fixed balloon that can be activated upon pressurization. The system can be a compact, low-profile unit for use in vivo. The system can be disposable, used only once. The system can be non-inflammatory and non-infectious.

[0022] Abduction balloon systems can be used for cervical access, dilation, and delivery of IUDs. The everting balloon system may have a system handle mechanism that allows for one-handed operation techniques by the user. A one-handed operation technique may involve advancing and pressurizing the everting balloon membrane within the control of a user with one hand.

[0023] The everting balloon system can be used for insertion of drug delivery devices or insemination, sealing the cervix for a period of time for placement of drugs or sperm and to provide patient mobility. be able to. The everting balloon system may have a separation mechanism configured to separate the outer catheter and the inner catheter while maintaining water pressure within the everting balloon. The system can simultaneously deflate and remove the everting balloon.

[0024] The system can be used to place or deliver a fallopian tube insert (ie, an intrafallopian insert such as Bayer Corporation's Essure device) into the fallopian tube. The system can access the interior of the fallopian tube wall and isthmus. The abduction catheter system, in whole or in part, can be loaded into a hysteroscope and positioned using direct endoscopic visualization.

[0025] The everting catheter system can be a selective fallopian catheter with a curved distal end and a beveled ball tip. This configuration can be performed by ultrasound or by X-ray imaging.

[0026] One or more fallopian tube occlusion devices (eg, an Essure device) can be loaded within the everting balloon system, eg, into the through lumen of the inner catheter. Once fully everted and positioned within the fallopian tube, the everting balloon system, such as an inner catheter, can be withdrawn from the fallopian tube while leaving the fallopian tube occlusion device within the fallopian tube. Once the everting balloon system is withdrawn from the fallopian tube, the fallopian tube occlusion device can be deployed (e.g., by stretching the device anchorage, such as a coil, or by inflating an elastic porous matrix to create friction against the lumen). ). After deploying the fallopian tube occlusion device, the central guide wire can be removed from the fallopian tube. This procedure can be repeated on the opposite fallopian tube.

[0027] The everting balloon system can be used to access the bladder, ureters, kidneys, or a combination thereof. Devices, tools, instruments, endoscopes, drugs, therapeutic agents, sampling devices (brushes, biopsies, and aspiration mechanisms), or combinations thereof, can be delivered to the target site via the inner catheter lumen.

[0028] Also disclosed herein are specialized abduction catheter systems in which certain instruments, tools, or features are constructed or arranged within the abduction catheter system. Examples of such tools or instruments include biopsy devices, cytology devices, drug delivery mechanisms, fluid delivery mechanisms, endoscopes, IUDs, or potential Other tools that are delivered to body spaces or vessels within the body are included. There are several advantages to constructing or placing an IUD within an everting catheter system as a delivery mechanism. The abduction balloon can be used to pull the IUD implant into the uterine cavity without requiring the physician or operator to push the insertion device through the cervicovaginal region into the uterine cavity. This is particularly useful in tortuous or narrow necks. Additionally, the everting membrane rolls inside out within the passageway without imparting shear forces to the lumen walls and without friction. The everting balloon functions to protect the body passageway from the distal end profile of the IUD while pulling the IUD into the desired position.

[0029] The IUD can be secured to the abduction catheter system and automatically extend beyond the distal end of the abduction balloon by being pulled into the uterine cavity by the abduction balloon. During the abduction process, the IUD can be shielded from body tissue until it extends beyond the distal end of the abduction balloon. In this process, the IUD does not come into contact with the vagina, the cervicovaginal region, or other fluids, mucus, or tissues in the proximal region of the cervicovaginal region. Providing the IUD at a specific distance within the abduction catheter system allows the physician to guide the IUD a precise distance from a specific location within the cervicovaginal or uterine cavity.

[0030] IUD placement procedures can be performed or delivered at specific locations within the uterine cavity.

[0031] The everting membrane for IUD placement can be designed for one-handed placement.

[0032] The everting membrane for IUD placement can be designed for one-handed placement with automatic negative pressure during release of the IUD.

[0033] The everting membrane for IUD placement can be designed for one-handed placement with automatic or manual irrigation through the central lumen during release of the IUD. Autoperfusion can assist device placement by releasing the IUD from the everting membrane. Irrigation through the central lumen prior to loading the IUD within the abduction catheter or delivery and release of the IUD within the abducens membrane may increase lubricity within the abducens membrane or the IUD by increasing The IUD can slide out of the everting membrane with little friction. It is particularly useful to include perfusion capabilities in abduction catheters for IUD delivery and placement. This is because the hormonal drugs, coatings, or other therapeutic agents included in some IUDs can become sticky when they interact with the surfaces of certain polymers that are useful in catheter manufacturing.

[0034] The perfusion mechanism, whether performed automatically or manually, can be inserted into the uterus using ultrasound, fluoroscopy, or direct endoscopic visualization through the central lumen of the IUD insertion device. It can be used to aid in intraluminal device visualization. As an example, injecting saline via a perfusion mechanism through the central lumen allows the physician to perform ultrasound visualization of the IUD within the uterine cavity to confirm IUD placement in a slightly distended uterine cavity. .

[0035] The IUD system may have a transfer mechanism that facilitates loading a commercially available or second party IUD into an abduction catheter. Once the IUD is loaded, the abduction catheter is ready to be placed within the patient's uterus. The delivery mechanism includes a loading device to retrograde load the second IUD onto the distal end of the everting membrane and a loading device for capturing and retracting the IUD suture through the central lumen of the everting catheter. Including snare. The entire mechanism is housed within a flat stand that is attached to a standard procedure prep table. In operation, the loading mechanism can facilitate loading the second party IUD within the abduction catheter prior to delivery into the patient.

[0036] The everting catheter system for IUD placement procedures can be assisted by a suction system to hold onto the device during the initial steps of device loading. The suction system can operate in conjunction with the distal opening of the pusher through the central lumen of the everting catheter to stabilize and pull the IUD into position by the everting membrane of the everting catheter system.

[0037] The everting catheter system for IUD placement procedures may utilize a translatable outer catheter with a telescoping section that provides selective insertion depth within the uterine cavity for IUD device placement. The telescoping section of the outer catheter allows the insertion depth of IUD placement to be independently changed and selected without changing other components of the abduction catheter system.

[0038] The distal end of the abducens membrane at the location of the IUD is an echogenic marker for improved ultrasound contrast, visibility, and detection within the patient's uterus, or for improved real-time visualization of IUD placement. marker).

[0039] The IUD loading system allows a user to load a separately supplied IUD into the abduction catheter system. The loading system may include a cradle, split tube, and tray fixture to facilitate loading the IUD into the abduction catheter system.

[0040] Another embodiment uses a derivation of the loading system within the manufacturing process during construction of the abduction system that is integral with the preloaded IUD.

<figref num="1A">[0041] FIG. 12 is a longitudinal cross-sectional view of the distal end of a variation of the method for using an everting balloon system.</figref><figref num="1B">[0041] FIG. 12 is a longitudinal cross-sectional view of the distal end of a variation of the method for using an everting balloon system.</figref><figref num="1C">[0041] FIG. 12 is a longitudinal cross-sectional view of the distal end of a variation of the method for using an everting balloon system.</figref><figref num="1D">[0041] FIG. 12 is a longitudinal cross-sectional view of the distal end of a variation of the method for using an everting balloon system.</figref><figref num="1E">[0041] FIG. 12 is a longitudinal cross-sectional view of the distal end of a variation of the method for using an everting balloon system.</figref><figref num="2A">[0042] A variation of the abduction balloon system in a fully abducted configuration is shown.</figref><figref num="2B">[0043] FIG. 4 is a cross-sectional view of a modification of the system handle.</figref><figref num="3A">[0044] FIG. 7 illustrates a deformation of the distal end of the everting balloon system in a configuration in which the dilatation balloon is not fully inflated.</figref><figref num="3B">[0045] FIG. 7 illustrates a deformation of the distal end of the everting balloon system with the dilatation balloon in a fully inflated configuration.</figref><figref num="4A">[0046] FIG. 7 illustrates a variation of the everting balloon system in a configuration with a syringe attached but not yet deployable.</figref><figref num="4B">[0047] FIG. 7 illustrates a variation of the everting balloon system in a deployable configuration with a syringe attached.</figref><figref num="4C">[0048] FIG. 4B shows a variation of the everting balloon system of FIG. 4B in which the plunger driver is shown in cutaway view.</figref><figref num="5A">[0049] The length of deformation of the everting balloon system is shown.</figref><figref num="5B">[0050] FIG. 5B is a partial cross-sectional view of a variation of the system of FIG. 5A.</figref><figref num="5C">[0051] This is a modification of a side view of a part of the AA cross section.</figref><figref num="5D">[0051] This is a modification of a partial perspective view of the AA cross section.</figref><figref num="5E">[0052] FIG. 4 is an exploded view of a variation of a portion of the system handle and drive gear.</figref><figref num="5F">[0053] FIG. 4 is an enlarged view of the deformation of the system handle on the ratchet handle axis.</figref><figref num="6A">[0054] FIG. 4 is a cross-sectional view of a modification of the system handle.</figref><figref num="6B">[0055] FIG. 6B is a side view of a variation of the everting balloon system using the system handle of FIG. 6A.</figref><figref num="6C">[0055] FIG. 6B is a top perspective view of a variation of the everting balloon system using the system handle of FIG. 6A.</figref><figref num="6D">[0055] FIG. 6B is a cross-sectional view of a variation of the everting balloon system using the system handle of FIG. 6A.</figref><figref num="7A">[0056] FIG. 4 is an exploded view of a variation of the everting balloon system.</figref><figref num="7B">[0056] FIG. 4 is a perspective view of a variation of the everting balloon system.</figref><figref num="8A">[0057] FIG. 14 is a cross-sectional view of a variation of a three-way connector and adjacent elements configured to deliver media pressure to an outer catheter, eg, an everting balloon.</figref><figref num="8B">[0058] FIG. 12 is a cross-sectional view of a variation of a three-way connector and adjacent elements configured to deliver media pressure to an inner catheter, eg, to a dilatation balloon.</figref><figref num="9">[0059] FIG. 4 is an exploded view of a variation of the implantation catheter.</figref><figref num="10A">[0060] Variations in methods for delivering substances to target sites are shown, such as delivering reproductive substances into the uterine cavity.</figref><figref num="10B">[0060] Variations in methods for delivering substances to target sites are shown, such as delivering reproductive substances into the uterine cavity.</figref><figref num="10C">[0060] Variations in methods for delivering substances to target sites are shown, such as delivering reproductive substances into the uterine cavity.</figref><figref num="11A">[0061] Variations in methods for delivering substances to target sites are shown, such as delivering reproductive substances into the uterine cavity.</figref><figref num="11B">[0061] Variations in methods for delivering substances to target sites are shown, such as delivering reproductive substances into the uterine cavity.</figref><figref num="11C">[0061] Variations in methods for delivering substances to target sites are shown, such as delivering reproductive substances into the uterine cavity.</figref><figref num="12A">[0062] FIG. 7 illustrates an everting catheter for performing an IUD placement procedure with an everting membrane.</figref><figref num="12B">[0062] FIG. 7 illustrates an everting catheter for performing an IUD placement procedure with an everting membrane.</figref><figref num="12C">[0062] FIG. 7 illustrates an everting catheter for performing an IUD placement procedure with an everting membrane.</figref><figref num="12D">[0062] FIG. 7 illustrates an everting catheter for performing an IUD placement procedure with an everting membrane.</figref><figref num="12E">[0062] FIG. 7 illustrates an everting catheter for performing an IUD placement procedure with an everting membrane.</figref><figref num="13A">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="13B">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="13C">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="13D">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="13E">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="13F">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="13G">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="13H">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="13I">[0063] FIG. 12 illustrates in side view the distal end of the everting membrane and additional derivatives incorporated into the inner catheter.</figref><figref num="14A">[0064] FIG. 12 shows another embodiment demonstrating advancement and release of an IUD within the everting membrane.</figref><figref num="14B">[0064] FIG. 12 shows another embodiment demonstrating advancement and release of an IUD within the everting membrane.</figref><figref num="14C">[0064] FIG. 12 shows another embodiment demonstrating advancement and release of an IUD within the everting membrane.</figref><figref num="14D">[0064] FIG. 12 shows another embodiment demonstrating advancement and release of an IUD within the everting membrane.</figref><figref num="15A">[0065] FIG. 7 illustrates an automatic one-handed abduction mechanism for IUD placement.</figref><figref num="15B">[0065] FIG. 7 illustrates an automatic one-handed abduction mechanism for IUD placement.</figref><figref num="15C">[0065] FIG. 7 illustrates an automatic one-handed abduction mechanism for IUD placement.</figref><figref num="15D">[0065] FIG. 7 illustrates an automatic one-handed abduction mechanism for IUD placement.</figref><figref num="16A">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16B">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16C">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16D">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16E">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16F">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16G">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16H">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16I">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="16J">[0066] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17A">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17B">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17C">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17D">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17E">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17F">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17G">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17H">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="17I">[0067] FIG. 7 illustrates a variation of an everting catheter that can deliver an IUD into the uterine cavity.</figref><figref num="18A">[0068] A mechanism for automatically applying negative pressure during the IUD release step of the delivery process is shown. Additionally, irrigation through the central lumen can be performed separately or in conjunction with negative pressure to assist in the IUD release step.</figref><figref num="18B">[0068] A mechanism for automatically applying negative pressure during the IUD release step of the delivery process is shown. Additionally, irrigation through the central lumen can be performed separately or in conjunction with negative pressure to assist in the IUD release step.</figref><figref num="18C">[0068] A mechanism for automatically applying negative pressure during the IUD release step of the delivery process is shown. Additionally, irrigation through the central lumen can be performed separately or in conjunction with negative pressure to assist in the IUD release step.</figref><figref num="19A">[0069] FIG. 7 illustrates an abduction catheter system for delivering an IUD.</figref><figref num="19B">[0070] FIG. 3 is an enlarged view of the abduction catheter system.</figref><figref num="19C">[0070] FIG. 3 is an enlarged view of the abduction catheter system.</figref><figref num="19D">[0070] FIG. 3 is an enlarged view of the abduction catheter system.</figref><figref num="20A">[0071] FIG. 7 shows the abduction catheter system after complete abduction of the balloon in the process of delivering the IUD.</figref><figref num="20B">[0072] FIG. 4 is an enlarged view of the everted distal end of the balloon and IUD.</figref><figref num="20C">[0073] FIG. 7 shows an enlarged view of the proximal portion of the abduction catheter system after complete eversion in the process of delivering the IUD.</figref><figref num="21A">[0074] FIG. 7 illustrates the process of delivering an IUD within a simulated uterine cavity model.</figref><figref num="21B">[0074] FIG. 7 illustrates the process of delivering an IUD within a simulated uterine cavity model.</figref><figref num="21C">[0074] FIG. 7 illustrates the process of delivering an IUD within a simulated uterine cavity model. [0075]</figref><figref num="22A">[0076] FIG. 7 illustrates a packaging configuration for shipping and loading of an everting catheter system for delivering an IUD.</figref><figref num="22B">[0076] FIG. 7 illustrates a packaging configuration for shipping and loading of an everting catheter system for delivering an IUD.</figref><figref num="22C">[0076] FIG. 7 illustrates a packaging configuration for shipping and loading of an everting catheter system for delivering an IUD.</figref><figref num="22D">[0076] FIG. 7 illustrates a packaging configuration for shipping and loading of an everting catheter system for delivering an IUD.</figref><figref num="22E">[0076] FIG. 7 illustrates a packaging configuration for shipping and loading of an everting catheter system for delivering an IUD.</figref>

[0077] An abduction balloon system 2 (also referred to as an abduction catheter system) is disclosed that may be used to traverse a vessel, such as the cervical canal. The everting balloon system 2 can be used to access the uterine cavity via the cervix. The cervical canal is a single-lumen vessel that can be lengthened or dilated. The everting balloon system 2 may have a control system that can be operated with one hand. The everting catheter system can also traverse other locations within the body of a patient or animal for the purpose of placing a device within a body cavity or lumen.

[0078] FIGS. 1A to 1E show that everting catheter system 2 may have a radially outer catheter 4, a balloon membrane 6, and a radially inner catheter 8. Inner catheter 8 may have an inner catheter lumen 10 (eg, a through lumen). The distal end of inner catheter lumen 10 may be open or closed. Inner catheter 8 has an inner catheter lumen 10 or can be a solid rod or flexible mandrel. The everting balloon system 2 may have a media volume of 12. Media volume 12 may be a continuous open volume between inner catheter 8 and outer catheter 4 proximal to balloon membrane 6. The radially outer circumference of the balloon membrane 6 can be attached to the distal end of the outer catheter 4. The radially inner outer circumference of balloon membrane 6 can be attached to the distal end of inner catheter 8. It is also possible to make the everting balloon system 2 without an inner catheter 8, such that the balloon membrane 6 extends proximally from the working area to a control device (eg, a pump).

[0079] FIG. 1A shows that everting catheter system 2 can be in a non-pressurized configuration. Media volume 12 may be unexpanded and unpressurized. The balloon membrane 6 may be in a loose state.

[0080] FIG. 1B shows that everting catheter system 2 can be in a pressurized, non-everting configuration. A pressurizing device, such as a pump at the proximal end of everting catheter system 2 , may be in fluid communication with media volume 12 . The pressurization device compresses a fluid medium, such as a pneumatic gas or a hydraulic liquid medium (e.g., saline, water, air, carbon dioxide, or a combination thereof), into a medium volume 12 at a medium pressure 14. Can be sent. The medium pressure 14 within the everting balloon 2 can be about 2 to about 5 atmospheres when in an everting configuration. For example, higher media pressures 14 of about 5 to about 10 atmospheres are possible to increase abduction function for more difficult or constricted body passages.

[0081] The balloon membrane 6 may be inflated and become taut. Balloon membrane 6 can occlude the distal portion of inner catheter lumen 10.

[0082] FIG. 1C shows that the everting catheter system can be in an expanded, partially everted configuration. Inner catheter 8 can be translated distally relative to and out of outer catheter 4, as indicated by arrow 16. The distal end of inner catheter 8 may be proximal to the distal end of balloon membrane 6. The distal end of inner catheter 8 may be proximal or distal to the distal end of outer catheter 4. Balloon membrane 6 can occlude the distal portion of inner catheter lumen 10 or be open to allow fluid communication between inner catheter lumen 10 and the target site.

[0083] FIG. ID shows that the everting catheter system can be in an expanded, fully everted, fully distally extended configuration. Inner catheter 8 is moved distally relative to outer catheter 4 until the distal end of inner catheter 8 longitudinally terminates over or with the distal end of balloon membrane 6, as indicated by arrow 16. can be translated in parallel. The distal portion of the inner catheter lumen 10 is unobstructedly accessible and can be in fluid communication with the target site.

[0084] In a fully inflated configuration, balloon membrane 6 may form an inflated everting balloon 18. The everting balloon 18 may have an outer balloon diameter 20 and a balloon length 22 in the inflated, fully everted configuration.

[0085] The balloon outer diameter 20 can be about 2 mm to about 20 mm, and in a narrower range about 2 mm to about 7 mm, for example about 5 mm. The outer diameter may be constant or vary along the length of everting balloon 18. For example, for cervical use, the proximal-most portion of everting balloon outer diameter 20 may be configured with a smaller outer diameter than the remaining portion of everting balloon membrane 24. By way of example, the first proximal portion of everting balloon 18 may have a small outer balloon diameter 20, such as about 2 mm to 4 mm, over a length of about 5 mm to about 10 mm from the distal end of outer catheter 4. The remainder of the length of everting balloon 18 (eg, about 4 cm to about 7 cm along everting balloon 18) may have an outer balloon diameter 20 of about 4 mm to about 7 mm. The outer diameter of the proximal end of everting balloon 18 has a consistent outer diameter 20 of about 3 mm to about 6 mm for delivery in the cervix or urethra, and the outer diameter of the proximal end of everting balloon 18 is about 2 cm to about 3 cm. The distal exterior may have a balloon outer diameter 20 of from about 10 mm to about 20 mm, for example to seal and secure the internal os of the uterine cavity or the bladder.

[0086] The outer surface of the balloon membrane 6 may include ridges, protrusions, bumps, grooves, etc., for example to increase friction or retention within the vessel, or to capture body fluids, cells, or tissues. and additional surface or mechanical features, or combinations thereof.

[0087] Abduction balloon length 22 can be from about 2 cm to about 31 cm, with an even narrower range of about 2 cm to about 25 cm (for example, when used in the male urethra), and an even narrower range of about 2 cm to about 12 cm for IUD placement. , in vitro fertilization, insemination procedures, or instrument and endoscopic delivery may have even narrower ranges from about 3 cm to about 6 cm, such as about 4 cm, about 7 cm, about 15 cm, and about 30 cm.

[0088] FIG. 1E shows that the everting catheter system can be inflated and in a partially or fully everted configuration. Translating a device or tool 26, a liquid, a gas, or a combination thereof, through the inner catheter lumen 10 and from the distal portion of the inner catheter lumen 10 to the target site, as indicated by arrow 28. can be done. Tool 26 can be an IUD, biopsy tool, scope, sonogram probe, plug, ablation tool, or a combination thereof. Suction can be applied to the target site from the proximal end of the inner catheter lumen 10 to remove debris from the target site, eg, through the inner catheter lumen 10.

[0089] To retract, reposition, or remove the balloon membrane 6, the inner catheter 8 can be pulled proximally to pull the balloon membrane 6 back into the outer catheter 4. The balloon membrane 6 can be deflated or the media pressure 14 reduced and the entire system withdrawn from the target site.

[0090] FIG. 2 shows that the everting balloon system 2 may have a system handle 30. System handle 30 may have a system handle connector 32. System handle 30 can be attached to outer catheter 4 and inner catheter 8 at system handle connector 32, for example. System handle connector 32 may be removably attached to outer catheter 4. For example, the outer and inner catheters 4, 8 and balloon can be removed from the system handle 30 and replaced. System handle 30 may be sterilizable. Prior to catheter and balloon installation or replacement, the system handle 30 may be filled with a medium (eg, liquid or gas) to be delivered by the system handle 30.

[0091] The system handle 30 may have a rigid system handle case 34 and a rigid pump lever 36 rotatably attached to the case of the system handle 30 at a pump lever shaft 38.

[0092] System handle 30 may have an inlet 40. The everting balloon system 2 may have a source of pressure. The pressure source may include a flexible liquid reservoir 42 or a fluid supply container or bladder. The fluid bladder can be filled with hydraulic and/or pneumatic fluid.

[0093] The inlet 40 may be a female luer fitting and connection. Inlet 40 may be in fluid communication with flexible reservoir 42 via inlet reservoir channel 44 . Liquid reservoir 42 may be between rigid pump lever 36 and rigid system handle case 34. Inlet 40 may extend out from the proximal end of system handle case 34. Inlet 40 can be configured to attach to a liquid source (eg, a hose, tube, or auxiliary reservoir configured to deliver liquid through inlet 40 to liquid reservoir 42). Inlet 40 includes a proximal check valve or a valve configured to allow flow into liquid reservoir 42 and prevent backflow (e.g., proximal flow from liquid reservoir 42 and out of inlet 40). It may have a one-way valve.

[0094] Liquid reservoir 40 may be in unidirectional or bidirectional fluid communication with media volume 12 (eg, via a check valve).

[0095] When liquid reservoir 42 contains liquid, when liquid reservoir 42 expands, pump lever 36 rotates away from system handle case 34 as indicated by pump lever rotation arrow 46. obtain. The pump lever 36 can be rotated toward the system handle case 34 to compress the liquid reservoir 42 and, for example, pump liquid from the liquid reservoir 42 into the medium volume 12 of the everting balloon 18 .

[0096] The pump lever 36 is capable of performing a pumping (eg, suction) action to draw liquid from the medium volume 12 of the everting balloon 18. A spring in the lever facilitates the pumping action of the lever, allowing it to open (not shown) with each compression.

[0097] System handle 30 may have a forward slide 48. Advancement slide 48 can be translated proximally and distally relative to system handle case 34, as shown by arrow 50. Advancement slide 48 can be configured to translate inner catheter 16 relative to outer catheter 4. For example, pushing the advancement slide 48 distally forces the inner catheter 8 distally relative to the outer catheter 4, allowing the abduction balloon 18 to evert. Pulling advancement slide 48 proximally pulls inner catheter 8 proximally relative to outer catheter 4, allowing abduction balloon 18 to be retracted. The advancement slide 48 may have gears, ratchets with racks, and rotating advancement screws.

[0098] The advancement button may be an advancement ratchet or roller wheel engaged within or with the inner catheter 8 to allow translation of the inner catheter 16.

[0099] The physician can advance the inner catheter 8 with one hand, abduct the abduction balloon 18, cross the cervical canal with the abduction balloon 18, and access the uterine catheter through the inner catheter lumen 10. .

[0100] Fluid reservoir 42 may be pressurized prior to placing the distal tip of outer catheter 4 in the neck. The fluid reservoir 42 may have a check valve or one-way valve proximal to the handle. The proximal check valve is the connection point through which the physician pressurizes the system. The distal portion of the fluid bladder can be attached to a distal pressure check valve 52. The distal pressure check valve 52 opens when the pressure from the fluid bladder is greater than or equal to the distal check valve's threshold pressure, such as about 1 atmosphere from the liquid reservoir, and then removes liquid and liquid from the liquid reservoir 42. Pressure can be delivered to fill and pressurize the catheter's media volume 12 and everting balloon 18. Distal pressure check valve 52 may be a one-way valve and allows hydraulic or pneumatic fluid or medium to be delivered from fluid reservoir 42 to catheter medium volume 12 and everting balloon 18. The distal pressure check valve 52 can also have pressure values higher or lower than 1 atmosphere, for example from about 0.5 atmospheres to about 2 atmospheres.

[0101] During pressurization of the fluid reservoir 42 (e.g., by pumping with the pump lever 36 or from inlet via the proximal check valve 54), the reservoir limit pressure of the distal pressure check valve 52 A pressure greater than (eg, 1 atmosphere) opens the distal pressure check valve 52 and allows fluid medium to flow from the liquid reservoir 42 into the catheter's medium volume 12 and the everting balloon 18. Pressurization of the catheter's media volume 12 and the everting balloon 18 allows the everting balloon 18 to expand and evert under hydraulic pressure. After the everting balloon 18 is fully everted, excess media may remain in the fluid reservoir 42.

[0102] The distal pressure valve 52 can be connected to a three-way connector 56 (eg, a Y connector or a T connector) with a hemostasis valve 58, such as a Touhy-Borst valve. For this reason, the fluid reservoir 42 is placed within the system so that the user (e.g., a physician) can use it as needed by rotating the pump lever 46 without changing the position of the hand or using the other hand. Additional potential water pressure can be staged or retained.

[0103] Inner catheter 8 can extend through three-way connector 56. Inner catheter 8 can be translated (i.e., advanced and retracted) via three-way connector 56 while maintaining a seal (i.e., without catheter media volume 12 and everting balloon 18 losing pressure). . The inner catheter 8 (if it is a solid rod or mandrel, for example) can withstand up to about 5 atmospheres of water pressure or up to about 10 atmospheres of water pressure during the abduction process, and can withstand up to about 2 pounds or up to about 500 degrees without deformation. It can be configured to withstand pounds of translational (eg, forward, backward, tensile, compressive, or combinations thereof) forces. As an example, during the abduction process, an inner catheter 8 having an inner catheter lumen 10 (e.g. a through lumen) is exposed to media pressure 14, tension as the everting balloon membrane 6 traverses a curved or tortuous anatomy. Instruments, catheters, media, or substances can be passed through the penetrating lumen, withstanding forces, compressive forces, and rotational forces. Actuation of the advance button on the handle moves the inner catheter 8 through the three-way connector 56 and through the outer catheter 4. The everting balloon 18 can then be everted and rolled out of the outer catheter 4 and across the target site (eg, the cervical canal).

[0104] After accessing the target site, the user may, for example, activate pressure release control 60 to release or reduce pressure from media volume 12, thereby deflating or reducing the outer diameter of everting balloon 18, and Alternatively, the abduction balloon 18 and inner catheter 8 can be withdrawn manually by retracting the advancement slide 48 or pulling the system handle 30 proximally, and thus the remainder of the system.

[0105] After the abduction balloon 18 has traversed the biological lumen to be traversed (e.g., the cervical canal or urethra), the abduction balloon system 2 increases the pressure within the abduction balloon 18, e.g. The diameter of 18 can be increased or a constant diameter of everting balloon 18 can be maintained (eg, in the case of a fiber-reinforced everting balloon 18 or a balloon membrane 6 constructed of a less expansive material). Pump lever 36 may be compressed to increase the pressure generated within fluid reservoir 42 and exiting distal pressure check valve 52. Proximal check valve 54 can prevent or minimize fluid medium (eg, pneumatic or hydraulic) from leaking or flowing proximally out of inlet 40 .

[0106] A user can rotate pump lever 36 to increase the pressure within fluid reservoir 42, media volume 12, and everting balloon 18, for example. The outer diameter of the balloon can then be increased to further push open the diameter of the biological lumen. For example, everting balloon 18 can dilate the neck and cervical canal. Then, at the same time as placing the abduction balloon system 2 into the cervical canal, or after withdrawing the abduction catheter system 2 from the cervical canal, endoscopes, instruments, Heger dilators, and other devices that further increase the cervical diameter are used. A tool, such as a device, or a combination thereof, can be inserted into the dilated cervical canal.

[0107] Pump lever 36 may provide tactile feedback to the user indicating the pressure of everting balloon 18. The everting balloon system 2 may have a fluid reservoir 42 and/or a pressure gauge indicative of the pressure within the media volume 12 of the catheter and the everting balloon 18, etc.

[0108] The system handle 30 may have a pressure release control 60, such as a toggle lever or knob. Pressure release control 60 can release fluid from fluid reservoir 42 and/or catheter media volume 12 and everting balloon 18.

[0109] Pressure release control 60 can be connected to hemostasis valve 58. The hemostasis valve 58 may have a seal or sealing gasket. Pressure release control 60 may be configured to open and close the sealing gasket by rotating the sealing cap or to open a connection to a separate drainage tube (not shown) in fluid communication with media volume 12. can.

[0110] The pressure release control 60 may be located on the handle 30 on which the user's thumb rests, distal to the advancement slide 48 and in line with the movement of the advancement slide 48. Pressure release control 60 can be operated with the same hand that the user operates advancement slide 48 and pump lever 36.

[0111] Using the pressure release control and handle, the user can advance and deliver the IUD with one hand.

[0112] A user can perform the following operations of the abduction balloon system 2 with one hand (eg, without the use of the other hand or another operator) without changing the position of the hand.

a. Pressurize the liquid reservoir 42.

b. Position or place the distal end of the abduction balloon system 2 on the patient's neck.

c. Control the position of the everting balloon system 2 during use.

d. Advance inner catheter 8 and balloon membrane 6.

e. Expanding the diameter of everting balloon 18 by pumping more water pressure from fluid reservoir 42.

f. Retract inner catheter 8 and balloon membrane 6.

g. Activating the pressure relief control 60 to remove or release pressure from the abduction catheter system.

[0113] Structurally, the buttons or actuators to enable these features are on the handle, allowing the operator to access these features without changing hand position or requiring use of the other hand. can be operated. For example, advancement and retraction of the inner catheter 8 can be accomplished by a sliding mechanism or gear located on the upper side of the handle, approximately 4 inches from the proximal end of the handle or handle grip. The lever and ratchet mechanism can be located on the underside of the handle at a distance of about 2 inches to about 4 inches from the proximal end of the handle grip. The additional actuator may be located on the side of the handle grip, about 3 inches to about 4 inches from the proximal end of the handle grip, or on the top or bottom of the handle grip, about 3 inches to about 4 inches from the proximal end. Can be placed at 4 inch position. The location of the buttons and actuators is easily known to the operator without visual confirmation, allowing the user to maintain eye contact with the patient or continue looking at a visualization source such as an endoscope monitor or ultrasound image. .

[0114] During use of the abduction balloon system 2, the user uses the other hand to move the ultrasound probe, support beam (e.g., if access to the neck is difficult due to anatomical reasons, or stabilization of the patient or other equipment, or a combination thereof.

[0115] FIG. 3A shows that inner catheter 8 can be attached to dilatation balloon 62 or inner catheter balloon. Dilatation balloon 62 may be radially inward of everting balloon 18. The distal and proximal ends of dilatation balloon 62 can be attached and sealed to inner catheter 8. Inner catheter 8 may have a longitudinal expansion balloon port 64 within expansion balloon 62 . The dilation balloon port 64 may be in fluid communication with a source of fluid pressure at the proximal end of the everting balloon system 2 within or attached to the system handle 30, for example. Dilation balloon 62 can be inflated and deflated via dilation balloon port 64.

[0116] Dilatation balloon 62 may have greater, the same, or less compliance than everting balloon 18. The walls of everting balloon 18 may be thicker, thinner, or the same thickness as the walls of dilatation balloon 62. The everting balloon 18 is made of copolymers such as silicone, urethane, rubber, latex, polyethylene, polyolefin, irradiated polyolefin in combination with ethylene vinyl acetate, polyether block amide (PEBA, also known as Pebax), etc. , fiber-reinforced polymers, PET, nylon, or combinations thereof. The dilatation catheter may be made from any of the materials listed for everting balloon 18.

[0117] The everting and/or dilating balloon membrane 6 may have a thickness of about 0.001 to about 0.004 inches.

[0118] The everting and/or dilatation balloons 18, 62 may be internally coated with a lubricious material such as silicone oil, mineral oil, other lubricants, or combinations thereof. A lubricious coating can reduce friction within the balloon during eversion.

[0119] The exterior of the everting and/or dilation balloon 18, 62 may be smooth, for example the balloon may be made by tube extrusion. Balloons can be blow molded. For example, the outer surface of the balloon may have ridges or other surface protrusions, eg, to increase friction or retention within a target body cavity (eg, a cervical channel or urethra). The outer diameter of the balloon can vary dimensionally. For example, the most distal portion of everting balloon 18 can be manufactured with a larger outer diameter to accommodate larger vessel sizes or expansion that may extend into the bladder.

[0120] In use, the everting balloon 18 can pull the inner catheter 8 into the cervical canal. When eversion balloon 18 is deployed into the cervical canal, dilation balloon 62 can be positioned within the cervical canal.

[0121] FIG. 3B shows that dilatation balloon 62 may be inflated by delivering pressurized fluid through dilatation balloon inflation port 64. Dilatation balloon 62 can be expanded within everting balloon 18. Dilatation balloon 62 may be inflated to dilation balloon diameter 66.

[0122] Dilatation balloon 62 may have a predetermined or shaped size and shape. For example, dilatation balloon 62 may have dilatation balloon diameter 66. For example, the maximum dilatation balloon diameter 66 or the maximum abduction balloon diameter can be from about 2 mm to about 1230 mm, and in some applications (e.g. for cervical use) the diameter can be up to about 20 mm (e.g. (for example, when used in the urethra) a narrower range of about 2 mm to about 10 mm, a narrower range of about 6 mm to about 12 mm (for example, when used in the urethra) an even narrower range of about 2 mm to about 7 mm, (for example, (When used in the male urethra) It can be in a narrower range of about 3 mm to about 4 mm. Expansion balloon 62 may be inflated to a preset outer diameter. (The dilatation balloon outer diameter 66 can be less than or equal to the dilation diameter required for a body cavity such as the neck.) The abduction balloon 18 can have a maximum abduction balloon diameter less than or equal to the maximum dilatation balloon diameter 66. .

[0123] Dilatation balloon 62 can be inflated to the same pressure as everting balloon 18 or a higher pressure than everting balloon 18. For example, dilatation balloon 62 may have a dilatation balloon pressure of about 4 atmospheres to about 12 atmospheres, and up to 20 atmospheres, eg, to interrupt a pathological stenosis or condition within a body cavity.

[0124] When dilatation balloon 62 is inflated, dilatation balloon 62 expands to dilation balloon diameter 66, allowing everting balloon 18 to expand. The inflation medium within everting balloon 18 may remain within the balloon or be withdrawn before, during, and/or after inflation of dilatation balloon 62. In the abducted state, there is a frictional force of the abductor balloon membrane 6 against the body cavity, so that, for example, the abductor balloon membrane 6 functions to maintain the position of the dilatation balloon 62 during the expansion process, and the body cavity is This prevents the system from moving forward or backward unintentionally.

[0125] If the abduction balloon diameter expands beyond the strain limit of the abduction balloon 18, the dilatation balloon 62 may inflate and rupture or break the abduction balloon 18. The inflation medium within the everting balloon 18 may remain within the balloon or be withdrawn before, during, and/or after inflation of the dilatation balloon 62, e.g., if the everting balloon 18 ruptures open. There is a possibility that it will come out of Balloon 18.

[0126] The everting balloon 18 can break or rupture along the intended line upon inflation of the dilation catheter. For example, the abduction balloon 18 can be ruptured by a mechanical instrument on or within the outer catheter 4, on the proximal portion of the inner catheter 8, which becomes active when the dilatation balloon 62 is fully everted and inflated. sharp implement and/or the inner catheter 8 is further advanced to release the attachment or bond between the everting balloon 18 and the inner catheter 8 at the distal end of the inner catheter 8. Rupture or breaking of the everting balloon 18 involves mechanical means that cause the balloon membrane 6 to tear when a certain strain limit is reached, such as in a helical line, a transverse line, a longitudinal line, or a combination thereof. This can be done by weakening everting balloon 18 by providing a score or seam. The everting balloon membrane 24 can be fabricated by tautening or expanding the membrane along the longitudinal axis of the balloon during the balloon formation process to increase the longitudinal axis orientation of the molecular structure. This may facilitate longitudinal tearing if the everting balloon membrane 24 rips or ruptures. Radial tearing of the everting balloon 18 is facilitated by manufacturing the balloon membrane 6 by increasing the radial orientation of the molecular structure by radially expanding or taut the balloon membrane 6 during the balloon formation process. can.

[0127] The system handle 30 can hold an inflation medium that is delivered to and from everting balloon 18 and dilatation balloon 62. The inflation medium may be contained within a liquid reservoir 42 (eg, a fluid bladder or syringe piston). The inflation medium can be delivered to the dilatation balloon after inflation and eversion of everting balloon 18, for example via a valve. System handle 30 may have a gear or ratchet configured to advance inner catheter 8. Outer catheter 4 may extend approximately 25 cm distal to system handle 30. The system handle 30 and actuator can be controlled with one hand to inflate eversion balloon 18 and dilatation balloon 62.

[0128] Dilatation balloon 62 can be positioned within the neck to dilate the neck.

[0129] FIGS. 4A to 4C show that the inner catheter 8 can be in a fully retracted position inside the outer catheter 4.

[0130] FIG. 4A shows that the system handle 30 can include a pump lever 36, such as a ratchet handle 68, a syringe connector 70, and a plunger drive plate 72. Ratchet handle 68 may include a knob, trigger, lever, pump mechanism, or a combination thereof. The fluid reservoir can be a syringe 74. The volume of the syringe 74 can be from about 5 cc to about 20 cc, for example about 5 cc or about 20 cc. The open distal port of the syringe can be attached to and in fluid communication with the syringe connector 70. Syringe connector 70 may have a distal pressure valve 52. Syringe connector 70 can be rotatably attached to system handle case 34. Syringe 74 may have a plunger 76 that is longitudinally translatable relative to the remainder of syringe 74 . Syringe 74 can be filled with any medium disclosed herein, such as saline, water, gas, or combinations thereof. The liquid reservoir 42 has two separate syringes 74, each of which can be attached to and in fluid communication with the same or different syringe connectors 70. For example, a first syringe can be in fluid communication with everting balloon 18 and a second syringe can be in fluid communication with dilation balloon 62.

[0131] Syringe 74 can be fixed to syringe connector 70.

[0132] Outer catheter 4 may have an outer catheter distal tip 78. The outer catheter distal tip 78 can be an atraumatic tip, such as an acorn-shaped tip or a stop. Outer catheter distal tip 78 can be configured to prevent insertion of outer catheter 4 too far into a target biological lumen (eg, the cervix).

[0133] Outer catheter distal tip 78 may have an outer catheter distal port 80. The outer catheter distal port 80 may be large enough to pass the inner catheter 8 and balloon.

[0134] FIG. 4B shows that syringe connector 70 and syringe 74 may be rotated as indicated by the arrows such that the longitudinal axis of syringe 74 is parallel or co-linear with the longitudinal axis of outer catheter 4. shows. Syringe connector 70 may be angularly fixed relative to the remainder of system handle 30. Plunger drive plate 72 can be rotated and/or translated into contact or near contact with the proximal end of syringe plunger 76.

[0135] FIG. 4C shows that the system handle 30 may have a plunger driver 82. Plunger driver 82 may include a linear rack or plunger drive screw 84, a plunger drive collar 86, and plunger drive plate 72. Ratchet handle 68 can be pulled to rotate plunger drive screw 84 or linear rack as indicated by arrow 87. Plunger drive screw 84 or linear rack may be configured to translate plunger drive collar 86. For example, plunger drive collar 86 may have internal threads that engage external threads of plunger drive screw 84. Plunger drive collar 86 may be translatably secured to plunger drive plate 72. When ratchet handle 68 is pulled, plunger drive collar 86 and plunger drive plate 72 can be translated distally relative to the remainder of syringe 74. Plunger drive plate 72 can contact plunger 76 and force it distally, as shown by the arrow.

[0136] Ratchet handle 68 may have a ratchet to prevent reversal of direction of the plunger driver, for example to prevent proximal translation of plunger 76. The release lever may be rotated or deployed to release the ratchet mechanism during assembly disengagement, system retraction, or redeployment. The ratchet handle 68 may, for example, have no ratchet or two-way ratchet to control the direction of the plunger driver 82, and may, for example, allow proximal and distal translation of the plunger 76. Plunger drive plate 72 may be fixed to plunger 76, or may contact but not be fixed to plunger 76.

[0137] Pulling the ratchet handle 68 allows the syringe plunger 94 to be pushed. Pressing the syringe plunger 94 forces inflation medium from the syringe 74 into the medium volume 12 of the dilation and/or everting catheter 18, which can, for example, pressurize each balloon.

[0138] FIGS. 5A-5F show that the system handle 30 can have a water stop and check valve 88 extending from the three-way connector 56. A stop valve and check valve 88 may be in fluid communication with the media volume 12. The stop valve and check valve 88 may be located on the outside (as shown) or inside the system handle case 34. The stop valve and check valve 88 may be accessed to add media within the media volume 12, remove media, or check the pressure of the media.

[0139] System handle 30 may have one or more syringe detents 90. A syringe detent 90 may be removably attached to a portion of the syringe 74 to prevent or minimize longitudinal translation of the syringe 74 relative to the system handle case 34. Syringe detent 90 may be configured such that syringe 74 slides in and out of the detent perpendicular to the longitudinal axis of syringe 74.

[0140] System [[Case]] The handle case 34 may have a deflection plate 92. The outer and/or inner catheters 4, 8 can press against the deflection plate 92. The deflection plate 92 can change or deflect the path of the outer and inner catheters 4, 8 in the direction of the longitudinal axis of the target site. Deflection plate 92 may have molded or formed grooves, pins, plates, panels, or combinations thereof. The outer catheter 4 can be manufactured with a preset curvature to accommodate the curved path within the system handle case 34.

[0141] System handle case 34 may have a handle grip 96. Inner catheter 8 may have a linear inner catheter gripping section 98. Inner catheter gripping section 98 may be the length of non-eververted inner catheter 8 within handle gripping section 96 . The inner catheter gripping section 98 can be about 12 cm of the inner catheter 8 in a non-eververted state, for example, about 6 cm (eg, about 50% of the inner catheter gripping section 98) of the everting balloon membrane 24. It can correspond to an abduction length of 98 mm. Alternatively, the inner catheter 8 may wrap around a wheel, have a telescoping section, or have sections that fold and open to accommodate the length of the inner catheter 8 in the non- everted state of the system handle case 34. The amount of distance required within can be reduced.

[0142] System handle 30 may have a reservoir intercatheter channel 100 in fluid communication with the distal end of syringe 74 and the proximal end of inner catheter 8, for example. Reservoir intercatheter channel 100 can be a tube from syringe connector 70 to inner catheter 8.

[0143] System handle 30 may have an access channel 102 extending from the outer surface of system handle connector 32 to the outer surface of system handle case 34. Access channel 102 may terminate proximally at proximal access port 104.

[0144] Inner catheter 8 may extend through access channel 102. Inserting one or more tools or fluids into or adjacent to inner catheter 8 through proximal access port 104 and access channel 102 and/or to a location adjacent to inner catheter 8 can be inhaled.

[0145] System handle 30 may have one or more drive gears 106. Drive gear 106 may be located on one or both sides of access channel 102. Drive gear 106 may penetrate or collide with access channel 102. Drive gear 106 may be rotatably attached to system handle case 34 via drive gear shaft 108. Drive gear 106 may have a gear portion and a drive gear groove 124. Inner catheter 8 may extend through drive gear channel 124. The drive gear 106 can frictionally push and pull the inner catheter 8. One or more of the drive gears 106 may extend to the outside of the system handle case 34 and be exposed. For example, the exposed drive gear 106 can be rotated by pressing with the user's palm or fingers (eg, thumb). Exposed drive gear 106 may be matingly engaged with one or more unexposed drive gears 106. Rotating a first of the drive gears 106 can rotate other drive gears 106 meshingly engaged with the first drive gear 106.

[0146] The system handle case 34 may have a system handle case first side part 110 and a system handle case second side part 112. System handle 30 may be created by attaching system handle case first side 110 to system handle case second side 112. Each drive gear shaft 108 may be rotatably attached to a system handle case first side 110 and a system handle case second side 112.

[0147] The shaft of the pump lever may be the ratchet handle shaft 114. Ratchet handle 68 may rotate about ratchet handle axis 114.

[0148] System handle 30 may have plunger drive rack 116. Plunger drive rack 116 may be attached to plunger drive plate 72. Plunger drive plate 72 may extend vertically from the proximal end of plunger drive rack 116. The side of plunger drive rack 116 facing plunger drive plate 72 may have drive teeth 118 in one or two directions.

[0149] The system handle 30 may have a ratchet handle spring 120 compressed between the system handle case 34 and/or the ratchet handle 68 and/or the ratchet arm 122. For example, ratchet handle spring 122 can reset ratchet handle 68 by rotating ratchet handle 68 forward after ratchet handle 68 is pulled.

[0150] The system handle 30 may have a ratchet arm 122 or actuation pawl. Ratchet arm 122 can be mechanically attached to ratchet handle 68, such as to handle spring 120. The ratchet arm 122 can provide track limiting motion of the ratchet arm 122 relative to longitudinal translation relative to the syringe 74. The proximal end of ratchet arm 122 may be curved into a U-shape. The distal end of ratchet arm 122 may press against ratchet teeth. Ratchet arm 122 may be configured to pull plunger drive rack 116 distally when ratchet handle 68 is pulled. Ratchet arm 122 is configured to move proximally relative to plunger drive rack 116 when ratchet handle 68 is returned to the reset position.

[0151] The system handle 30 has a spring-loaded locking pawl (not shown) between the system handle case 34 and the plunger drive rack 116, for example, to prevent distal translation of the plunger drive rack 116. and prevent proximal translation of the plunger drive rack 116 unless the locking pawl is manually released from the plunger drive rack 116 by the release lever 126.

[0152] As shown in FIG. 5B, outer catheter 4 may have an outer catheter length 128. The outer catheter length 128 can be from about 4 cm to about 35 cm, or more narrowly from about 10 cm to about 24 cm, such as about 17 cm.

[0153] FIGS. 6A-6D show that system handle 30 may have an inner catheter drive tray 130 mounted translatably relative to system handle case 34. FIG. A proximal length of inner catheter 8 may extend proximally from system handle case 34. The proximal length of inner catheter 8 may be within, on, or adjacent to inner catheter drive tray 130.

[0154] The syringe 74 may have a syringe loading connector 132, such as a luer connector, at the distal or proximal end of the syringe 74 (eg, the end remote from the system handle case 34). A delivery tube 133 or delivery device can be attached to the syringe loading connector 132 to deliver pressurized medium into the syringe 74 through the syringe loading connector 132.

[0155] As shown in FIG. 6C, the delivery tube 133 or delivery device can be removed from the syringe loading connector 132 before everting balloon 18 is deployed. Delivery tube 133 can be coiled within handle grip 96 to connect syringe 74 and its pressurized medium to three-way connector 56 and hemostasis valve 58 or inlet 40 for dilatation balloon 62 .

[0156] The proximal end of inner catheter 8 can be attached to proximal access port 104. The proximal end of inner catheter drive tray 130 may have one or more access port detents 134. An access port detent 134 can be attached to the proximal access port 104. Access port detent 134 may be removably attached to a portion of proximal access port 104 to prevent or minimize longitudinal translation of proximal access port 104 relative to inner catheter drive tray 130. Access port detent 134 may be configured such that proximal access port 104 slides in and out of access port detent 134 perpendicular to the longitudinal axis of inner catheter drive tray 130.

[0157] Inner catheter drive tray 130 can be translated along the longitudinal axis of inner catheter drive tray 130 to translate inner catheter 8 (e.g., advance inner catheter 8 into a target site). . The inner catheter can deliver an IUD, instrument, device, endoscope, or dilatation balloon.

[0158] As disclosed herein, system handle case 34 may have a fluid connection between syringe 74 and outer catheter 4.

[0159] As shown in FIG. 6A, the ratchet arm 122 can extend away from the drive rack 116 to form a release lever 126. One or more other release levers 126 may extend from other locations on the system handle 30, as shown in FIGS. 6B and 6D. Rotating release lever 126 may disengage ratchet arm 122 from drive rack 116.

[0160] Ratchet handle 68 may have a safety lock hole 136. A safety lock having a cable or bar removably extends through the safety lock hole 136 to create an interference fit against the system handle case 34, for example, to prevent rotation of the ratchet handle 68, and to prevent rotation of the ratchet handle 68, e.g. from the syringe 74. Failure or premature delivery of the medium can be prevented.

[0161] The ratchet handle 68 may be laterally divided into a catheter sub-handle 138 and a media sub-handle 140. Catheter subhandle 138 may be configured to control advancement of inner catheter drive tray 130. Media subhandle 140 may be configured to control the pressure of media delivery from syringe 74. Catheter subhandle 138 can be attached to the inner catheter drive rack. The media sub-handle can be attached to the plunger drive rack.

[0162] Ratchet handle 68 controls syringe 74 to apply media pressure to everting balloon 18 and dilatation balloon 62, and can also independently control translation of inner catheter 8.

[0163] Figures 7A and 7B show that the inlet 40 may have a female Luer connector. System handle connector 32 may have a female Luer connector. The outer catheter distal tip 78 can have a soft rubber or polymeric acorn-shaped tip, for example, to stabilize the abduction system 2 at the opening of a body cavity or to prevent unintentional advancement of the outer catheter 4 within the body cavity. We can help you do that.

[0164] Reservoir intercatheter channel 100 may extend from three-way connector 56 out of system handle case 34. The proximal end of the reservoir intercatheter channel 100 can be attached to a female Luer connector and/or a distal pressure valve 52. A distal pressure valve 52 and/or a female Luer connector can be connected to a liquid reservoir 42 (not shown).

[0165] FIG. 8A shows that the three-way connector 56 can have a hemostasis valve 58. Three-way connector 56 may include or be a Touhy-BorstY connector. Inner catheter 8 may extend through three-way connector 56.

[0166] The three-way connector 56 may have a distal gasket 142 between the reservoir intercatheter channel 100 and the system handle connector 32. Distal gasket 142 may have a cylindrical distal gasket port 144 extending through a radially central portion of distal gasket 142. Distal gasket port 144 may have a distal gasket port diameter.

[0167] Three-way connector 56 may have a proximal gasket 146 proximal to distal gasket 142. Proximal gasket 146 may be positioned between reservoir intercatheter channel 100 and the proximal outlet through which inner catheter 8 exits proximally from three-way connector 56. Proximal gasket 146 may have greater, the same, or less compliance than distal gasket 142. Proximal gasket 146 may have a cylindrical proximal gasket port 148 extending through a radially central portion of proximal gasket 146. Proximal gasket 146 may have a proximal gasket port diameter.

[0168] Inner catheter 8 may have an inner catheter minor diameter length 150 and an inner catheter major diameter length 152 proximal to inner catheter minor diameter length 150. The inner catheter 8 may have an inner catheter proximal inflation hole 154 at the distal end of the inner catheter large diameter length 152. Inner catheter proximal inflation hole 154 may be in fluid communication with the open distal end of inner catheter lumen 10 and/or dilatation balloon port 64.

[0169] Positive media pressure 14 or flow can be delivered through the reservoir intercatheter channel 100 to the three-way connector 56, as indicated by the arrows. Inner catheter large diameter length 152 can occlude, occlude, and/or seal proximal gasket port 148. Positive media pressure 14 or flow flows between the outer catheter 4 and the inner catheter through the gap between the outer diameter of the inner catheter 8 and the inner diameter of the distal gasket port 144 (e.g., along the inner catheter small diameter length 150). 8 and into a medium volume 12 between the two, for example into an everting balloon 18.

[0170] FIG. 8B shows that the inner catheter 8 may be translated distally, as indicated by the arrow, at least until the inner catheter large diameter length 152 has moved into the distal gasket port 144. Inner catheter large diameter length 152 may slide through proximal gasket port 148. Inner catheter large diameter length 152 can occlude, occlude, and/or seal distal gasket port 144 and/or to distal gasket 142. Flow of medium 155 from reservoir intercatheter channel 100 may flow into inner catheter proximal inflation hole 154. Media 155 can flow downstream of inner catheter lumen 10, eg, to dilatation balloon 62.

[0171] Exemplary procedures for delivering an IUD (not shown) or dilating a body cavity such as the cervical canal may include the following.

1. Syringe 74 can be loaded into system handle 30. The system handle 30 can be a separate reusable item, and the everting catheter and syringe filled with medium 155 can be attached to the rest of the system before use. Alternatively, the system handle 30 may be supplied to the end user pre-assembled with the rest of the system, pre-filled, or a combination thereof.

2. The distal end of the abduction catheter system 2 can be placed in the cervicovaginal region.

3. Ratchet handle 68 can be pressed. The first one or two clicks of the ratchet (ie, when the locking pawl passes the ratchet teeth) can push the syringe plunger 94 and pressurize the everting balloon 18. The everting balloon 18 can be pressurized to 4 to 6 atmospheres.

4. The ratchet handle 68 can be pushed further (or released and reset to rotation and then pushed further). Such subsequent clicks of ratchet handle 68 may indicate advancement of inner catheter 8. This may be accomplished by a ratchet mechanism rotating a gear on the inner catheter 8 and/or by translating a linear rack to advance the inner catheter 8.

5. The ratchet handle can be pushed further (or released and reset to rotation, then pushed further). Inner catheter 8 can continue to be advanced until the abduction balloon is fully deployed and everted. An expansion balloon 62 can be positioned at the distal end of inner catheter 8.

6. Ratchet handle 68 can be pushed further. Such subsequent clicks of the ratchet can either decompress the everting balloon 18 or deliver the IUD (not shown).

7. Ratchet handle 68 can be pushed further. Such subsequent clicks of the ratchet can change the pressurized outlet of the syringe 74 from the everting balloon 18 to the dilatation balloon 62. Alternatively, this action can deliver an IUD (not shown). This can be achieved, for example, by:

a. rotate the valve by a ratchet mechanism, b. rotate the valve manually, and/or c. Advance the inner catheter 8 to a position where it is exposed.

8. Ratchet handle 68 can be pushed further. Such subsequent clicks of the ratchet may indicate inflation of dilation balloon 62.

9. Dilation balloon 62 may rupture the overlying eversion balloon 18.

10. The amount of force in biological lumen expansion can be adjusted by a pressure relief valve or by the volume of medium 155 that can be placed within dilation balloon 62. Expansion pressure can be monitored by a pressure gauge within or attached to the system handle case 34. The expansion balloon 62 can expand the neck to about 6 atm to about 20 atm. The dilatation balloon 62 can initially deliver about 10 to about 12 atmospheres and reduce the pressure once the neck has expanded and the dilation process is complete. The system is also capable of delivering a known volume of medium 155 into dilatation balloon 62 independently of quantifying or measuring medium pressure 14.

11. The expansion process may be observed by ultrasound or radiographic imaging.

12. A pressure release button on the system handle 30 can be activated to remove or reduce the expansion pressure of the media volume 12 within the inner catheter lumen 10.

13. Retract syringe plunger 94 to draw a vacuum on inner catheter lumen 10 and dilatation balloon 62, loosening dilation balloon 62 from, e.g., the neck, and/or deflating dilatation balloon 62, e.g. Removal of the everting balloon system 2 can be facilitated.

14. If additional dilation force is desired, for example in the neck, the abduction balloon system 2 can be pressurized again. For example, if additional stenosis is visualized in the neck, dilatation balloon 62 can be repositioned and inflated in the area of additional stenosis.

[0172] Abduction catheter systems access body cavities (e.g., the uterine cavity or fallopian tubes) and provide tools (e.g., IUDs and instruments), reproductive (e.g., embryos, products of in vitro fertilization (IVF) or insemination, e.g., hormones) A medium 155 or substance, contrast agent, dye, therapeutic agent, sclerosing agent to treat the endometrium, insufflation media, or combinations thereof can be delivered or introduced into the body cavity. For example, reproductive media can be delivered using an implanted catheter inserted into the uterine cavity through inner catheter lumen 10.

[0173] FIG. 9 shows that a graft catheter 156 or insemination catheter can have a graft connector 158, such as a female Luer connector, a strain relief length 160, and a graft tube 162. Implant tube 162 can hold reproductive media. Graft tube 162 may have a proximal length having a proximal major diameter that is greater than the distal major diameter of the distal length of graft tube 162. A delivery force, such as, for example, positive fluid pressure, can be applied through implant connector 158 and strain relief length 160 to force the contents of implant tube 162 into the target site.

[0174] Implant catheter 156 may be attached to or inserted through inlet 40. Transfer tube 162 can hold an embryo for, for example, in vitro fertilization or IVF. Embryo transfer catheter 156 can deliver embryos through the system and into the uterine cavity. Transfer catheter 156 can hold and deliver sperm through the system to the uterine cavity for intrauterine insemination procedures. The implantation catheter 156 holds and delivers other materials, drug deposition, therapeutic agents, instruments, endoscopes, cytology brushes, other catheters, or combinations thereof through the system into the uterine cavity. be able to. The implantation catheter 156 can be connected to a vacuum source for aspirating material from the uterine cavity or other body cavities and lumens.

[0175] Prior to everting the everting balloon 18 within a vessel or body lumen, the inner catheter lumen 10 may be loaded with the implantation catheter 156 and/or material. For example, to deliver reproductive material to the uterine cavity, the implantation tube 162 of the implantation catheter 156 can be filled with washed and prepared spermatozoa, and the implantation catheter 156 can be placed in the inner catheter lumen 10.

[0176] A guidewire can be inserted into the implantation catheter 156 and/or the remainder of the system, eg, to guide the tube or system to the target site 164. A guidewire may be used for recanalization.

[0177] With the inner catheter 8 extended, the everting balloon 18 can evert and expand through the cervix and into the uterine cavity. Simultaneously or thereafter, implantation catheter 156 may be advanced through inner catheter lumen 10 and into the uterine cavity. Once fully abducted, or once the transfer catheter 156 has been extended or exposed beyond the everting balloon membrane 24 from the inner catheter 8, the reproductive material 166 within the transfer catheter 156 can be removed using the syringe 74, squeeze bulb, or piston. , or other pressure systems. At the same time, a second delivery catheter, such as a second insemination catheter, an IVF catheter, or a drug delivery catheter, can be inserted into the inlet 40 or the second inlet. A second delivery catheter may be deployed to target site 164 simultaneously with or after implantation catheter 156.

[0178] System handle 30 may have a lead-in area. The introduction area has no steps, edges, irregularities, or restrictions that could obstruct or contact the distal opening of the implantation catheter 156 during passage, e.g., when delivering insemination substances. , the implant catheter 156 can be easily loaded into the system handle 30. An insemination syringe 74 or pump is attached to the proximal implant connector to deliver pressure to the implant tube 162, e.g., after the distal port of the implant catheter 156 is positioned at the target site 164 (e.g., once the abduction balloon 18 is completely (after being expanded), reproductive material 166 can be released. Actuation of the insemination syringe or pump on the preloaded implantation catheter 156 can be performed using the same hand that holds and manipulates the components of the abduction catheter system.

[0179] Additionally, the transfer catheter 156 can be configured to be introduced into the proximal connector of the handle of the everting catheter system after the system is fully deployed.

[0180] A user may do any or all of the following while using the everting balloon system 2, for example with one hand.

a. Pressurize the abduction catheter system b. Position the abduction balloon system 2 on the patient's neck c. Maintain the position of the abduction balloon system 2 during the procedure d. Inner catheter 8 and abduction balloon 18 e. After extending beyond the everting balloon membrane 24 or the inner catheter 8, present the implantation catheter 156 for placement into a body cavity, such as the uterine cavity.f. The inner catheter 8 and the everting balloon retracting 18 and/or g. activating (eg, toggling) a pressure release lever to remove or release water or air pressure from media volume 12;

[0181] FIGS. 10A-10C show that the distal end of the everting balloon can have a balloon check valve 168. The length of everting balloon 18 distal to the distal end of inner catheter 8 can be radially deflated to form a narrow orifice that can become a balloon check valve 168. Balloon check valve 168 can be an openable barrier that can prevent or interrupt fluid communication between inner catheter lumen 10 and target site 164.

[0182] Balloon membrane 6 may have overlapping walls of about 1 mm to about 3 mm at balloon check valve 168 that closes inner catheter lumen 10. The strength or closing pressure of balloon check valve 168 can be adjusted during use. For example, by controlling the amount of excursion available to inner catheter 8 and everting balloon membrane 24, the overlap distance of balloon membrane 6 can be increased or decreased.

[0183] FIG. 10B shows that the distal end of the implantation catheter 156 may be advanced through the inner catheter lumen 10 and through the balloon check valve 168 to the target site 164, as indicated by arrow 170. Show that. When the implantation catheter 156 is moved through the balloon check valve 168, it can penetrate or push the balloon check valve 168 open. When the distal end of the transfer catheter 156 is distal to the balloon check valve 168 and at the target site 164, the reproductive material 166 loaded within the transfer catheter 156 is routed through the distal port of the transfer catheter 156 into the uterine cavity, etc. can be delivered (172) into the target site 164.

[0184] FIG. 10C shows that after the reproductive material is placed at the target site 164, the implantation catheter 156 may be withdrawn through the balloon check valve 168 and the inner catheter lumen 10. When the implantation catheter 156 is retracted through the balloon check valve 168, the balloon check valve 168 can be closed. As the implantation catheter is advanced (170) through the balloon check valve 168, rests within the balloon check valve 168, and retracted through the balloon check valve 168, the balloon check valve 168 A seal between inner catheter lumen 10 and target site 164 can be maintained.

[0185] The reproductive material 166 is isolated from vacuum effects or withdrawal of the reproductive material 166 from the target site 164 as a result of the vacuum force resulting from withdrawing the implantation catheter 156 within the system after placement of the reproductive material 166 is completed. be able to. Balloon check valve 168 can remove or eliminate the vacuum effect for embryo transfer.

[0186] Balloon check valve 166 may be a tactile indicator to the physician when passing implantation catheter 156 through everting balloon system 2. In an implantation procedure, the amount of insertion of implantation catheter 156 through the distal end of the abduction system may vary from patient to patient, depending on, for example, physician preference or patient anatomy. As the distal end of the implantation catheter 156 passes through the balloon check valve 168, the resistance created by the balloon check valve 168 is felt by the physician at the proximal end of the implantation catheter 156. Depending on the length of the balloon selected to act as balloon check valve 168, the degree or amount of resistance can be adjusted. In some treatment settings, the ability to determine the amount of insertion of the implantation catheter 156 into the everting balloon 18 or the physical depth indications or markings on the proximal end of the implantation catheter 156 may be limited. This poor interrogation ability may be due to poor lighting within the treatment room to improve monitor imaging and visualization. Additionally, the physical presence of the physician, embryologist, or other persons or equipment within the procedure room may reduce the ability to easily see the amount inserted into the abduction catheter. The tactile sensation of resistance of balloon check valve 168 can provide a clear indicator that implantation catheter 156 is at the distal end of everting balloon 18.

[0187] The everting balloon system 2 can be used to access and seal the uterine cavity, for example, for placement of reproductive material 172 for long-term intrauterine insemination.

[0188] FIGS. 11A-11C illustrate that the everting balloon membrane 24 may create a seal within the cervical canal (eg, against the cervical wall 174) as the everting balloon 18 traverses the cervical canal. FIG. 11A shows that as the balloon is pressurized and the inner catheter 8 is advanced distally, the everting balloon membrane 24 can spread and advance along the cervical canal wall, as indicated by the arrows. The outer catheter 4 can also be sealed against the cervical wall 174. For example, the outer diameter of the outer catheter 4 can be equal to the outer diameter of the everting balloon.

[0189] FIG. 11B shows that the transfer catheter 156 may be advanced distally within everting balloon 18 and inner catheter lumen 10. Transfer catheter 156 can place reproductive material 166 (eg, sperm) within uterine cavity 176.

[0190] FIG. 11C shows the implant catheter 156 and/or inner catheter 8 being retracted (eg, about 3 mm to about 10 mm) or inverted, as indicated by the arrows, and the uterus removed as indicated by the arrows. It is shown that the distal end of inner catheter lumen 10 can be closed to lumen 176. For example, the distal opening of balloon 178 may close due to pressure within everting balloon 18 causing everting balloon 18 to form balloon check valve 168 . Balloon check valve 168 can seal the cervical and uterine cavity 176 from inner catheter lumen 10. The reproductive material 166 can remain within the uterine cavity 176 without being expelled through the cervix.

[0191] 12A-12E illustrate an abduction catheter for performing an IUD placement procedure. FIG. 12A shows an abduction catheter with an IUD housed within the abduction catheter system 2 in the inversion membrane position. The everting membrane and IUD (not visible in this view) are housed within outer catheter 4 with an acorn-shaped tip 242 at its distal end. Acorn-shaped tip 242 may have an opening (not visible) at the distal end. At the proximal end of the outer catheter 4 there is a T-fitting or Y-fitting 244 that includes an X-ring gasket (not visible). Extension tube and bung 248 provides inflation or hydraulic energy to the everting catheter system. Hydraulic energy may be supplied by saline, air, a combination of saline and air, or gases such as CO2, contrast agents, media, and other fluids. During operation, the hydraulic energy can be in the range of 2 to 4 atmospheres or 1 to 6 atmospheres. Inner catheter 8 is translatable within outer catheter 4 to advance and retract the everting membrane (not visible). At the proximal end of the inner catheter 8 is a proximal hub 246 designed to pass the IUD suture 252. In other embodiments, it may not be necessary to expose the IUD sutures from the inner catheter.

[0192] FIG. 12B shows the distal end of the everting catheter, with the IUD 254 visible within the everting membrane only partially everted from the acorn-shaped tip 242. IUD 254 may be folded within membrane 6. IUD suture 252 may be proximal to IUD 254. IUD suture 252 may be within the central lumen of inner catheter 8. IUD 254 may have a rounded distal end 256 and a shaft 258. The IUD 254 may have a radiopaque marker band 260, a copper or drug or hormone elution area 262, and other features.

[0193] FIG. 12C shows the IUD 254 being pulled by advancement of the everting membrane 6 through the distal end of the outer catheter 4 and the opening in the acorn-shaped tip 242. Everting of the membrane may be performed in response to hydraulic energy or water pressure within the everting catheter system 2 via the inflation tube and bung (not shown). The everting membrane 6 rolls inside out in response to hydraulic energy. Advancement of the everting membrane 6 can be performed by the user translating the inner catheter (not visible) or automatically in response to hydraulic energy. The everting membrane can have dimensions in the range of 1 mm to 5 mm in diameter in the cervix, or in the range of 4.0 to 4.5 mm in outer diameter when pressurized to 2 atmospheres. The everting membrane has an outer diameter range of 2 mm to 7 mm and a wall thickness of 0.001 inch to 0.004 inch or 0.0015 inch. The everting membrane may be made from irradiated polyolefin, polyurethane, Pebax, silicone, or other flexible membrane materials. The everting membrane wall thickness can range from 0.002 inch to 0.010 inch depending on the modulus of the membrane material.

[0194] FIG. 12D depicts the distal end of the outer catheter 4 and the acorn-shaped tip with the everting membrane 6 in a further stage of abduction and the IUD 254 advanced through the distal opening of the acorn-shaped tip 242. Showing 242. The rounded end 256 of the IUD 254 is in the early stages of returning to its natural state relative to the folded state. In its natural state, the IUD 254 may have a "T" or "Y" shape, although other shapes and configurations are possible for intrauterine devices.

[0195] Figure 12E shows completion of the abduction process. The everting membrane 6 has been advanced further past the acorn-shaped tip 242, completely exposing the IUD 254. The IUD 254 at this point may be in its natural (ie, unbiased or mechanically relaxed) state or in a "T" shape. The shaft 258 and hormone or drug eluting portion 262 are completely exposed from the distal end of the membrane 6. Certain IUDs include a band or ring of copper material as a spermicide. The IUD suture 252 may still be present within the central lumen of the membrane 6 and the inner catheter (not visible). Once the IUD 254 is completely exposed outside the membrane 6, it can reach its insertion depth within the uterine cavity. The depth of insertion of the IUD 254 within the uterine cavity is determined or defined by the length of the membrane 6 and the amount of eversion performed by the user during translation of the inner catheter 8 (which may vary depending on the desired depth of insertion). obtain. Additionally, the outer catheter 4 may be configured with a telescoping tube (not shown) that allows the membrane length and insertion depth within the uterine cavity to be varied.

[0196] FIGS. 13A-13I illustrate additional derivatives for everting catheter system 2 for IUD placement. FIG. 13A shows the everting catheter system 2 with the IUD 254 folded within the everting membrane 6 (not visible) within the outer catheter 4. Inner catheter 8 can be placed proximal to Y fitting 244 and continues within outer catheter 4. The everting membrane 6 may be connected to the distal end of the inner catheter 8 and the distal end of the outer catheter 4. An acorn-shaped tip 242 can be placed at the distal end of the outer catheter 4. The everting membrane 6 can be pressurized with fluid, gas, or a combination thereof via the extension tube and bung 248. There may be a pusher 264 within the inner catheter 8 that may be proximal to the inner catheter hub 246. Pusher 264 may be a hollow tube with a pusher hub 266 and may receive IUD suture 252 within the lumen.

[0197] FIG. 13B shows the acorn-shaped tip 242 in a side view, with the dashed line indicating the through lumen 276 within the acorn-shaped tip. Using the acorn-shaped tip 242, the everting catheter system 2 can be placed in the cervicovaginal region of the patient. The acorn-shaped tip 242 includes a rounded surface 269 on the front and an intubation tip 268 on the back that can be designed to purchase or cannulate a cervical opening. Acorn-shaped tip 242 may have an outer shoulder 270 that provides a stop mechanism to avoid inadvertent insertion of outer catheter 4 into the patient's cervical canal. Distal opening 272 may be configured to allow the everting membrane to deliver the IUD (both not shown).

[0198] FIGS. 13C and 13D illustrate another type of acorn-shaped tip 242. The acorn-shaped tip 242 has a low-profile front surface 274 with an outer shoulder 270 that reduces the front circumference of the acorn-shaped tip 242 . The low-profile anterior surface 274 provides the clinician with a wide viewing angle of the cervicovaginal region when placing an everting catheter (not shown). By using the low-profile front surface, physicians can improve visualization of the cervicovaginal region while maintaining the functionality of the acorn-shaped tip for cervicovaginal cannulation, ensuring a secure hold, and preventing inadvertent insertion of the external catheter into the cervix. A stop mechanism can be provided to prevent inward advancement. An alternative acorn-shaped tip 242 may include an intubation tip 268 at the distal end of the posterior surface, along with a bevel 271 leading to a shoulder 270, to facilitate initial device placement in the cervicovaginal region of the patient. The dashed line shows a through lumen 276 with a distal end opening 272.

[0199] Returning to an alternative embodiment of everting catheter system 2, FIG. This shows that the IUD 254 is being advanced by the everting membrane 6. At the same time, the pusher 264 can be advanced with the abducens membrane 6, with the two IUD sutures 252 exiting the pusher hub 266.

[0200] FIG. 13F shows that the IUD 254 is further advanced by the everting membrane 6 and the inner catheter 8 is translated within the outer catheter 4. When the membrane is everted and the IUD is pulled forward, the rounded end 256 is exposed distally at the end of the everting membrane 6.

[0201] FIG. 13G shows the IUD 254 released from the everting membrane 6 and in its fully natural state, ie, a "T" or "Y" shape. IUD suture 252 can be placed proximal to the IUD and extends through the abducens membrane 6, pusher 264, and inner catheter (not visible). Pusher 264 advances IUD 254 past the distal end of abducens membrane 6 to complete release of the IUD.

[0202] FIGS. 13H and 13I illustrate an alternative embodiment of the distal end of pusher 264. FIG. 13H shows the distal end of pusher 264 with pusher cup 278 having a concave opening 280 to receive and retain the contours of the proximal end of IUD 254 (not shown). Pusher 264 may have a lumen with a central axis 282. Distal end pusher cup 278 facilitates handling and loading of IUD 254 within an everting catheter (not shown).

[0203] FIG. 13I shows an alternative configuration of the distal end of the pusher 264 with a through lumen and a central shaft 282 with a split tube opening 284 at the distal end. Split tube opening 284 may be configured to open and receive and retain the proximal end of IUD 254 (not shown). Distal end split tube opening 284 facilitates handling and loading of IUD 254 within an everting catheter (not shown).

[0204] FIGS. 14A-14D show the IUD 254 advancing from the folded state to the unfolded state within the everting membrane 6 and returning to its natural state or "T" shape. FIG. 14A shows the everting membrane 6 advancing through the acorn-shaped tip 242 and pulling the IUD 254 in its collapsed, low-profile state within the everting catheter system 2. In response to hydraulic energy supplied through the extension tube and plug (not visible), the rounded end 256 is compressed by the everting membrane 6.

[0205] FIGS. 14B and 14C further illustrate advancement of the IUD 254 within the everting membrane 6 within the everting catheter system 2. The IUD 254 can return to its natural state, ie, a "T" or "Y" shape, when pulled by the everting membrane. Figure 14B shows the everting membrane 6 under pressure due to hydraulic energy. The IUD suture 252 can be housed within the split opening 284 within the distal end of the pusher 264.

[0206] FIG. 14D shows another embodiment of an everting catheter system 2 in which hydraulic energy can be removed by a pressure source 286 via an extension tube and bung 248. Once the hydraulic energy is removed from the abduction catheter system 2, the abduction membrane 6 can no longer grasp the IUD 254 and the pusher 264 can advance the proximal end of the IUD beyond the distal opening of the abduction membrane. . The pressure source 286 can be an inflation device as shown, or other device such as a syringe, a syringe and flexible tubing, a pump, or a pressurized canister or container.

[0207] Figure 15A shows an everting catheter system 2 with a one-handed delivery mechanism. At the proximal end of the everting catheter system 2, a housing 288 can be configured with a rotating wheel 290 and an outer catheter release button 292. At the distal end, an acorn-shaped tip 242 can be designed to engage the cervicovaginal region when placed in a patient for IUD delivery and placement. IUD 254 is visible within outer catheter 4. The extension tube and bung 248 may be located at the rear of the housing 288. Pusher 264 and pusher hub 266 extending from the proximal portion of housing 288 are visible with IUD suture 252 protruding from the through lumen of pusher 264.

[0208] FIG. 15B demonstrates a one-handed operation mechanism of everting catheter system 2 using housing 288. The operator's thumb can be placed on the rotating wheel 290 in close proximity to the outer catheter release button 292. The IUD 254 is visible within the outer catheter 4 and the pusher 264 with a pusher hub 266 extending from the proximal portion of the housing is visible.

[0209] FIG. 15C shows a top view of the one-handed mechanism of everting catheter system 2, with inner catheter 8 within housing 288 visible. Inner catheter hub 246 is also visible with pusher 264 protruding from its proximal portion. IUD suture 252 is visible protruding from the proximal opening of pusher hub 266. Also visible within the housing 288 are a pusher stop 294 and a gear housing 296 under the operator's thumb.

[0210] FIG. 15D further illustrates, in a top view, one-handed operation of the abduction catheter system 2 as the abduction membrane 6 is advanced and the IUD 254 is pulled through the acorn-shaped tip 242. A rotating wheel 290 (partially visible under the operator's thumb) can be used to advance the inner catheter 8 to advance the everting membrane. Once inner catheter hub 246 reaches gear housing 296, advancement of everting membrane 6 may be limited. Inner catheter 8 can be advanced into outer catheter 4 so that inner catheter hub 246 advances pusher 264 until it reaches gear housing 296 and pusher hub 266 mechanically engages pusher stop 294 . In operation, with the pusher 264 remaining in place relative to the housing 288 by the pusher stop 294, the operator actuates the outer catheter release button 292 to release the outer catheter 4 and its attached everting membrane 6. to retreat. This causes the distal end of pusher 264 to advance IUD 254 from the distal end of abducens membrane 6, releasing IUD 254 within the uterine cavity. In operation, the operator removes the entire everting catheter system 2 and advances the IUD suture 252 through the pusher 264.

[0211] FIGS. 16A-16J illustrate another embodiment of an everting catheter system 2 with a handle 30. FIG. The outer catheter 4 may protrude distally to the handle 600 and the pusher 264 may protrude proximally to the handle with the IUD suture 252 extending from the pusher hub 266. At the front of the handle 600 there may be an inner catheter button 298 and an outer catheter release button 292. An extension tube and bung 248 may protrude from the rear of the handle 600 (partially visible).

[0212] FIG. 16B shows inner catheter button 298 advanced within housing slot 308 on the front surface of housing 288. An inner catheter button 298 is attached to the proximal end of an inner catheter (not shown), and its advancement translates the inner catheter and everting membrane to deliver the IUD (not shown). In operation, inner catheter button 298 advances until it engages outer catheter release button 292 on the front surface of housing 288.

[0213] FIG. 16C shows retraction of the outer catheter release button 292 to effect release of the IUD from the abduction catheter (not shown).

[0214] FIG. 16D provides information regarding how the housing 288 operates with the abduction catheter system 2 to effectuate advancement and release of the IUD (not shown). In FIG. 16D, the front of the housing 288 is removed to show the interior of the everting catheter system 2, including the inner catheter hub 246. Alternatively, it is possible to remove inner catheter hub 246 with inner catheter button 298, or have both devices as shown. Also visible are pusher 264 and pusher hub 266 with IUD suture 252 exiting the proximal portion of the pusher hub. The outer catheter release button 292 and inner catheter button 298 are also visible, and in this position advancement of the everting membrane (not shown) is complete. Housed at the rear of the housing 288 is an inflation tube slot 300 and a pusher engagement tab 302 configured to mechanically retain the pusher hub 266 upon completion of the eversion phase. Also visible are housing holes 304 designed to clasp the front and rear portions of housing 288.

[0215] FIG. 16E shows a cutaway view of the proximal portion of the Y fitting 244, with the inner catheter 8 emerging from the proximal portion of the Y fitting. An extension tube and bung 248 (bung not shown) extends rearwardly from Y fitting 244 through housing 288 and through inflation tube slot 300. Outer tube release button 292 is mechanically attached to Y fitting 244 and can be retracted along inflation tube slot 300 within housing 288.

[0216] FIG. 16F shows another cutaway view of the inflation tube slot 300 on the rear surface of the housing 288. An extension tube and bung 248 (bung not shown) are visible within inflation tube slot 300.

[0217] FIG. 16G shows a cutaway view of the proximal portion of the housing 288 and the proximal aperture 306. A cutaway view of the pusher 264 emerging from the proximal portion of the inner catheter hub 246 can be seen. Visible on the inner rear surface of the housing 288 is an inner path of a pusher engagement tab 302 that gradually narrows from the proximal to the distal portion of the housing 288. Pusher hub 266 may have a conical or tapered profile at a distal portion for advancing within pusher engagement tab 302. The flat proximal portion of pusher hub 266 can act as a proximal mechanical detent after pusher hub 266 extends beyond pusher engagement tab 302.

[0218] FIG. 16H shows the initial steps of IUD delivery and placement with another cutaway view of the right side of housing 288. Outer catheter 4 is distal to Y fitting 244 and attached to outer catheter release button 292. There is also an inner catheter button 298 within the housing slot 308 on the front of the housing. A pusher 264 extends proximally to the inner catheter 8 and inner catheter button. Attached to the proximal end of the pusher 264 is a pusher hub 266 with a lumen therethrough for the IUD suture 252.

[0219] FIG. 16I shows the same advancement range of the inner catheter button 298 during an abduction step in which the abduction catheter system 2 is hydraulically pressurized via the extension tube and bung 248 (bung not shown). Shown in cutaway view. This embodiment shows 12.6 cm of advancement of the inner catheter 8 within the outer catheter 4. This advancement distance corresponds to an insertion depth within the uterine cavity of 6.3 cm. Other advancement lengths from 3cm to 24cm are possible. Furthermore, the insertion depth can be controlled by the physician by stopping the everting step at any point during the process.

[0220] FIG. 16J shows the release step of the IUD delivery process using everting catheter system 2. Outer catheter release button 292 is retracted to pass pusher 264 through inner catheter 8 and advance the IUD (not shown) through the abducens membrane (not shown).

[0221] FIGS. 17A-17I illustrate another embodiment of an abduction catheter for delivering an IUD. FIG. 17A shows everting catheter system 2 with a housing 288, with pusher 264 and pusher hub 310 extending proximally relative to the housing. The pusher hub 310 receives a syringe 74 or other irrigation source to deliver fluid, saline, contrast media, ultrasound media, drugs or therapeutic agents, or gas or configured to provide air. The irrigation fluid or medium can facilitate visual identification of the cervicovaginal region or uterine cavity by ultrasound or fluoroscopy.

[0222] Figure 17B shows the abduction catheter system 2 in the early stages of the abduction process. The front of housing 288 has been removed to identify internal components and mechanisms.

[0223] FIG. 17C shows everting catheter system 2 being supplied with hydraulic energy via an extension tube and bung 248. Inner catheter button 298 is advanced to translate inner catheter 8 within outer catheter 4. The everting membrane 6 extends distally to the acorn-shaped tip 242 and pulls the IUD (not shown) and pusher 264 through the central lumen of the everting catheter system 2. The pusher hub 310 translates through the proximal hole 306 of the housing 288 and into the path of the pusher engagement tab 302.

[0224] Figure 17D shows the next step in the abduction process. The inner catheter button 298 has engaged the outer catheter release button 292 and the pusher hub 310 has reached the mechanical detent of the pusher engagement tab 302.

[0225] Figure 17E shows the next step in the IUD delivery process. A syringe 74 is connected to the extension tube and bung 248 to draw negative pressure within the everting catheter system 2. Hydraulic energy within the everting membrane 6 is extracted by negative pressure.

[0226] Figure 17F shows the next step in the IUD delivery process. Outer catheter release button 292 is retracted, thereby retracting outer catheter 4, everting membrane 6, and inner catheter 8 while maintaining the position of pusher 264 relative to housing 288. Pusher engagement tab 302 prevents pusher hub 310 from retracting, thereby maintaining its position relative to housing 288.

[0227] FIG. 17G shows an enlarged photograph of the distal end of the abducens membrane 6. Hydraulic energy is removed from everting catheter system 2 with the distal end of pusher 264 extending beyond the distal opening of everting membrane 6. A split tube opening 284 is at the distal end of the pusher 264, indicating that the distal end of the pusher 264 can extend from the everting membrane 6.

[0228] FIG. 17H shows an alternative type of syringe 74 with a plunger spring 314 on the plunger 76. Engagement button 312 can be translated within syringe housing 208 and secured on ridge 316 in multiple positions relative to plunger 76. Engagement button 312 can lock plunger spring 314 in a compressed state when pressed.

[0229] FIG. 17I shows engagement button 312 released, plunger spring 314 extended and plunger 76 retracted to provide negative pressure within syringe 74 and everting catheter system 2 (not shown). The syringe 74 is shown in condition.

[0230] FIGS. 18A-18C illustrate another embodiment of everting catheter system 2. FIG. This everting catheter system 2 automatically applies negative pressure to remove hydraulic energy within the everting catheter during the step of releasing the IUD (not shown) during the delivery and deployment procedure. FIG. 18A shows an everting catheter system 2 comprising a housing 288 and a syringe 74 mounted or attached to the lower rear surface of the housing. Syringe 74 may have a plunger spring 314 in a compressed state and an engagement button 312 secured within syringe housing 208. The syringe 74 is connected via an inflation tube 318 as a conduit for hydraulic energy within the everting catheter system 2 .

[0231] FIG. 18B shows advancement of inner catheter button 298 within housing slot 308. Advancement of the inner catheter button 298 translates the inner catheter (not shown) within the outer catheter 4 and advances the everting membrane and IUD (both not shown).

[0232] Figure 18C shows the next step in the IUD delivery and placement process. When outer catheter release button 292 is pressed, engagement button 312 releases plunger spring 314 and plunger 76, creating negative pressure within everting catheter system 2 via inflation tube 318. At this point, the outer catheter release button can be retracted along housing slot 308 to retract the outer catheter 4, everter membrane, and inner catheter (not shown), while the pusher (not shown) position is maintained and the IUD is released from the abducens membrane (both not shown).

[0233] FIG. 19A shows everting catheter system 2 for delivering an IUD in an inverted state. The IUD 254 can be loaded into the balloon membrane (not visible) and into the inner catheter 8 in a collapsed state. Inner catheter 8 may be placed within outer catheter 4. A movable flange at the distal end of the outer catheter 4 can be an insertion depth marker with an indication 402. At the proximal end of the outer catheter 4 there is a T-fitting 244 for everting balloon pressurization with an X-ring valve (not shown) for translation of the inner catheter 8. Inner catheter 8 has a proximal hub 246 that can be a luer connector, knob, or handle for manipulating the inner catheter. Within the central lumen of inner catheter 8 is a pusher 264 with a lumen for one or more IUD sutures 252. Pressurization of everting catheter system 2 can be performed by syringe 410 and syringe plunger 409. Syringe 410 and syringe plunger 409 may be connected to connector 413 by a user or physician. Connector 413 may be connected to flexible tube 412. Pinch clamp 411 may be used by the user or physician to close flexible tube 412 and maintain pressure within the everting balloon. After pressurization, the syringe 410 can be removed and removed from the abduction catheter system 2 before insertion into the patient.

[0234] FIGS. 19B-19D are enlarged views of various portions of everting catheter system 2. FIG. FIG. 19B is an enlarged view of the distal end of outer catheter 4, with the first portion of everting balloon 6 extending from the distal end of outer catheter 4 visible. The distal end opening of the outer catheter 4 has an acorn-shaped tip, or rather a smooth, rounded, low-profile distal tip. The distal end may have instructions 402 showing, for example, 7 cm, 8 cm, 9 cm, and 10 cm marks, to provide a user (eg, physician) with an indication of insertion depth. Movable flange 401 can be positioned by a user (eg, a physician) to provide visual and tactile indicators of insertion depth. Inside the outer catheter 4, the IUD 254 can be seen folded and loaded in a low-profile state within the everting balloon and the inner catheter (not visible).

[0235] FIG. 19C is an enlarged view of the pressurization system for everting catheter system 2. Pressurization of the abduction catheter 2 may be performed by a syringe 410 filled with saline, sterile water, air, or an inert gas or a combination of gas and fluid media. When the user or physician presses the syringe plunger 409, hydraulic energy is delivered to the everting balloon. Syringe 409 can have a volume of, for example, 1 cc, 3 cc, 5 cc, or 10 cc, with 3 cc in the illustrated example. Other volumes are also possible. Pressurization of everting catheter system 2 may cause flexible tube 412 to expand. Flexible tube 412 is made from silicone and/or other elastomeric materials such as polyurethane, rubber, and TPE, or combinations thereof. The flexible tube 412 can maintain approximately constant pressure within the everting catheter system 2 during inversion and eversion. Because the silicone tube can continue to expand in response to added water pressure, the flexible tube 412 can reduce the user or physician's inadvertent application of excessive pressure within the abduction catheter system 2. The amount of pressurization is 1 to 4 atm, and the nominal level can be 2 atm. The amount of compliance within a silicone tube can depend on the durometer of the material, the wall thickness of the tube, and the tube length available for expansion. For example, as shown, the flexible tube 412 can be silicone with a hardness of 50A, a length of 6 cm, an outer diameter of 4.75 mm, and a wall thickness of 1 mm. The pressurization system can be closed by a user using a pinch clamp 411 to close the lumen of the flexible tube 412 after pressurization with a syringe 410, for example. Other tube closure devices may also be used, such as bungs, gate valves, roller clamps, or combinations thereof. In place of or in combination with the connector 413, a one-way check valve or Luer activation valve may be placed on the flexible tube 412 to allow pressurization in one direction, thereby connecting the flexible tube 412 and eversion. The need for the user to actuate a closure device to close the catheter system 2 and maintain pressure therein can be eliminated. Water pressure provided by syringe 410 and syringe plunger 409 is in fluid communication with abduction catheter system 2 via a T-fitting 244 with an Pressure can be maintained during translation of the inner catheter 8 within. Inner catheter 8 may be made from nylon, Pebax, polypropylene, polyethylene, or combinations thereof. Inner catheter 8 can extend from the distal end of the fully everted balloon to the proximal end of t-fitting 244, which has an outer diameter of 4 mm and an inner diameter of 3 mm.

[0236] Figure 19D shows an enlarged view of the proximal portion of everting catheter system 2, illustrating inner catheter 8 with proximal connector hub 246 having a central through hole. Within this central through hole there may be a pusher 264 with a pusher hub 266 having a central through hole through which the IUD suture 252 passes. Proximal connector hub 246 and pusher hub 266 can be luer connectors for injecting fluid, saline, or gaseous media to distend the uterine cavity for ultrasound, fluoroscopic, or endoscopic visualization. syringe or tubing can be connected. Proximal connector hub 246 and pusher hub 266 can be handles or knobs for a user or physician to manipulate the catheter. Pusher 264 may be made from nylon, Pebax, polypropylene, polyethylene, or combinations thereof. The tube of the pusher 264 can have an outer diameter of 2 mm, an inner diameter of 1.25 mm, and a length close to the total length of the everting catheter system 2, such as when a user or physician Allows the IUD to be released from 8.

[0237] FIG. 20A shows everting catheter system 2 after the balloon has been fully everted in the process of delivering the IUD. IUD 254 may be in a loaded state, folded within inner catheter 8 and everting balloon 6. Outer catheter 4 may include indicator marks 402 and insertion depth marker flange 401. The outer catheter 4 can be connected to a T-fitting 244 with an can be connected to a flexible tube 412 with Immediately proximal to the fitting 244 there may be a proximal connector hub 248 that exhibits full eversion of the abduction balloon and full translation of the inner catheter (not visible). Proximal to proximal connector hub 248 is a pusher 264 and pusher hub 266. Proximal to the pusher hub 266, the IUD suture 252 can be seen extending beyond the central lumen of the tube.

[0238] FIG. 20B is an enlarged view of the distal end of everting catheter system 2 with fully everted balloon 6 and IUD 254. The distal end of the inner catheter (not visible) can be connected to everted balloon 6, and the rounded distal end 256 of IUD 254 can be just distal to fully everted balloon 6. Through the abduction balloon 6 and inner catheter, portions of the IUD 254 are visible, including the copper wire 271, the IUD shaft hole 272, the suture knot 273, and the IUD suture (not visible). The everting balloon 6 may be connected to the outer catheter 4 having indicator marks 402. For example, the everting balloon 6 may be 6 cm long to traverse the length of the cervix, and 3.5 cm long from the cervicovaginal region to the internal cervical os. Different lengths of the everting balloon 6 can be used to approximate the uterine length of various patients. For example, an epidermal balloon has an outer diameter of 4 mm when pressurized to 2 atmospheres, and thousands of thousands of inch) wall thickness. The everting balloon may be made from irradiated polyolefin, polyethylene, Pebax, polyurethane, other biocompatible materials capable of producing a hydraulic everting balloon, or combinations thereof.

[0239] The distal end of the inner catheter (not visible) can have an inner diameter that allows, for example, a collapsed IUD to fit within the tube. For example, a 3 mm inner diameter allows a collapsed IUD to fit within the tube, while the rounded distal end 256 remains protruding distally relative to the inner catheter (not visible) and the abduction balloon 6. . The distal end of the pusher (not visible) may be immediately proximal to the IUD shaft hole 272 and suture knot 273. The distal end opening of the everting balloon 6 may be connected to the distal end of the inner catheter (not visible). When everted and pressurized, the everting balloon 6 can collapse the IUD 254 into a low-profile state and assist in its advancement through the cervical canal and into the uterine cavity. The rounded distal end 256 also has a low profile for advancement into the uterine cavity, e.g., through the everting catheter system 2, the distal end opening of the outer catheter 4, and the cervical canal when the everting balloon 6 is everted and pressurized. It can be folded and compressed.

[0240] FIG. 20C is an enlarged view of the proximal portion of everting catheter system 2 after it has been fully everted in the process of delivering IUD 254. The outer catheter 4 can be connected to a T-fitting 244 with an X-ring (not visible) and is fluidly coupled to a flexible tube 412. Tube pinch clamp 411 is shown in a closed state, and the interior of abduction catheter system 2 is pressurized by water pressure. The proximal connector hub 248 is immediately proximal to the t-fitting 244 and can, for example, exhibit full eversion of an abduction balloon (not shown) and full translation of an inner catheter (not visible). can. Within the proximal connector hub 248 is a pusher 264 with a pusher hub 266 at its proximal end, with the IUD suture 252 visible extending through the central lumen of the pusher 264.

[0241] FIGS. 21A-21C depict a simulated uterine cavity model 500 (for illustrative purposes, a proxy for the patient's uterine cavity and each other anatomical structure) using a metric scale 510 for reference. The process of delivering the IUD within the FIG. 21A shows placement of an IUD 254 within a simulated uterine cavity model 500. Model 500 includes a uterine fundus 501 that simulates the cranial apex of the uterine cavity, as well as cornual regions 502 (indicating the patient's right tubal ostium) and 503 (indicating the patient's left tubal ostium). has. The simulated uterine cavity model may include a lower uterine segment 504 with a simulated cervix 505 and a simulated cervicovaginal region 506. The abduction balloon 6 of the abduction catheter system 2 is fully everted, with the rounded distal end 256 of the IUD 254 proximal to the fundus 501 of the uterine cavity and distal to the abduction balloon 6. obtain. Pusher 264 may be proximal to IUD 254. The flange 401 abuts the cervicovaginal region 506, and the insertion depth may be, for example, about 9 cm.

[0242] FIG. 21B illustrates the next (eg, intermediate) step in the IUD deployment process using everting catheter system 2. At this point, the everting catheter system 2 can be retracted 1.5 cm, as shown by the flange 401, which is at a distance of, for example, 1.5 cm from the cervicovaginal region 506. Therewith, the IUD 254 may be released from the distal end of the everting balloon 6 by retraction of the pusher 264 and everting catheter system 2. A rounded distal end 256 of IUD 254 may extend outward toward corner regions 502 and 503.

[0243] FIG. 21C shows the next (eg, last) step of IUD 254 placement using an everting catheter system (not shown) that can be completely removed from the simulated uterine cavity model 500. Rounded distal end 256 can remain within corner regions 502 and 503. The IUD suture 252 is visible extending from the cervicovaginal region 506. The user or physician can trim the excess length of the IUD suture 252 depending on the amount of excess IUD suture or the type of IUD.

[0244] 22A to 22E illustrate a packaging configuration for shipping and loading of everting catheter system 2 for IUD delivery. The everting catheter system 2 may be placed on the pouch card 600 in a fully everted position with the IUD 254 placed at the distal end of the everting balloon (not visible). Pouch card 600 and everting catheter system 2 may be placed in a sealed pouch (not shown) for sterilization, delivery, and eventual use by a physician. Pouch card 600 can be made from clean laminated cardboard, PETG, polypropylene, polyvinyl chloride, PET, or combinations thereof. A protective tube 601 can be attached to the pouch card 600, which can be, for example, 6.5 cm long and has an internal diameter of 4 mm. The length of the protective tube 601 covers the fully everted balloon (not visible) and maintains the IUD 254 in an open configuration so that the rounded distal end 256 extends beyond the distal end of the protective tube 601. It can be set as follows. The inner diameter of the protective tube 601 can be sized to allow an unpressurized everting balloon (not visible) to slide through the central lumen. When the everting balloon (not visible) is pressurized, the everting balloon outer diameter may contact the inner lumen of the protective tube 601. Contacting the lumen when pressurized allows the everter balloon and inner catheter to be easily retracted, eg, by the user or physician, for loading or preparation for use. The protective tube 601 can be made from nylon, but can also be formed from polypropylene, PET, Pebax, and other tubing materials used in medical device packaging. With the inner catheter (not visible) fully translated into the outer catheter 4, the t-fitting 244 and proximal connector hub (not visible) may be held in place by the pouch tab 602. Pusher 264, pusher hub 266, and IUD suture 252 may extend proximally to abduction catheter system 2.

[0245] FIG. 22B is an enlarged view of the distal portion of the pouch card 600 and the deformation of the protective tube 601 with the everting balloon (not visible) fully everted within the protective tube 601. The IUD 254 is in an open configuration and positioned at the distal end of the abduction catheter system 2, allowing the IUD suture (not visible in this view) to extend the entire length of the inner catheter and pusher of the abduction catheter system 2. The proximal end of the protective tube 601 can be cannulated into the distal end of the outer catheter 4.

[0246] FIG. 22C shows steps in preparing the everting catheter system 2 (eg, unpackaging, assembly, and pressurization). Pouch 603 can be partially peeled off to expose the proximal portion of pouch card 600. A user or physician can connect syringe 410 to flexible tubing 412 with pinch clamp 411 in the open position. The flexible tube can be rotated upwardly, ie perpendicular to the surface or pouch card 600. The everting catheter system can be pressurized with 3 cc of saline.

[0247] FIG. 22D shows that the flexible tube 412, pressurized by the pinch clamp 411, can be in the closed position with the syringe removed and removed from the Luer connector 413. The IUD suture 252 can then be pulled to retract the IUD 254 within the distal end of the inner catheter (not visible) within the protective tube 601.

[0248] FIG. 22E is an enlarged view of the distal portion of the pouch card 600, where the IUD 254 can be in a loaded configuration folded inside the inner catheter (not visible) within the protective tube 601. The abduction balloon (not visible) is then fully inverted with the inner catheter (not visible) fully translated back, e.g. Catheter system 2 can be removed.

[0249] Any element described herein as singular can be plural (ie, anything described as "1" can be two or more). Any species element of a genus element may have the characteristics or elements of any other species element of that genus. The medium delivered herein can be any of the fluids described herein (eg, liquids, gases, or combinations thereof). All patents and patent applications cited herein are incorporated by reference in their entirety. For clarity of illustration, some elements may not be present in the individual figures. The above-described structures, elements, or complete assemblies and methods for carrying out the present disclosure and variations of aspects of the present disclosure, and the elements thereof, can be combined and modified with each other in any combination. . All devices, apparatus, systems, and methods described herein can be used for medical (eg, diagnostic, therapeutic, or rehabilitation) or non-medical purposes.

[0250]

[0251] U.S. Patent No. 9,028,401 filed May 12, 2015, U.S. Patent No. 9,101,391 filed Aug. 11, 2015, U.S. Patent No. 10,034,986 filed July 31, 2018, 2019-1 No. 2019/0009058 published on July 10, 2020, No. 2020/0206463 published on July 2, 2020, No. 202/0297384 published on September 24, 2020, and January 2020. No. 2020/0023162 published on May 23rd is incorporated herein by reference in its entirety.

[0252] Any element described herein as singular can be plural (ie, anything described as "1" can be two or more). Any species member of a genus member may have the characteristics or elements of any other species member of that genus. In this specification, "dilation" and "dilation" are used interchangeably. The medium 155 delivered herein can be any of the fluids described herein (eg, liquids, gases, or combinations thereof). All patents and patent applications cited herein are incorporated by reference in their entirety. For clarity of illustration, some elements may not be present in the individual figures. The above-described structures, elements, or complete assemblies and methods for carrying out the present disclosure and variations of aspects of the present disclosure, and the elements thereof, can be combined and modified with each other in any combination. . All devices, apparatus, systems, and methods described herein can be used for medical (eg, diagnostic, therapeutic, or rehabilitation) or non-medical purposes.