Apparatus and method for everting catheter for IUD delivery and placement in uterine cavity

Abstract

Disclosed is an everting balloon system that can be used to place an IUD within the uterine cavity of a female patient.SOLUTION: An everting balloon system can be used with an IUD to access the uterine cavity at a specific location on the fundus of the uterus. A single-handed IUD delivery system for placement by an everting catheter is disclosed. An IUD loading system for placement within an everting catheter is disclosed. Everting catheters with IUDs can simplify the IUD placement process in the uterine cavity.SELECTED DRAWING: Figure 12E

Description

[Technical Field]

[0001]

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

[0002] The apparatus and methods disclosed herein may have utility for everting catheters, which are characterized by an inner catheter, an outer catheter, and an everting membrane that can be connected to both catheters. The inner catheter may include a lumen for passage of fluids or media, drugs or therapeutic agents, instruments or devices, such as intrauterine devices (IUDs), endoscopes, and other catheters.

[0003] For physicians and medical professionals, access systems to a patient's vessels and body cavities typically involve the use of various guidewire and catheter technologies. In some cases, this process requires the insertion of a series of mandrels or wires to expand the diameter of the lumen in order to ultimately pass a larger diameter instrument through the vessel. This technique is sometimes called "Dottering." Alternatively, in the case of accessing the cervix and uterus, physicians use a series of diameter-expanding mandrels known as Hegar dilators. In the above-mentioned techniques, the method involves pushing an object, mandrel, or device into the 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 shear force can cause trauma and pain to the patient, or can result in perforation.

[0004] In contrast, another access technique used in the prior art is called an eversion catheter, which utilizes a traversing action in which the balloon is inverted and rolls inside out or everts under the influence of hydraulic pressure generated by a compressible or incompressible fluid or medium, driven by a propulsive force within the vessel. Everting balloons, also known as rolling or outrolling balloons, everting membranes, toposcopic catheters, or linear eversion catheters, are described, for example, in U.S. Patent Nos. 5,364,345, 5,372,247, 5,458,573, 5,472,419, 5,630,797, 5,902,286, 5,993,427, 6,039,721, 3,421,509, and 3,911,927, all of which are incorporated herein by reference in their entirety. These are classified as everting balloons and are intended for frictionless traversal of vessels, lumens, tubes, or ducts. In other words, everting balloons are capable of traversing a vessel without exerting shear forces on the wall being traversed. This action, and the absence of shear forces, can result in less trauma and a reduced risk of perforation. Additionally, the mechanism of advancement through the vessel results in no material within the proximal portion of the duct or vessel being pushed or advanced forward toward the distal portion of the duct or vessel.

[0005] Furthermore, when an eversion catheter is deployed inside-out, 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 are not accessible to the patient or physician. When the balloon is pressurized and everted, the balloon material rolls inside-out without contacting any elements of the extravascular entrance. During IUD delivery, the eversion-rolling action of the balloon material prevents the IUD from contacting elements of the patient's vaginal wall, exocervix, cervical canal, and, depending on insertion depth, the internal cervical os. Another advantage of eversion 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 duct, as opposed to the need to "push" a standard catheter into the vessel or duct. For IUD delivery, the force of hydraulic pressure "pulls" the balloon membrane and IUD through the cervix and into the uterine cavity, as opposed to the need to "push" a standard IUD catheter tube through the cervix and into the uterine cavity.

[0006]

[0006] The method physicians typically use to access a woman's cervix requires the use of multiple instruments of increasing diameter to access the uterine cavity with larger devices. Physicians use a small uterine sound, or small-diameter probe, or Hegar device to initially enter the uterus through the cervix. The expanding size of the Hegar device is used to stretch the cervical 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 nulliparous women seeking contraception with an IUD or some women who choose to use a hormonal IUD to reduce abnormal bleeding. There may also be postmenopausal women whose cervix is ​​extremely small in diameter. Crossing the cervix can be difficult as a result of previous surgery, underlying stenosis, or other anatomical configurations or kinks that make it difficult for instruments or Hegar dilators to pass through.

[0007] Some cervical dilators expand radially to open the cervical canal and increase its internal diameter without inserting multiple instruments. All of these devices require that the cervical canal be first traversed or crossed before the radial expansion step. Once the cervical canal is crossed, these devices use concentric mechanical means or balloon expansion members external to the dilator probe. If the cervical canal is particularly tight or narrow, a small diameter probe or mandrel may be required to first traverse the cervix to access the uterine cavity. The smaller the diameter of the mandrel or instrument, the greater the chance of perforation or mispassage. In any case, these cervical dilators require an initial probe passage or traversal before performing the radial expansion.

[0008]

[0008] Eversion catheters are also known as dilating catheters. Representative examples of dilating eversion catheters include U.S. Patent Nos. 5,364,345 and 4,863,440, both of which are incorporated herein by reference in their entirety.

[0009]

[0009] Eversion catheters have also been described with additional elements, such as handles, for controlling instruments within the eversion catheter. A representative example is U.S. Pat. No. 5,346,498, the entire contents of which are incorporated herein by reference. Eversion balloon catheters can be constructed with an inner catheter having a through-lumen or a thru-lumen. The thru-lumen can be used to pass instruments, media, substances, therapeutic agents, endoscopes, guidewires, or other instruments or devices. Representative examples of eversion catheters with a thru-lumen are U.S. Pat. Nos. 5,374,247 and 5,458,573. Furthermore, eversion catheters have been described with a constriction or narrowing of the balloon diameter, such as in U.S. Pat. No. 5,074,845, the entire contents of which are incorporated herein by reference.

[0010]

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

[0011] One common gynecological procedure is the placement of an IUD in women seeking temporary birth control or medication for abnormal uterine bleeding, menstrual cramps, or other medications that can be implanted into the uterine cavity through an intrauterine device that elutes a hormone-relieving drug. IUDs may contain copper and can be constructed in many configurations. In all of these cases, a physician must place the device into the uterine cavity.

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

[0013] In clinical applications, during device placement, the cervix can have multiple bends and curvatures, including tight-radius curves. To place the device through the cervix and straighten the cervix to reduce the amount of curvature, the physician grasps the cervix and maintains countertraction against the cervix. In addition to straightening the cervix, countertraction facilitates pushing the IUD insertion device through the cervical canal and into the uterine cavity. Misplacement, perforation, or failure to place the IUD are all known and commonly accepted consequences or adverse events of the IUD placement procedure. Additionally, the stiffness of the cannula or IUD implant itself can cause 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. As the insertion device slides out of the cervix, the IUD's retrieval suture(s) remain within the patient's cervical canal. After removal, the physician trims any excess sutures visible extending from the cervicovaginal cavity. Because the IUD sutures are visible in the patient's vagina extending from the cervicovaginal cavity, they can be trimmed to the length indicated on the IUD manufacturer's label.

[0016]

[0016]

[0017] Additionally, when delivering reproductive material, such as IUDs, instruments, devices, and embryos, into the uterine cavity, the access system can push cervical mucus and vaginal material into the uterine cavity. These fluids and vaginal material can promote bacterial infection. The balloon expansion action is designed to minimize this effect.

[0017]

[0018] Furthermore, access systems for the uterine cavity can create a vacuum effect when withdrawn or removed from the cavity. This vacuum effect can unintentionally remove reproductive material from the uterine cavity in the context of embryo transfer. In existing systems, when a transfer catheter is retracted from a second outer or guide catheter (e.g., an "inner" catheter), this retraction creates vacuum pressure within the uterine cavity. This vacuum pressure is created within the uterine cavity by the removal and retraction of the transfer catheter within the inner catheter. After the embryo transfer is completed, 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 the vacuum effect. Once this catheter is removed, the same procedure can be performed on the outer catheter. Having a system that can reduce the vacuum effect during IUD placement could result in more reliable and accurate IUD placement.

[0018]

[0019] Also, in the action represented by an eversion balloon, the balloon is in an inverted state and rolls inside out, or everts, under the influence of hydraulic pressure generated by a compressible or incompressible fluid or medium. Eversion balloons are also called rotating or outer rotating balloons, eversion membranes, topographic catheters, or linear eversion balloons. All of these are classified as eversion balloons because of their ability to traverse vessels, cavities, ducts, or ducts substantially frictionlessly. Eversion balloons are capable of traversing ducts without exerting significant shear forces on the walls they traverse. Because of this action and the absence of shear forces, material within the proximal portion of the duct or vessel is not pushed or advanced toward the distal portion of the duct or vessel. For example, in an eversion balloon for the female reproductive tract, potentially infectious material from the vagina, cervical os, or cervicovaginal region, or from the patient's arms or other anatomical structures, and the physician's hands during insertion or catheter preparation, does not come into contact with the everted balloon within the catheter system prior to deployment within the patient. The purpose of keeping the eversion balloon isolated from potentially dirty surfaces is to reduce post-procedure infection. Summary of the Invention

[0019]

[0020] An eversion balloon system is disclosed. The eversion balloon system can be used for IUD placement, instrument, device, and endoscopic delivery, as well as for insemination, urinary incontinence, body cavity dilation, access and sealing within a body cavity, or combinations thereof. The system can have automatic deployment and disengagement. The system can have a handle for insertion. The system can have a motorized air or fluid pump or pressure source. The system can have inner and outer catheters that can automatically disengage upon eversion.

[0020]

[0021] The eversion balloon system may have an intubation base with a fixed balloon that can be activated when pressurized. The system may be a compact, low-profile unit for in vivo use. The system may be disposable for single use. The system may be non-inflammatory and non-infectious.

[0021]

[0022] The eversion balloon system can be used for cervical access, dilation, and IUD delivery. The eversion balloon system can have a system handle mechanism that allows a user to use a one-handed operation technique. The one-handed operation technique can include advancing and pressurizing the eversion balloon membrane within the user's one-handed control.

[0022]

[0023] The eversion balloon system can be used for insertion of a drug delivery device or for insemination, and can seal the cervix for a period of time to place drugs or sperm and to allow patient mobility. The eversion balloon system can have a separation mechanism configured to separate the outer and inner catheters while maintaining hydraulic pressure within the eversion balloon. The system can simultaneously deflate and remove the eversion balloon.

[0023]

[0024] The system can be used to place or deliver a tubal insert (i.e., an intrafallopian tube insert, such as Bayer Corporation's Essure device) into the fallopian tube. The system has access to the intramural and isthmus of the fallopian tube. All or part of the eversion catheter system can be loaded onto a hysteroscope and placed using direct endoscopic visualization.

[0024]

[0025] The eversion catheter system can be a selective fallopian tube catheter with a curved distal end and a beveled ball tip. This configuration can be performed with ultrasound or radiography.

[0025]

[0026] One or more tubal occlusion devices (e.g., Essure devices) can be loaded into the eversion balloon system, e.g., through the inner catheter lumen. Once fully everted and positioned within the fallopian tube, the eversion balloon system, e.g., the inner catheter, can be withdrawn from the fallopian tube, leaving the tubal occlusion device in the fallopian tube. Once the eversion balloon system is withdrawn from the fallopian tube, the tubal occlusion device can be deployed (e.g., by stretching a device fixation portion, such as a coil, or by expanding an elastic porous matrix to create a friction fit within the lumen). After the tubal occlusion device is deployed, the central guidewire can be removed from the fallopian tube. This procedure can be repeated for the contralateral fallopian tube.

[0026]

[0027] The eversion balloon system can be used to access the bladder, ureter, kidney, or a combination thereof. Devices, tools, instruments, endoscopes, drugs, therapeutic agents, sampling devices (brushes, biopsies, and suction mechanisms), or a combination thereof can be delivered to the target site through the inner catheter lumen.

[0027]

[0028] Specialized eversion catheter systems in which specific instruments, tools, or functions are constructed or disposed within the eversion catheter system are also disclosed herein. Examples of such tools or instruments include biopsy devices, cytology devices, drug delivery mechanisms, fluid delivery mechanisms, endoscopes, IUDs, or other tools delivered to a body cavity, body space, potential body space created by the eversion balloon mechanism, or a body vessel. Constructing or disposing an IUD within an eversion catheter system as a delivery mechanism has several advantages. The eversion balloon can be used to pull the IUD implant into the uterine cavity without the need for a physician or operator to push an insertion device through the cervico-vaginal cavity and into the uterine cavity. This is particularly useful in tortuous or narrow cervixes. Furthermore, the eversion membrane rolls evertally within the passageway without friction, without exerting shear forces on the lumen wall. The eversion balloon functions to protect the body passageway from the contours of the IUD's distal end while pulling the IUD to the desired position.

[0028]

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

[0029]

[0030] The IUD placement procedure can be performed or delivered to a specific location within the uterine cavity.

[0030]

[0031] An eversion membrane for IUD placement can be designed for one-handed placement.

[0031]

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

[0032]

[0033] Everting membranes for IUD placement can be designed for one-handed placement using automatic or manual irrigation through a central lumen during IUD release. Automatic irrigation can assist device placement by releasing the IUD from the everting membrane. Irrigation through a central lumen before loading the IUD into an everting catheter or before delivering and releasing the IUD in the everting membrane increases lubrication within the everting membrane, allowing the IUD to slide out of the everting membrane with less friction. Having irrigation capabilities in everting catheters for IUD delivery and placement is particularly useful because hormonal drugs, coatings, or other therapeutic agents contained in some IUDs can become sticky if they interact with the surfaces of certain polymers that are useful in catheter manufacturing.

[0033]

[0034] The irrigation mechanism, whether automated or manual, can be used to aid in visualization of the device within the uterine cavity using ultrasound, fluoroscopy, or direct endoscopic visualization through the central lumen of the IUD insertion device. As an example, injecting saline through the central lumen with the irrigation mechanism allows a physician to perform ultrasound visualization of the IUD within the uterine cavity to confirm IUD placement in a slightly distended uterine cavity.

[0034]

[0035] The IUD system may have a transfer mechanism that facilitates loading of a commercially available or second-party IUD into the eversion catheter. Once the IUD is loaded, the eversion catheter is ready for placement within the patient's uterus. The transfer mechanism includes a loading device that retrograde loads the second-party IUD into the distal end of the eversion membrane and a snare for capturing and retracting the IUD sutures through the central lumen of the eversion catheter. The entire mechanism is housed within a flat stand that attaches to a standard procedure preparation table. In operation, the loading mechanism can facilitate loading of the second-party IUD within the eversion catheter prior to delivery into the patient.

[0035]

[0036] The eversion catheter system for the IUD placement procedure can be assisted by a suction system to hold onto the device during the initial steps of device loading. The suction system operates through the central lumen of the eversion catheter in conjunction with the distal end opening of the pusher, allowing the eversion membrane of the eversion catheter system to stabilize and pull the IUD into place.

[0036]

[0037] An eversion catheter system for an IUD placement procedure can 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 can be independently altered and selected for insertion depth for IUD placement without modifying other components of the eversion catheter system.

[0037]

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

[0038]

[0039] The IUD loading system allows a user to load a separately supplied IUD into an eversion catheter system. The loading system may include a cradle, a split tube, and a tray fixture that facilitates loading of the IUD into the eversion catheter system.

[0039]

[0040] Another embodiment uses a derivation of the loading system within the manufacturing process during construction of the eversion system integral with the preloaded IUD. [Brief explanation of the drawings]

[0040] [Figure 1A]

[0041] FIG. 10 is a longitudinal cross-sectional view of the distal end of a variation of a method for using an eversion balloon system. [Figure 1B]

[0041] A longitudinal cross-sectional view of the distal end of a variation of a method for using an eversion balloon system. [Figure 1C]

[0041] A longitudinal cross-sectional view of the distal end of a variation of a method for using an eversion balloon system. [Figure 1D]

[0041] A longitudinal cross-sectional view of the distal end of a variation of a method for using an eversion balloon system. [Figure 1E]

[0041] A longitudinal cross-sectional view of the distal end of a variation of a method for using an eversion balloon system. [Figure 2A]

[0042] 10 illustrates a variation of the eversion balloon system in a fully everted configuration. [Figure 2B]

[0043] 10A and 10B are cross-sectional views of variations of the system handle. [Figure 3A]

[0044] 13 shows a deformation of the distal end of an eversion balloon system in a configuration where the dilatation balloon is not fully inflated. [Figure 3B]

[0045] 13 shows a deformation of the distal end of the eversion balloon system with the dilatation balloon in a fully inflated configuration. [Figure 4A]

[0046] 10 shows a variation of the eversion balloon system in a syringe-attached but not yet deployable configuration. [Figure 4B]

[0047] 10 shows a variation of the eversion balloon system in a deployable configuration with a syringe attached. [Figure 4C]

[0048] FIG. 4C illustrates a variation of the eversion balloon system of FIG. 4B in which the plunger driver is shown in cutaway. [Figure 5A]

[0049] 10 shows the deformation length of the eversion balloon system. [Figure 5B]

[0050] FIG. 5B is a partial cross-sectional view of a variation of the system of FIG. 5A. [Figure 5C]

[0051] 1 is a modified side view of a portion of the AA section. [Figure 5D]

[0051] This is a modified perspective view of a portion of the AA cross section. [Figure 5E]

[0052] FIG. 10 is an exploded view of a variation of a portion of the system handle and drive gear. [Figure 5F]

[0053] FIG. 10 is an enlarged view of the deformation of the system handle in the ratchet handle shaft. [Figure 6A]

[0054] 10A and 10B are cross-sectional views of variations of the system handle. [Figure 6B]

[0055] FIG. 6B is a side view of a variation of the eversion balloon system using the system handle of FIG. 6A. [Figure 6C] FIG. 6B is a top perspective view of a variation of the eversion balloon system using the system handle of FIG. 6A. [Figure 6D]

[0055] FIG. 6B is a cross-sectional view of a variation of the eversion balloon system using the system handle of FIG. 6A. [Figure 7A]

[0056] FIG. 10 is an exploded view of a variation of the eversion balloon system. [Figure 7B]

[0056] A perspective view of a variation of the eversion balloon system. [Figure 8A]

[0057] 10A-10C are cross-sectional views of variations of a three-way connector and abutment element configured to deliver media pressure to an outer catheter, for example, an eversion balloon. [Figure 8B]

[0058] 10A-10C are cross-sectional views of variations of a three-way connector and adjacent element configured to deliver media pressure to an inner catheter, for example, to a dilatation balloon. [Figure 9]

[0059] FIG. 10 is an exploded view of a variation of the transfer catheter. [Figure 10A]

[0060] A variation of the method is shown for delivering material to a target site, for example, delivering reproductive material into the uterine cavity. [Figure 10B]

[0060] A variation of the method is shown for delivering material to a target site, for example, delivering reproductive material into the uterine cavity. [Figure 10C]

[0060] A variation of the method is shown for delivering material to a target site, for example, delivering reproductive material into the uterine cavity. [Figure 11A]

[0061] A variation of the method is shown for delivering material to a target site, for example, delivering reproductive material into the uterine cavity. [Figure 11B]

[0061] A variation of the method for delivering material to a target site is shown, for example, delivering reproductive material into the uterine cavity. [Figure 11C]

[0061] A variation of the method for delivering material to a target site is shown, for example, delivering reproductive material into the uterine cavity. [Figure 12A]

[0062] 1 shows an eversion catheter for performing an IUD placement procedure via the eversion membrane. [Figure 12B]

[0062] An eversion catheter for performing an IUD placement procedure via the eversion membrane is shown. [Figure 12C]

[0062] An eversion catheter for performing an IUD placement procedure via the eversion membrane is shown. [Figure 12D]

[0062] An eversion catheter for performing an IUD placement procedure via the eversion membrane is shown. [Figure 12E]

[0062] An eversion catheter for performing an IUD placement procedure via the eversion membrane is shown. [Figure 13A]

[0063] The distal end of the everting membrane and additional outgrowth incorporated into the inner catheter are shown in side view. [Figure 13B]

[0063] The distal end of the everting membrane and additional derivatives incorporated into the inner catheter are shown in side view. [Figure 13C]

[0063] The distal end of the everting membrane and additional derivatives incorporated into the inner catheter are shown in side view. [Figure 13D]

[0063] The distal end of the everting membrane and additional derivatives incorporated into the inner catheter are shown in side view. [Figure 13E]

[0063] The distal end of the everting membrane and additional derivatives incorporated into the inner catheter are shown in side view. [Figure 13F]

[0063] The distal end of the everting membrane and additional derivatives incorporated into the inner catheter are shown in side view. [Figure 13G]

[0063] The distal end of the everting membrane and additional derivatives incorporated into the inner catheter are shown in side view. [Figure 13H]

[0063] The distal end of the everting membrane and additional derivatives incorporated into the inner catheter are shown in side view. [Figure 13I]

[0063] The distal end of the everting membrane and additional derivatives incorporated into the inner catheter are shown in side view. [Figure 14A]

[0064] 10 shows another embodiment demonstrating advancement and release of an IUD within the eversing membrane. [Figure 14B]

[0064] Another embodiment is shown demonstrating advancement and release of an IUD within the eversed membrane. [Figure 14C]

[0064] Another embodiment is shown demonstrating advancement and release of an IUD within the eversed membrane. [Figure 14D]

[0064] Another embodiment is shown demonstrating advancement and release of an IUD within the eversed membrane. [Figure 15A]

[0065] 1 shows an automatic one-handed eversion mechanism for IUD placement. [Figure 15B]

[0065] An automatic one-handed eversion mechanism for IUD placement is shown. [Figure 15C]

[0065] An automatic one-handed eversion mechanism for IUD placement is shown. [Figure 15D]

[0065] An automatic one-handed eversion mechanism for IUD placement is shown. [Figure 16A]

[0066] 1 shows a variation of an eversion catheter capable of delivering an IUD into the uterine cavity. [Figure 16B]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 16C]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 16D]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 16E]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 16F]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 16G]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 16H]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 16I]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 16J]

[0066] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 17A]

[0067] 1 shows a variation of an eversion catheter capable of delivering an IUD into the uterine cavity. [Figure 17B]

[0067] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 17C]

[0067] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 17D]

[0067] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 17E]

[0067] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 17F]

[0067] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 17G]

[0067] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 17H]

[0067] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 17I]

[0067] A variation of an eversion catheter capable of delivering an IUD into the uterine cavity is shown. [Figure 18A]

[0068] A mechanism for automatically applying negative pressure during the IUD release step of the delivery process is shown. Additionally, perfusion through the central lumen can be performed separately or in conjunction with negative pressure to assist in the IUD release step. [Figure 18B]

[0068] A mechanism for automatically applying negative pressure during the IUD release step of the delivery process is shown. Additionally, perfusion through the central lumen can be performed separately or in conjunction with negative pressure to assist in the IUD release step. [Figure 18C]

[0068] A mechanism for automatically applying negative pressure during the IUD release step of the delivery process is shown. Additionally, perfusion through the central lumen can be performed separately or in conjunction with negative pressure to assist in the IUD release step. [Figure 19A]

[0069] 1 shows an eversion catheter system for delivering an IUD. [Figure 19B]

[0070] FIG. 1 is a close-up view of the eversion catheter system. [Figure 19C]

[0070] An enlarged view of the eversion catheter system. [Figure 19D]

[0070] An enlarged view of the eversion catheter system. [Figure 20A]

[0071] 1 shows the eversion catheter system after full eversion of the balloon in the process of delivering the IUD. [Figure 20B]

[0072] FIG. 1 is a close-up view of the distal end of the everted balloon and IUD. [Figure 20C]

[0073] FIG. 10 shows a close-up view of the proximal portion of the eversion catheter system after complete eversion in the process of reaching the IUD. [Figure 21A]

[0074] 1 illustrates the process of delivering an IUD within a simulated uterine cavity model. [Figure 21B]

[0074] The process of delivering an IUD within a simulated uterine cavity model is shown. [Figure 21C]

[0074] The process of delivering an IUD within a simulated uterine cavity model is shown.

[0075] [Figure 22A]

[0076] 1 illustrates a packaging configuration for shipping and loading an eversion catheter system for delivering an IUD. [Figure 22B]

[0076] A packaging configuration for shipping and loading an eversion catheter system for delivering an IUD is shown. [Figure 22C]

[0076] A packaging configuration for shipping and loading an eversion catheter system for delivering an IUD is shown. [Figure 22D]

[0076] A packaging configuration for shipping and loading an eversion catheter system for delivering an IUD is shown. [Figure 22E]

[0076] A packaging configuration for shipping and loading an eversion catheter system for delivering an IUD is shown. DETAILED DESCRIPTION OF THE INVENTION

[0041]

[0077] An eversion balloon system 2 (also called an eversion catheter system) is disclosed that can be used to traverse vessels such as the cervical canal. The eversion 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 stretched or dilated. The eversion balloon system 2 can have a control system that can be operated with one hand. The eversion catheter system can also traverse other locations within a patient or animal's body for the purpose of placing devices within a body cavity or lumen.

[0042]

[0078] 1A to 1E show that the everting catheter system 2 can have a radially outer catheter 4, a balloon membrane 6, and a radially inner catheter 8. The inner catheter 8 can have an inner catheter lumen 10 (e.g., a through lumen). The distal end of the inner catheter lumen 10 can be open or closed. The inner catheter 8 can have the inner catheter lumen 10 or can be a solid rod or a flexible mandrel. The everting balloon system 2 can have a media volume 12. The media volume 12 can be a continuous open volume between the inner catheter 8 and the outer catheter 4 proximal to the balloon membrane 6. The radially outer periphery of the balloon membrane 6 can be attached to the distal end of the outer catheter 4. The radially inner periphery of the balloon membrane 6 can be attached to the distal end of the inner catheter 8. It is also possible to make the everting balloon system 2 without the inner catheter 8, for example, with the balloon membrane 6 extending proximally from the operating area to a control device (e.g., a pump).

[0043]

[0079] 1A shows that the eversion catheter system 2 can be in an unpressurized configuration. The medium volume 12 can be uninflated and unpressurized. The balloon membrane 6 can be in a relaxed state.

[0044]

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

[0045]

[0081] The balloon membrane 6 can be inflated and pulled taut, occluding the distal portion of the inner catheter lumen 10.

[0046]

[0082] 1C shows that the eversion catheter system can be inflated to a partially everted configuration. The inner catheter 8 can be translated distally relative to and out of the outer catheter 4, as indicated by arrow 16. The distal end of the inner catheter 8 can be proximal to the distal end of the balloon membrane 6. The distal end of the inner catheter 8 can be proximal or distal to the distal end of the outer catheter 4. The balloon membrane 6 can either block the distal portion of the inner catheter lumen 10 or open it to allow fluid communication between the inner catheter lumen 10 and the target site.

[0047]

[0083] 1D shows that the eversion catheter system may be in an inflated, fully everted, and fully distally extended configuration. The inner catheter 8 may be translated distally relative to the outer catheter 4, as indicated by arrow 16, until the distal end of the inner catheter 8 terminates longitudinally beyond or with the distal end of the balloon membrane 6. The distal portion of the inner catheter lumen 10 is unobstructed and accessible for fluid communication with the target site.

[0048]

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

[0049]

[0085] The balloon outer diameter 20 can be about 2 mm to about 20 mm, more narrowly about 2 mm to about 7 mm, e.g., about 5 mm. The outer diameter can be constant or variable along the length of the everting balloon 18. For example, for use in the cervical canal, the most proximal portion of the everting balloon outer diameter 20 can be configured with a smaller outer diameter than the remainder of the everting balloon membrane 24. By way of example, a first proximal portion of the everting balloon 18 can have a smaller outer balloon diameter 20, e.g., about 2 mm to 4 mm, over a length of about 5 mm to about 10 mm from the distal end of the outer catheter 4. The remainder of the length of the everting balloon 18 (e.g., about 4 cm to about 7 cm along the everting balloon 18) can have an outer balloon diameter 20 of about 4 mm to about 7 mm. The outer diameter of the proximal end of the eversion balloon 18 may have a consistent balloon outer diameter 20 of about 3 mm to about 6 mm, for example, for delivery in the cervix or urethra, and the outermost distal end of about 2 cm to about 3 cm of the eversion balloon 18 may have a balloon outer diameter 20 of about 10 mm to about 20 mm, for example, for sealing and securing the internal os of the uterine cavity or the bladder.

[0050]

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

[0051]

[0087] The eversion balloon length 22 can be from about 2 cm to about 31 cm, or narrower ranges of about 2 cm to about 25 cm (e.g., for use in the male urethra), from about 2 cm to about 12 cm for IUD placement, and narrower ranges of about 3 cm to about 6 cm for in vitro fertilization, insemination procedures, or instrument and endoscopic delivery, such as about 4 cm, about 7 cm, about 15 cm, and about 30 cm.

[0052]

[0088] 1E shows that the eversion catheter system can be inflated to a partially or fully everted configuration. As indicated by arrow 28, a device or tool 26, a liquid, a gas, or a combination thereof, can be translated through the inner catheter lumen 10 from the distal portion of the inner catheter lumen 10 to the target site. The tool 26 can be an IUD, a biopsy tool, a scope, a sonogram probe, a plug, an ablation tool, or a combination thereof. Aspiration can be directed from the proximal end of the inner catheter lumen 10 to the target site, for example, to remove debris from the target site through the inner catheter lumen 10.

[0053]

[0089] To retract, reposition, or remove the balloon membrane 6, the inner catheter 8 can be pulled proximally, pulling 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 can be withdrawn from the target site.

[0054]

[0090] 2 shows that the eversion balloon system 2 can have a system handle 30. The system handle 30 can have a system handle connector 32. The system handle 30 can be attached to the outer catheter 4 and the inner catheter 8, for example, at the system handle connector 32. The system handle connector 32 can be removably attached to the outer catheter 4. For example, the outer and inner catheters 4, 8 and balloons can be removed from the system handle 30 and replaced. The system handle 30 can be sterilizable. Prior to attachment or replacement of the catheters and balloons, the system handle 30 can be filled with a medium (e.g., liquid or gas) to be delivered by the system handle 30.

[0055]

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

[0056]

[0092] The system handle 30 may have an inlet 40. The eversion balloon system 2 may have a pressurized source, which may include a flexible liquid reservoir 42 or a fluid supply container or bladder. The fluid bladder may be filled with hydraulic and / or pneumatic fluid.

[0057]

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

[0058]

[0094] The liquid reservoir 40 may be in one-way or two-way fluid communication with the media volume 12 (eg, via a check valve).

[0059]

[0095] If the fluid reservoir 42 contains fluid, expansion of the fluid reservoir 42 may rotate the pump lever 36 away from the system handle case 34, as indicated by the pump lever rotation arrow 46. Rotating the pump lever 36 toward the system handle case 34 may compress the fluid reservoir 42, for example, forcing fluid from the fluid reservoir 42 into the media volume 12 of the eversion balloon 18.

[0060]

[0096] The pump lever 36 can perform a pumping (e.g., suction) action that provides suction to draw fluid from the media volume 12 of the eversion balloon 18. A spring within the lever can facilitate the pumping action of the lever and open the lever with each compression (not shown).

[0061]

[0097] The system handle 30 can have an advancement slide 48. The advancement slide 48 can translate proximally and distally relative to the system handle case 34, as indicated by arrow 50. The advancement slide 48 can be configured to translate the inner catheter 16 relative to the outer catheter 4. For example, pushing the advancement slide 48 distally pushes the inner catheter 8 distally relative to the outer catheter 4, everting the eversion balloon 18. Pulling the advancement slide 48 proximally pulls the inner catheter 8 proximally relative to the outer catheter 4, retracting the eversion balloon 18. The advancement slide 48 can include a gear, a ratchet with a rack, and a rotary advancement screw.

[0062]

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

[0063]

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

[0064]

[0100] The fluid reservoir 42 can be pressurized before placing the distal tip of the outer catheter 4 in the neck. The fluid reservoir 42 can have a proximal check valve or one-way valve at the proximal portion of the handle. The proximal check valve is the connection point for the physician to pressurize 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 equal to or exceeds the distal check valve's threshold pressure, such as approximately 1 atmosphere from the fluid reservoir, and can then deliver fluid and pressure from the fluid reservoir 42 to fill and pressurize the catheter's media volume 12 and eversion balloon 18. The distal pressure check valve 52 can be a one-way valve, allowing hydraulic or pneumatic fluid or media to be delivered from the fluid reservoir 42 to the catheter's media volume 12 and eversion balloon 18. Distal pressure check valve 52 can have pressure values ​​higher or lower than 1 atmosphere, for example, between about 0.5 atmospheres and about 2 atmospheres.

[0065]

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

[0066]

[0102] The distal pressure valve 52 can be connected to a three-way connector 56 (e.g., a Y-connector or a T-connector) having a hemostasis valve 58, such as a Touhy-Borst valve, so that the fluid reservoir 42 can stage or maintain additional potential hydraulic pressure stored within the system for use as needed by a user (e.g., a physician) by rotating the pump lever 46 without having to reposition or use their other hand.

[0067]

[0103] The inner catheter 8 can extend through a three-way connector 56. The inner catheter 8 can be translated (i.e., advanced and retracted) through the three-way connector 56 while maintaining a seal (i.e., without the catheter's media volume 12 and eversion balloon 18 losing pressure). The inner catheter 8 (e.g., if it is a solid rod or mandrel) can be configured to withstand water pressures of up to about 5 atmospheres or up to about 10 atmospheres during the eversion process and to withstand translational (e.g., advancement, retraction, tension, compression, or a combination thereof) forces of up to about 2 pounds or up to about 5 pounds without deformation. As an example, during the eversion process, the inner catheter 8, having an inner catheter lumen 10 (e.g., a through lumen), can withstand media pressures 14, tension and compression forces, and rotational forces as the eversion balloon membrane 6 traverses curved or tortuous anatomical structures, allowing for the passage of instruments, catheters, media, or substances through the through lumen. Acting an advance button on the handle moves the inner catheter 8 within the three-way connector 56 and through the outer catheter 4. The eversion balloon 18 can then evert and roll out of the outer catheter 4 and across the target site (eg, the cervical canal).

[0068]

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

[0069]

[0105] After the eversion balloon 18 has traversed the biological lumen to be traversed (e.g., the cervix or urethra), the eversion balloon system 2 can increase the pressure within the eversion balloon 18, for example to expand the diameter of the eversion balloon 18, or to maintain a constant diameter of the eversion balloon 18 (e.g., in the case of a fiber-reinforced eversion balloon 18 or a balloon membrane 6 constructed of a less distensible material). The pump lever 36 can be compressed to increase the pressure generated within the fluid reservoir 42 and exit the distal pressure check valve 52. The proximal check valve 54 can prevent or minimize leakage or flow of fluid medium (e.g., air or water pressure) proximally out the inlet 40.

[0070]

[0106] The user can rotate the pump lever 36, for example, to increase the pressure in the fluid reservoir 42, the media volume 12, and the eversion balloon 18. The outer diameter of the balloon then increases, further expanding the diameter of the biological lumen. For example, the eversion balloon 18 can dilate the cervix and cervical canal. Tools such as an endoscope, an instrument, a Hegar dilator, other devices that further increase the diameter of the cervix, or a combination thereof can then be inserted into the dilated cervical canal, either simultaneously with the eversion balloon system 2 being positioned within the cervical canal or after the eversion catheter system 2 has been withdrawn from the cervical canal.

[0071]

[0107] The pump lever 36 can provide tactile feedback to the user indicating the pressure in the eversion balloon 18. The eversion balloon system 2 can include a pressure gauge that indicates the pressure in the fluid reservoir 42 and / or the media volume 12 of the catheter and the eversion balloon 18.

[0072]

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

[0073]

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

[0074]

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

[0075]

[0111] The pressure relief control and handle allow the user to advance and deliver the IUD with one hand.

[0076]

[0112] The user can perform the following operations of the eversion balloon system 2 with one hand (e.g., without the use of the other hand or another operator) without changing hand position. a. Pressurize the liquid reservoir 42. b. Position or place the distal end of the eversion balloon system 2 on the patient's neck. c. Controls the position of the eversion balloon system 2 during use. d. Advance the inner catheter 8 and balloon membrane 6. e. Expand the diameter of the eversion balloon 18 by pumping more water pressure from the fluid reservoir 42. f. Retract the inner catheter 8 and balloon membrane 6. g. Activate the pressure relief control 60 to remove or release pressure from the eversion catheter system.

[0077]

[0113] Structurally, the buttons or actuators for enabling these functions are located on the handle, allowing the operator to operate these features without having to reposition or use the other hand. For example, advancement and retraction of the inner catheter 8 can be accomplished by a slide mechanism or gear located on the top of the handle, approximately 4 inches from the proximal end of the handle or handle grip. A lever and ratchet mechanism can be located on the bottom of the handle, approximately 2 inches to 4 inches from the proximal end of the handle grip. Additional actuators can be located on the side of the handle grip, approximately 3 inches to 4 inches from the proximal end of the handle grip, or on the top or bottom of the handle grip, approximately 3 inches to 4 inches from the proximal end. The location of the buttons and actuators is easily apparent to the operator without visual confirmation, allowing the user to maintain eye contact with the patient or continue to look at a visualization source, such as an endoscope monitor or ultrasound image.

[0078]

[0114] While using the eversion balloon system 2, the user can use the other hand to manipulate the ultrasound probe, support bar (e.g., when access to the neck is difficult due to anatomical reasons or when the neck is severely tilted backward or forward), stabilize the patient or other instruments, or a combination thereof.

[0079]

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

[0080]

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

[0081]

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

[0082]

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

[0083]

[0119] The exterior of the eversion and / or dilation balloon 18, 62 can be smooth; for example, the balloon can be fabricated by tubing extrusion. The balloon can be blow molded. For example, the outer surface of the balloon can have ridges or other surface protrusions, for example, to increase friction or retention within the target body cavity (e.g., the cervical channel or urethra). The outer diameter of the balloon can be dimensionally varied. For example, the most distal portion of the eversion balloon 18 can be manufactured with a larger outer diameter to accommodate inflation into larger vessel sizes or the bladder.

[0084]

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

[0085]

[0121] 3B shows that the dilation balloon 62 can be inflated by delivering pressurized fluid through the dilation balloon inflation port 64. The dilation balloon 62 can be inflated inside the eversion balloon 18. The dilation balloon 62 can be inflated to a dilation balloon diameter 66.

[0086]

[0122] The dilatation balloon 62 can have a predetermined or molded size and shape. For example, the dilatation balloon 62 can have a dilatation balloon diameter 66. For example, the maximum dilatation balloon diameter 66 or maximum eversion balloon diameter can be about 2 mm to about 1230 mm, and in some applications, the diameter can be up to about 20 mm (e.g., for use in the cervix), a narrower range of about 2 mm to about 10 mm (e.g., for use in the urethra), an even narrower range of about 6 mm to about 12 mm (e.g., for use in the urethra), an even narrower range of about 2 mm to about 7 mm (e.g., for use in the male urethra), or an even narrower range of about 3 mm to about 4 mm (e.g., for use in the male urethra). The dilatation balloon 62 can be inflated to a predetermined outer diameter. (The dilatation balloon outer diameter 66 can be equal to or less than the dilatation diameter required for a body cavity such as the cervix.) The eversion balloon 18 can have a maximum eversion balloon diameter equal to or less than the maximum dilatation balloon diameter 66.

[0087]

[0123] The dilatation balloon 62 can be inflated to the same pressure as the eversion balloon 18 or to a higher pressure than the eversion balloon 18. For example, the dilatation balloon 62 can have a dilatation balloon pressure of about 4 atmospheres to about 12 atmospheres, and up to 20 atmospheres, for example, to disrupt a pathological constriction or pathological condition within a body cavity.

[0088]

[0124] When the dilatation balloon 62 is inflated, it expands to a dilatation balloon diameter 66, allowing the eversion balloon 18 to stretch. The inflation medium within the eversion balloon 18 may remain within the balloon or may be withdrawn before, during, and / or after inflation of the dilatation balloon 62. The frictional force of the eversion balloon membrane 6 against the body cavity in the everted state may, for example, allow the eversion balloon membrane 6 to maintain the position of the dilatation balloon 62 during the dilatation process, preventing the system from unintentionally moving forward or backward within the body cavity during the dilatation process.

[0089]

[0125] If the eversion balloon diameter expands beyond the strain limit of the eversion balloon 18, the dilation balloon 62 may inflate and rupture or break the eversion balloon 18. The inflation medium within the eversion balloon 18 may remain within the balloon or may be withdrawn before, during, and / or after inflation of the dilation balloon 62 and exit the eversion balloon 18 if, for example, the eversion balloon 18 ruptures open.

[0090]

[0126] The eversion balloon 18 can be broken or ruptured along its intended line upon inflation of the dilatation catheter. For example, the eversion balloon 18 can be ruptured by a mechanical device on or within the outer catheter 4, a sharp implement on the proximal portion of the inner catheter 8 that is activated once the dilatation balloon 62 is fully everted and inflated, and / or by further advancement of the inner catheter 8 to release the attachment or bond between the eversion balloon 18 and the inner catheter 8 at the distal end of the inner catheter 8. Breaking or rupturing the eversion balloon 18 can be accomplished by weakening the eversion balloon 18 with mechanical notches or stitches in the balloon membrane 6, such as helical lines, transverse lines, longitudinal lines, or a combination thereof, that tear when a certain strain limit is reached. The eversion balloon membrane 24 can be manufactured with an increased longitudinal axis orientation of the molecular structure by stretching or expanding the membrane along the longitudinal axis of the balloon during the balloon-forming process. This can facilitate longitudinal tearing in the event of a tear or rupture of the everting balloon membrane 24. Radial tearing of the everting balloon 18 can be facilitated by manufacturing the balloon membrane 6 with increased radial orientation of the molecular structure by radially expanding or tautening the balloon membrane 6 during the balloon-forming process.

[0091]

[0127] The system handle 30 can hold inflation media delivered to and from the eversion balloon 18 and the dilation balloon 62. The inflation media can be contained in a fluid reservoir 42 (e.g., a fluid bag or syringe piston). After inflation and eversion of the eversion balloon 18, the inflation media can be delivered to the dilation balloon, for example, via a valve. The system handle 30 can have gears or ratchets configured to advance the inner catheter 8. The outer catheter 4 can extend approximately 25 cm distal to the system handle 30. The system handle 30 and actuator can be controlled with one hand to inflate the eversion balloon 18 and the dilation balloon 62.

[0092]

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

[0093]

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

[0094]

[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. The ratchet handle 68 can include a knob, a trigger, a lever, a pump mechanism, or a combination thereof. The fluid reservoir can be a syringe 74. The syringe 74 can have a volume of about 5 cc to about 20 cc, e.g., 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. The syringe connector 70 can include a distal pressure valve 52. The syringe connector 70 can be rotatably attached to the system handle case 34. The syringe 74 can have a plunger 76 that is longitudinally translatable relative to the remainder of the syringe 74. The syringe 74 can be filled with any medium disclosed herein, such as saline, water, a gas, or a combination thereof. It is possible for the fluid reservoir 42 to have two separate syringes 74, each 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 the eversion balloon 18 and a second syringe can be in fluid communication with the dilation balloon 62.

[0095]

[0131] A syringe 74 can be secured to the syringe connector 70 .

[0096]

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

[0097]

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

[0098]

[0134] 4B shows that the syringe connector 70 and syringe 74 can be rotated, as indicated by the arrows, so that the longitudinal axis of the syringe 74 is parallel or collinear with the longitudinal axis of the outer catheter 4. The syringe connector 70 can be angularly fixed relative to the rest of the system handle 30. The plunger drive plate 72 can be rotated and / or translated so that it contacts or nearly contacts the proximal end of the syringe plunger 76.

[0099]

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

[0100]

[0136] The ratchet handle 68 may have a ratchet that prevents reversal of the direction of the plunger driver, for example, to prevent proximal translation of the plunger 76. A release lever may be rotated or deployed to release the ratchet mechanism, for example, to disengage the assembly, retract the system, or redeploy. The ratchet handle 68 may not have a ratchet or a two-way ratchet that controls the direction of the plunger driver 82, for example, but may instead allow proximal and distal translation of the plunger 76. The plunger drive plate 72 may be fixed to the plunger 76 or may contact but not be fixed to the plunger 76.

[0101]

[0137] Pulling the ratchet handle 68 may depress the syringe plunger 94. Depressing the syringe plunger 94 may force inflation media from the syringe 74 into the media volume 12 of the dilation and / or eversion catheter 18, for example, to pressurize the respective balloons.

[0102]

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

[0103]

[0139] The system handle 30 may have one or more syringe detents 90. The syringe detents 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. The syringe detents 90 may be configured to allow the syringe 74 to slide in and out of the detents perpendicular to the longitudinal axis of the syringe 74.

[0104]

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

[0105]

[0141] The system handle case 34 may have a handle grip 96. The inner catheter 8 may have a linear inner catheter gripping length 98. The inner catheter gripping length 98 may be the length of the inner catheter 8 in a non-abducted state within the handle grip 96. The inner catheter gripping length 98 may be approximately 12 cm of the inner catheter 8 in a non-abducted state, which may correspond to an eversion length of the inner catheter gripping length 98 of approximately 6 cm of the everting balloon membrane 24 (e.g., approximately 50% of the inner catheter gripping length 98). Alternatively, the inner catheter 8 may be wrapped onto a wheel, have an elastic section, or have a section that folds and unfolds to reduce the amount of distance required within the system handle case 34 to accommodate the length of the inner catheter 8 in a non-abducted state.

[0106]

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

[0107]

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

[0108]

[0144] The inner catheter 8 may extend through the access channel 102. One or more tools or fluids may be inserted into or adjacent to the inner catheter 8 via the proximal access port 104 and the access channel 102, and / or aspirate may be applied to the proximal access port 104 and the access channel 102.

[0109]

[0145] The system handle 30 may have one or more drive gears 106. The drive gears 106 may be located on one or both sides of the access channel 102. The drive gears 106 may intrude into or impinge upon the access channel 102. The drive gears 106 may be rotatably attached to the system handle case 34 via a drive gear shaft 108. The drive gears 106 may have a gear portion and a drive gear groove 124. The inner catheter 8 may extend through the drive gear groove 124. The drive gears 106 may push or pull the inner catheter 8 by friction. One or more of the drive gears 106 may extend and be exposed outside the system handle case 34. For example, the exposed drive gears 106 may be rotated by pressing with the palm or fingers (e.g., thumb) of a user's hand. The exposed drive gears 106 may be meshed and engaged with one or more unexposed drive gears 106. Rotating a first one of the drive gears 106 can rotate other drive gears 106 that are meshed and engaged with the first drive gear 106 .

[0110]

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

[0111]

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

[0112]

[0148] The system handle 30 may have a plunger drive rack 116. The plunger drive rack 116 may be attached to the plunger drive plate 72. The plunger drive plate 72 may extend perpendicularly from the proximal end of the plunger drive rack 116. The side of the plunger drive rack 116 facing the plunger drive plate 72 may have one-way or two-way drive teeth 118.

[0113]

[0149] The system handle 30 can 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, the ratchet handle spring 122 can reset the ratchet handle 68 by rotating the ratchet handle 68 forward after the ratchet handle 68 has been pulled.

[0114]

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

[0115]

[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, which can, for example, allow distal translation of the plunger drive rack 116 while preventing 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.

[0116]

[0152] As shown in Figure 5B, the outer catheter 4 can 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.

[0117]

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

[0118]

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

[0119]

[0155] 6C, before deploying the eversion balloon 18, the delivery tube 133 or delivery device can be disconnected from the syringe-loaded connector 132. The delivery tube 133 can be coiled within the handle grip 96 and can connect the syringe 74 and its pressurized media to the three-way connector 56 and hemostasis valve 58 or inlet 40 for the dilatation balloon 62.

[0120]

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

[0121]

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

[0122]

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

[0123]

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

[0124]

[0160] The ratchet handle 68 may have a safety lock hole 136 through which a safety lock having a cable or rod may removably extend to create an interference fit, for example, with the system handle case 34, preventing rotation of the ratchet handle 68 and preventing, for example, unintended or premature delivery of media from the syringe 74.

[0125]

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

[0126]

[0162] The ratchet handle 68 controls a syringe 74 for applying media pressure to the eversion balloon 18 and the dilation balloon 62 and can also independently control the translation of the inner catheter 8 .

[0127]

[0163] 7A and 7B show that the inlet 40 can have a female luer connector. The system handle connector 32 can have a female luer connector. The outer catheter distal tip 78 can have a soft rubber or polymeric acorn tip, which can, for example, help stabilize the eversion system 2 at the opening of the body cavity or prevent unintended advancement of the outer catheter 4 within the body cavity.

[0128]

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

[0129]

[0165] 8A shows that the three-way connector 56 may have a hemostatic valve 58. The three-way connector 56 may have or be a Touhy-Borst connector. The inner catheter 8 may extend through the three-way connector 56.

[0130]

[0166] The three-way connector 56 can have a distal gasket 142 between the reservoir-to-catheter channel 100 and the system handle connector 32. The distal gasket 142 can have a cylindrical distal gasket port 144 extending through the radial center of the distal gasket 142. The distal gasket port 144 can have a distal gasket port diameter.

[0131]

[0167] The three-way connector 56 may have a proximal gasket 146 proximal to the distal gasket 142. The proximal gasket 146 may be disposed between the reservoir-to-catheter channel 100 and a proximal outlet where the inner catheter 8 proximally exits the three-way connector 56. The proximal gasket 146 may have a greater, the same, or lesser compliance than the distal gasket 142. The proximal gasket 146 may have a cylindrical proximal gasket port 148 extending through a radial center of the proximal gasket 146. The proximal gasket 146 may have a proximal gasket port diameter.

[0132]

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

[0133]

[0169] Positive media pressure 14 or flow can be delivered to the three-way connector 56 via the reservoir-to-catheter channel 100, as indicated by the arrows. The inner catheter large diameter length 152 can occlude, block, and / or seal the proximal gasket port 148. Positive media pressure 14 or flow can be delivered 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) to the media volume 12 between the outer catheter 4 and the inner catheter 8, e.g., to the eversion balloon 18.

[0134]

[0170] 8B shows that the inner catheter 8 can be translated distally, as indicated by the arrow, until at least the inner catheter larger diameter length 152 moves into the distal gasket port 144. The inner catheter larger diameter length 152 can slide through the proximal gasket port 148. The inner catheter larger diameter length 152 can occlude, block, and / or seal the distal gasket port 144 and / or the distal gasket 142. A flow of medium 155 from the reservoir-to-catheter channel 100 can enter the inner catheter proximal inflation hole 154. The medium 155 can flow downstream in the inner catheter lumen 10, for example, to the dilatation balloon 62.

[0135]

[0171] An exemplary procedure for delivering an IUD (not shown) or for dilating a body cavity such as the cervix may include the following. 1. The syringe 74 can be loaded into the system handle 30. The system handle 30 can be a single reusable item, and the eversion catheter and syringe filled with media 155 can be attached to the rest of the system prior to use. Alternatively, the system handle 30 can 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 eversion catheter system 2 can be positioned in the cervico-vaginal region. 3. The ratchet handle 68 can be depressed. The first one or two clicks of the ratchet (i.e., when the locking pawl passes the ratchet teeth) can depress the syringe plunger 94, pressurizing the eversion balloon 18. The eversion balloon 18 can be pressurized to 4-6 atmospheres. 4. The ratchet handle 68 can be pushed further (or released, reset to rotatable, and then pushed further). These next multiple clicks of the ratchet handle 68 can indicate advancement of the inner catheter 8. This can be accomplished by the ratchet mechanism rotating gears on the inner catheter 8 and / or translating a linear rack to advance the inner catheter 8. 5. The ratchet handle can be pushed further (or released, reset to rotatable, and then pushed further). The inner catheter 8 can continue to advance until the eversion balloon is fully deployed and everted. The dilation balloon 62 can be positioned at the distal end of the inner catheter 8. 6. The ratchet handle 68 can be further depressed. This next click of the ratchet can depressurize the eversion balloon 18 or deliver an IUD (not shown). 7. The ratchet handle 68 can be further depressed. This next click of the ratchet can change the pressurized outlet of the syringe 74 from the eversion balloon 18 to the dilation balloon 62. Alternatively, this action can deliver an IUD (not shown). This can be achieved, for example, by: a. Rotating the valve by a ratchet mechanism; b. Manually rotating the valve, and / or c. Advance the inner catheter 8 to a position where the inner catheter proximal inflation hole 154 or port is exposed to the inflation medium, for example as shown in Figures 8A and 8B. 8. The ratchet handle 68 can be further depressed. These next multiple clicks of the ratchet may indicate inflation of the dilatation balloon 62. 9. The dilation balloon 62 can rupture the eversion balloon 18 that covers it. 10. The amount of force in the biological lumen dilation can be regulated by a pressure relief valve or by the volume of media 155 that can be placed within the dilation balloon 62. The dilation pressure can be monitored by a pressure gauge in or attached to the system handle case 34. The dilation balloon 62 can dilate the neck to about 6 atmospheres to about 20 atmospheres. The dilation balloon 62 can initially deliver about 10 atmospheres to about 12 atmospheres and reduce the pressure once the neck is dilated and the dilation process is complete. The system can also deliver a known volume of media 155 into the dilation balloon 62 without quantifying or measuring the media pressure 14. 11. The dilation process may be monitored by ultrasound or radiographic imaging. 12. The 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. The syringe plunger 94 may be retracted to draw a vacuum on the inner catheter lumen 10 and the dilation balloon 62, e.g., to loosen the dilation balloon 62 from the neck, and / or to deflate the dilation balloon 62, e.g., to facilitate removal of the eversion balloon system 2 from the neck. 14. If additional dilatation force is desired, for example in the neck, the eversion balloon system 2 can be re-pressurized. For example, if additional stenosis is visualized in the neck, the dilatation balloon 62 can be repositioned and inflated in the area of ​​the additional stenosis.

[0136]

[0172] The eversion catheter system can access a body cavity (e.g., the uterine cavity or fallopian tubes) to deliver or introduce tools (e.g., IUDs and instruments), reproductive (e.g., embryos, products of in vitro fertilization (IVF) or insemination, e.g., hormones) media 155 or substances, contrast agents, dyes, therapeutic agents, sclerosing agents for treating the endometrium, insufflation media, or combinations thereof, into the body cavity. For example, reproductive media can be delivered using a transfer catheter inserted into the uterine cavity via the inner catheter lumen 10.

[0137]

[0173] 9 shows that a transfer catheter 156, or insemination catheter, can have a transfer connector 158, such as a female Luer connector, a strain relief length 160, and a transfer tube 162. The transfer tube 162 can hold reproductive medium. The transfer tube 162 can have a proximal length with a proximal length diameter that is larger than the distal length diameter of the transfer tube 162. A pumping force, such as positive fluid pressure, can be applied through the transfer connector 158 and the strain relief length 160 to expel the contents of the transfer tube 162 into the target site.

[0138]

[0174] A transfer catheter 156 may be attached to or inserted through the inlet 40. The transfer tube 162 may hold an embryo, for example, for in vitro fertilization, or IVF. The embryo transfer catheter 156 may deliver an embryo through the system to the uterine cavity. The transfer catheter 156 may hold sperm and deliver them through the system to the uterine cavity for an intrauterine insemination procedure. The transfer catheter 156 may hold and deliver other substances, drug depositions, therapeutic agents, instruments, endoscopes, cytology brushes, other catheters, or combinations thereof, into the uterine cavity through the system. The transfer catheter 156 may be connected to a vacuum source to aspirate materials from the uterine cavity or other body cavities and lumens.

[0139]

[0175] Prior to everting the eversion balloon 18 within the vessel or body cavity, the inner catheter lumen 10 can be loaded with the transfer catheter 156 and / or material. For example, when delivering reproductive material to the uterine cavity, the transfer tube 162 of the transfer catheter 156 can be loaded with washed and prepared sperm, and the transfer catheter 156 can be placed within the inner catheter lumen 10.

[0140]

[0176] For example, a guidewire can be inserted through the transfer catheter 156 and / or the remainder of the system to guide the tube or system to the target site 164. The guidewire can be used for recanalization.

[0141]

[0177] The inner catheter 8 is extended, allowing the eversion balloon 18 to evert and expand through the cervix into the uterine cavity. Simultaneously or subsequently, the transfer catheter 156 can be advanced through the inner catheter lumen 10 into the uterine cavity. Once fully everted, or once the transfer catheter 156 is extended or exposed beyond the eversion balloon membrane 24 from the inner catheter 8, the reproductive material 166 within the transfer catheter 156 can be deployed by a syringe 74, squeeze bulb, piston, or other pressure system. Simultaneously, a second delivery catheter, such as a second insemination catheter, IVF catheter, or drug delivery catheter, can be inserted into the inlet 40 or the second inlet. The second delivery catheter can be deployed to the target site 164 simultaneously with or subsequently to the transfer catheter 156.

[0142]

[0178] The system handle 30 may have a lead-in area. The lead-in area does not have any steps, edges, irregularities, or restrictions that could obstruct or contact the distal opening of the transfer catheter 156 during passage, allowing the transfer catheter 156 to be easily loaded into the system handle 30, for example, for delivering insemination material. An insemination syringe 74 or pump can be attached to the proximal transfer connector to deliver pressure to the transfer tube 162, for example, to expel reproductive material 166 after the distal port of the transfer catheter 156 is positioned at the target site 164 (e.g., after the eversion balloon 18 is fully deployed). Actuation of the insemination syringe or pump on a pre-loaded transfer catheter 156 can be performed using the same hand that holds and manipulates the components of the eversion catheter system.

[0143]

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

[0144]

[0180] A user can do any or all of the following while using eversion balloon system 2, for example with one hand: a. Pressurize the eversion catheter system b. Positioning the eversion balloon system 2 on the patient's neck c. Maintain the position of the eversion balloon system 2 during the procedure d. Advance the inner catheter 8 and eversion balloon 18 e. After extending beyond the everting balloon membrane 24 or inner catheter 8, present the transfer catheter 156 for placement into a body cavity, such as the uterine cavity. f. Retracting the inner catheter 8 and eversion balloon 18; and / or g. Activate (e.g., toggle) the pressure release lever to remove or release water or air pressure from the media volume 12.

[0145]

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

[0146]

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

[0147]

[0183] 10B shows that the distal end of the transfer catheter 156 can be advanced, as indicated by arrow 170, through the inner catheter lumen 10 and through the balloon check valve 168 to the target site 164. As the transfer catheter 156 moves through the balloon check valve 168, it can pierce or push the balloon check valve 168 open. When the distal end of the transfer catheter 156 is at the target site 164, distal to the balloon check valve 168, the reproductive material 166 loaded within the transfer catheter 156 can be delivered 172 through the distal port of the transfer catheter 156 and into the target site 164, such as the uterine cavity.

[0148]

[0184] 10C shows that after the reproductive material has been placed at the target site 164, the transfer catheter 156 can be retracted through the balloon check valve 168 and the inner catheter lumen 10. As the transfer catheter 156 is retracted through the balloon check valve 168, the balloon check valve 168 can close. The balloon check valve 168 can maintain a seal between the inner catheter lumen 10 and the target site 164 as the transfer catheter advances (170) through the balloon check valve 168, rests within the balloon check valve 168, and is retracted through the balloon check valve 168.

[0149]

[0185] The reproductive material 166 can be isolated from the vacuum effect or retraction of the reproductive material 166 from the target site 164 as a result of vacuum forces resulting from withdrawing the transfer catheter 156 within the system after placement of the reproductive material 166 is complete. The balloon check valve 168 can remove or eliminate the vacuum effect for embryo transfer.

[0150]

[0186] The balloon check valve 166 can provide a tactile indicator to the physician when threading the transfer catheter 156 through the eversion balloon system 2. During an implantation procedure, the amount of insertion of the transfer catheter 156 through the distal end of the eversion system can vary from patient to patient, depending, for example, on the physician's preference or the patient's anatomy. As the distal end of the transfer catheter 156 passes through the balloon check valve 168, resistance created by the balloon check valve 168 is felt by the physician at the proximal end of the transfer catheter 156. The degree or amount of resistance can be adjusted depending on the length of the balloon selected to act as the balloon check valve 168. In some procedure settings, the ability to inspect the amount of insertion of the transfer catheter 156 into the eversion balloon 18 or the physical depth indication or markings on the proximal end of the transfer catheter 156 can be limited. This limited inspection can be due to dim lighting in the procedure room to enhance monitor imaging and visualization. Additionally, the physical relationship of the physician, embryologist, or other persons or equipment in the procedure room can reduce the ability to easily inspect the amount of insertion into the eversion catheter. The tactile resistance of the balloon check valve 168 can provide a clear indicator that the transfer catheter 156 is at the distal end of the eversion balloon 18 .

[0151]

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

[0152]

[0188] 11A-11C show that the everting balloon membrane 24 can create a seal within the cervical canal (e.g., 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 advances distally, the everting balloon membrane 24 can expand and advance along the cervical wall, as indicated by the arrows. The outer catheter 4 can also seal 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.

[0153]

[0189] 11B shows that the transfer catheter 156 can be advanced distally within the eversion balloon 18 and inner catheter lumen 10. The transfer catheter 156 can place reproductive material 166 (e.g., sperm) within the uterine cavity 176.

[0154]

[0190] 11C illustrates that the transfer catheter 156 and / or the inner catheter 8 can be retracted (e.g., about 3 mm to about 10 mm) or everted, as indicated by the arrows, to close the distal end of the inner catheter lumen 10 relative to the uterine cavity 176, as indicated by the arrows. For example, the distal opening of the eversion balloon 178 can be closed due to pressure within the eversion balloon 18 causing the balloon 18 to form a balloon check valve 168. The balloon check valve 168 can seal the cervix and uterine cavity 176 from the inner catheter lumen 10. The reproductive material 166 can remain within the uterine cavity 176 without being expelled through the cervix.

[0155]

[0191] Figures 12A through 12E show eversion catheters for performing an IUD placement procedure. Figure 12A shows an eversion catheter with an IUD housed within the eversion catheter system 2 in the everted membrane position. The eversion membrane and IUD (not visible in this view) are housed within an outer catheter 4 with an acorn-shaped tip 242 at its distal end. The acorn-shaped tip 242 may have an opening (not visible) at its distal end. At the proximal end of the outer catheter 4 is a T- or Y-fitting 244 containing an X-ring gasket (not visible). An extension tube and stopcock 248 provides inflation or hydraulic energy to the eversion catheter system. The 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. The inner catheter 8 is translatable within the outer catheter 4 to advance and retract the eversion membrane (not visible). At the proximal end of the inner catheter 8 is a proximal hub 246 designed to pass the IUD sutures 252. In other embodiments, the IUD sutures may not need to be exposed from the inner catheter.

[0156]

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

[0157]

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

[0158]

[0194] 12D shows the distal end of the outer catheter 4 and the acorn-shaped tip 242 with the everting membrane 6 in a more advanced eversion stage, advancing the IUD 254 through the distal opening of the acorn-shaped tip 242. The rounded end 256 of the IUD 254 is in the early stages of returning to its natural state relative to its collapsed 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.

[0159]

[0195] FIG. 12E illustrates the completion of the eversion process. The everting membrane 6 has advanced further beyond the acorn-shaped tip 242, fully exposing the IUD 254. At this point, the IUD 254 may be in its natural (i.e., unbiased or mechanically relaxed) state or in a "T" shape. The stem 258 and hormone- or drug-eluting portion 262 are fully exposed from the distal end of the membrane 6. Certain IUDs include a band or ring of copper material as a spermicide. The IUD sutures 252 may still reside within the central lumen of the membrane 6 and the inner catheter (not visible). Once fully exposed outside the membrane 6, the IUD 254 may have reached its insertion depth within the uterine cavity. The insertion depth of the IUD 254 within the uterine cavity may be 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 insertion depth. Additionally, the outer catheter 4 may be configured with a telescoping tube (not shown) that allows for varying the membrane length and insertion depth within the uterine cavity.

[0160]

[0196] 13A-13I show additional derivations for an eversion catheter system 2 for IUD placement. FIG. 13A shows the eversion catheter system 2 with an IUD 254 folded within the eversion membrane 6 (not visible) within the outer catheter 4. The inner catheter 8 can be positioned proximal to the Y-fitting 244 and continue into the outer catheter 4. The eversion membrane 6 can 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 located at the distal end of the outer catheter 4. The eversion membrane 6 can be pressurized with fluid, gas, or a combination thereof via an extension tube and stopcock 248. Within the inner catheter 8 can be a pusher 264, which can be proximal to the inner catheter hub 246. The pusher 264 can be a hollow tube with a pusher hub 266 and can house the IUD sutures 252 within its lumen.

[0161]

[0197] 13B shows the acorn tip 242 in a side view, with a dashed line indicating the through lumen 276 within the acorn tip. The acorn tip 242 can be used to place the everting catheter system 2 into the patient's cervicovaginal canal. The acorn tip 242 includes an intubation tip 268 on its rear surface that can be designed to purchase or intubate the cervical opening with a rounded surface 269 on its front. The acorn tip 242 can have an outer shoulder 270 that provides a stop mechanism to prevent inadvertent insertion of the outer catheter 4 into the patient's cervical canal. The distal opening 272 can be configured to allow the everting membrane to deliver an IUD (both not shown).

[0162]

[0198] 13C and 13D show another type of acorn tip 242. This acorn tip 242 has a thin front surface 274 with an outer shoulder 270 that reduces the front periphery of the acorn tip 242. The thin front surface 274 provides the physician with a wide viewing angle of the cervicovaginal canal when placing an eversion catheter (not shown). By using the thin front surface, the physician can improve visualization of the cervicovaginal canal while maintaining the acorn tip's function for intubating the cervicovaginal canal, providing a firm grip, and also providing a stop mechanism to prevent inadvertent advancement of the outer catheter into the cervical canal. The alternative acorn tip 242 includes an intubation tip 268 at the distal end of its rear surface, which, together with a bevel 271 leading to a shoulder 270, can facilitate initial device placement in the patient's cervicovaginal canal. The dashed line indicates a through lumen 276 with a distal end opening 272.

[0163]

[0199] Returning to the alternative embodiment of the eversion catheter system 2, Figure 13E shows the IUD 254 being advanced by the eversion membrane 6 in response to advancement of the inner catheter 8 into the outer catheter 4 using hydraulic energy supplied to the extension tube and stopcock 248. Along with this, the pusher 264 can be advanced with the eversion membrane 6, with the two IUD sutures 252 exiting the pusher hub 266.

[0164]

[0200] 13F shows the inner catheter 8 translating within the outer catheter 4 as the everting membrane 6 advances the IUD 254 further. The everting membrane everts and pulls the IUD forward, exposing a rounded end 256 distally at the end of the everting membrane 6.

[0165]

[0201] 13G shows the IUD 254 released from the eversing membrane 6, in a fully natural position, i.e., a "T" or "Y" configuration. The IUD sutures 252 can be placed proximal to the IUD and extend through the eversing membrane 6, the pusher 264, and the inner catheter (not visible). To complete the release of the IUD, the pusher 264 advances the IUD 254 past the distal end of the eversing membrane 6.

[0166]

[0202] Figures 13H and 131 show an alternative embodiment of the distal end of the pusher 264. Figure 13H shows the distal end of the pusher 264 with a pusher cup 278 having a concave opening 280 for receiving and retaining the contours of the proximal end of the IUD 254 (not shown). The pusher 264 may have an internal lumen with a central shaft 282. The distal pusher cup 278 facilitates handling and loading of the IUD 254 within an eversion catheter (not shown).

[0167]

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

[0168]

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

[0169]

[0205] 14B and 14C further illustrate the advancement of the IUD 254 within the everting membrane 6 within the everting catheter system 2. The IUD 254 can return to its natural, "T" or "Y" shape when pulled by the everting membrane. FIG. 14B shows the everting membrane 6 pressurized by hydraulic energy. The IUD sutures 252 can be received within split openings 284 within the distal end of the pusher 264.

[0170]

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

[0171]

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

[0172]

[0208] 15B demonstrates the one-handed operation mechanism of the eversion catheter system 2 using the housing 288. The operator's thumb can be placed on the rotating wheel 290, which is 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 the pusher hub 266 is visible emerging from the proximal portion of the housing.

[0173]

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

[0174]

[0210] 15D further illustrates, in a top view, one-handed operation of the everting catheter system 2 as the everting membrane 6 is advanced and the IUD 254 is pulled through the acorn tip 242. The rotating wheel 290 (partially visible under the operator's thumb) can be used to advance the inner catheter 8 and advance the everting membrane. Advancement of the everting membrane 6 can be limited when the inner catheter hub 246 reaches the gear housing 296. As the inner catheter 8 can be advanced into the outer catheter 4, the inner catheter hub 246 reaches the gear housing 296, advancing the pusher 264 until the pusher hub 266 mechanically engages the pusher stop 294. In operation, with the pusher 264 held in place relative to the housing 288 by the pusher stop 294, the operator actuates the outer catheter release button 292, retracting the outer catheter 4 and its attached everting membrane 6. This causes the distal end of the pusher 264 to advance the IUD 254 from the distal end of the eversion membrane 6, releasing the IUD 254 within the uterine cavity. In operation, the operator removes the entire eversion catheter system 2, advancing the IUD sutures 252 from the pusher 264.

[0175]

[0211] 16A-16J show another embodiment of an eversion catheter system 2 with a handle 30. Distal to the handle 600 may be an outer catheter 4 protruding, and proximal to the handle may be a pusher 264 with IUD sutures 252 exiting a pusher hub 266. At the front of the handle 600 may be an inner catheter button 298 and an outer catheter release button 292. At the rear of the handle 600 may be an extension tube and stopcock 248 (partially visible).

[0176]

[0212] 16B shows the inner catheter button 298 advanced within the housing slot 308 on the front of the housing 288. The inner catheter button 298 is attached to the proximal end of the inner catheter (not shown) and, when advanced, causes the inner catheter and eversion membrane to translate, delivering the IUD (not shown). In operation, the inner catheter button 298 advances until it engages the outer catheter release button 292 on the front of the housing 288.

[0177]

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

[0178]

[0214] FIG. 16D provides information regarding how the housing 288 operates in conjunction with the eversion catheter system 2 to advance and release the IUD (not shown). In FIG. 16D, the front of the housing 288 has been removed to reveal the interior of the eversion catheter system 2, including the inner catheter hub 246. Alternatively, the inner catheter hub 246 can be removed with the inner catheter button 298, or both devices can be included as shown. Also visible are the pusher 264 and the pusher hub 266 with the IUD sutures 252 exiting the proximal portion of the pusher hub. The outer catheter release button 292 and inner catheter button 298 are also visible, at which point advancement of the eversion 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 that are designed to fasten the front and rear of housing 288 together.

[0179]

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

[0180]

[0216] 16F shows another cutaway view of the inflation tube slot 300 on the rear face of the housing 288. Within the inflation tube slot 300, the extension tube and plug 248 (plug not shown) are visible.

[0181]

[0217] 16G shows a cutaway of the proximal portion of the housing 288 and the proximal bore 306. A cutaway of the pusher 264 can be seen emerging from the proximal portion of the inner catheter hub 246. On the inner rear surface of the housing 288, the inner channel of the pusher engagement tab 302 can be seen, which narrows as one progresses from the proximal to the distal portion of the housing 288. The pusher hub 266 can have a conical or tapered profile at its distal end to fit within the pusher engagement tab 302. The flat proximal portion of the pusher hub 266 can act as a proximal mechanical detent after the pusher hub 266 extends beyond the pusher engagement tab 302.

[0182]

[0218] 16H shows the initial steps of IUD delivery and placement with another cutaway view of the right side of the housing 288. The outer catheter 4 is distal to the Y fitting 244 and attached to the outer catheter release button 292. Also, an inner catheter button 298 is located in a housing slot 308 on the front of the housing. Extending proximally from the inner catheter 8 and inner catheter button is a pusher 264. Attached to the proximal end of the pusher 264 is a pusher hub 266 with a through lumen for the IUD sutures 252.

[0183]

[0219] FIG. 16I shows the same cutaway view of the extent of advancement of the inner catheter button 298 during the eversion step when the eversion catheter system 2 is hydraulically pressurized via the extension tube and stopcock 248 (stopcock not shown). 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 3 cm to 24 cm, are possible. Furthermore, the insertion depth can be controlled by the physician by stopping the eversion step at any point during the process.

[0184]

[0220] 16J illustrates the release step of the IUD delivery process using the everting catheter system 2. The outer catheter release button 292 is retracted, threading the pusher 264 onto the inner catheter 8 and advancing the IUD (not shown) through the everting membrane (not shown).

[0185]

[0221] 17A-17I illustrate another embodiment of an eversion catheter for delivering an IUD. FIG. 17A illustrates an eversion catheter system 2 with a housing 288, with a pusher 264 and a pusher hub 310 extending proximally relative to the housing. The pusher hub 310 is configured to receive a syringe 74 or other irrigation source to provide fluid, saline, contrast, ultrasound medium, drug or therapeutic agent, or gas or air through the central lumen of the eversion catheter system 2. The irrigation fluid or medium can facilitate visual identification of the cervico-vaginal or uterine cavity by ultrasound or fluoroscopy.

[0186]

[0222] 17B shows the eversion catheter system 2 at an early stage in the eversion process, with the front of the housing 288 removed to reveal the internal parts and mechanisms.

[0187]

[0223] 17C shows the everting catheter system 2 with hydraulic energy supplied via the extension tube and stopcock 248. The inner catheter button 298 is advanced to translate the inner catheter 8 within the outer catheter 4. The everting membrane 6 extends distally relative to the acorn tip 242, pulling 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 in the housing 288 and into the path of the pusher engagement tab 302.

[0188]

[0224] 17D shows the next step in the eversion process: the inner catheter button 298 engages the outer catheter release button 292 and the pusher hub 310 reaches the mechanical detent of the pusher engagement tab 302.

[0189]

[0225] 17E shows the next step in the IUD delivery process: syringe 74 is connected to extension tubing and stopcock 248 to draw negative pressure within eversion catheter system 2. The negative pressure draws hydraulic energy within eversion membrane 6.

[0190]

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

[0191]

[0227] 17G shows a close-up of the distal end of the everting membrane 6. The hydraulic energy has been removed from the everting catheter system 2, and the distal end of the pusher 264 extends beyond the distal opening in the 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.

[0192]

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

[0193]

[0229] FIG. 17I shows the syringe 74 with the engagement button 312 released, causing the plunger spring 314 to expand and the plunger 76 to retract, creating a negative pressure within the syringe 74 and eversion catheter system 2 (not shown).

[0194]

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

[0195]

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

[0196]

[0232] 18C illustrates the next step in the IUD delivery and placement process. Pressing the outer catheter release button 292 causes the engagement button 312 to release the plunger spring 314 and plunger 76, creating negative pressure within the everting catheter system 2 via the inflation tube 318. At this point, the outer catheter release button can be retracted along the housing slot 308, retracting the outer catheter 4, everting membrane, and inner catheter (not shown), while maintaining the position of the pusher (not shown) and releasing the IUD from the everting membrane (both not shown).

[0197]

[0233] FIG. 19A shows an eversion catheter system 2 for delivering an IUD in an inverted state. The IUD 254 can be loaded in a folded state into the balloon membrane (not visible) and inner catheter 8. The inner catheter 8 can be placed within the 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 is a T-fitting 244 for eversion balloon pressurization with an X-ring valve (not shown) for translation of the inner catheter 8. The inner catheter 8 has a proximal hub 246, which can be a luer connector, knob, or handle for manipulating the inner catheter. Within the central lumen of the inner catheter 8 is a pusher 264 with a lumen for one or more IUD sutures 252. Pressurization of the eversion catheter system 2 can be performed by a syringe 410 and syringe plunger 409. The syringe 410 and syringe plunger 409 can be connected to a connector 413 by the user or physician. Connector 413 may be connected to flexible tubing 412. Pinch clamp 411 may be used by a user or physician to close flexible tubing 412 and maintain pressure within the eversion balloon. After pressurization, syringe 410 may be detached and removed from eversion catheter system 2 prior to insertion into a patient.

[0198]

[0234] 19B-19D are enlarged views of various portions of the everting catheter system 2. FIG. 19B is an enlarged view of the distal end of the outer catheter 4, showing the initial portion of the everting balloon 6 extending from the distal end of the outer catheter 4. The distal opening of the outer catheter 4 may have an acorn-shaped tip or may have a smooth, rounded, low-profile distal tip instead of an acorn-shaped tip. The distal end may have indicia 402, e.g., 7 cm, 8 cm, 9 cm, and 10 cm markings, to provide insertion depth guidance to the user (e.g., physician). A movable flange 401 may be positioned by the user (e.g., physician) to provide visual and tactile insertion depth indicators. Within the outer catheter 4, the everting balloon and the IUD 254 in its folded, loaded, low-profile state within the inner catheter (not visible) are visible.

[0199]

[0235] FIG. 19C is an expanded view of a pressurization system for the eversion catheter system 2. Pressurization of the eversion catheter 2 can be performed by a syringe 410 filled with saline, sterile water, air, an inert gas, or a combination of gas and fluid medium. When a user or physician presses the syringe plunger 409, hydraulic energy is delivered to the eversion balloon. The 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 possible. Pressurization of the eversion catheter system 2 can expand the flexible tube 412. The flexible tube 412 can be made from silicone and / or other elastomeric materials, such as polyurethane, rubber, and TPE, or a combination thereof. The flexible tube 412 can maintain a nearly constant pressure within the eversion catheter system 2 during eversion and eversion. Because the silicone tube can continue to expand in response to the addition of hydraulic pressure, the flexible tube 412 can mitigate against a user or physician inadvertently applying excessive pressure within the eversion catheter system 2. The amount of pressure applied can range from 1 to 4 atmospheres, with a nominal level of 2 atmospheres. The amount of compliance within the silicone tubing can depend on the durometer of the material, the wall thickness of the tubing, and the length of tubing available for expansion. For example, as shown, the flexible tubing 412 can be silicone with a durometer of 50A, a length of 6 cm, an outer diameter of 4.75 mm, and a wall thickness of 1 mm. The pressure application system can be closed by the user using a pinch clamp 411 to close the lumen of the flexible tubing 412 after pressurization, such as with a syringe 410. Other tube closure devices, such as a stopcock, gate valve, roller clamp, or combinations thereof, can also be used. Instead of or in combination with the connector 413, a one-way check valve or Luer-activated valve can be placed on the flexible tubing 412 to allow one-way pressurization, eliminating the need for the user to activate a closure device to close and maintain pressure within the flexible tubing 412 and eversion catheter system 2.Water pressure provided by syringe 410 and syringe plunger 409 can be fluidly connected to eversion catheter system 2 through t-fitting 244 with an x-ring valve (not shown) to maintain pressure during eversion of the balloon membrane and translation of inner catheter 8 within outer catheter 4. Inner catheter 8 can 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, where it has an outer diameter of 4 mm and an inner diameter of 3 mm.

[0200]

[0236] FIG. 19D shows an enlarged view of the proximal portion of the eversion catheter system 2, illustrating the inner catheter 8 with the proximal connector hub 246 having a central through-hole. Within this central through-hole can reside a pusher 264 with a pusher hub 266 having a central through-hole through which the IUD sutures 252 pass. The proximal connector hub 246 and the pusher hub 266 can be luer connectors, allowing connection of a syringe or tubing for injecting a fluid, saline, or gas medium to distend the uterine cavity for ultrasound, fluoroscopy, or endoscopic visualization. The proximal connector hub 246 and the pusher hub 266 can be handles or knobs for a user or physician to manipulate the catheter. The pusher 264 can be made of nylon, Pebax, polypropylene, polyethylene, or a combination 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 approximating the entire length of the eversion catheter system 2, for example, to allow a user or physician to expel the IUD from the inner catheter 8 during placement within the uterine cavity.

[0201]

[0237] FIG. 20A shows the eversion catheter system 2 after the balloon has been fully everted during the IUD delivery process. The IUD 254 may be in a collapsed, loaded state within the inner catheter 8 and eversion balloon 6. The outer catheter 4 may include indicator marks 402 and an insertion depth marker flange 401. The outer catheter 4 may be connected to a t-fitting 244 with an x-ring valve (not shown) and to flexible tubing 412 with a luer connector 413 and tubing pinch clamp 411 for hydraulic pressurization of the eversion catheter system 2. Immediately proximal to the t-fitting 244 may be a proximal connector hub 248, indicating full eversion of the eversion balloon and full translation of the inner catheter (not visible). Proximal to the proximal connector hub 248 are a pusher 264 and a pusher hub 266. Proximal to the pusher hub 266, the IUD sutures 252 can be seen extending beyond the central lumen of the tubing.

[0202]

[0238] FIG. 20B is a close-up view of the distal end of the eversion catheter system 2 with the fully everted balloon 6 and IUD 254. The distal end of the inner catheter (not visible) can be connected to the eversion balloon 6, and the rounded distal end 256 of the IUD 254 can be immediately distal to the fully everted balloon 6. Portions of the IUD 254 are visible through the eversion balloon 6 and inner catheter, including the copper wire 271, IUD axial bore 272, suture knot 273, and IUD sutures (not visible). The eversion balloon 6 can be connected to the outer catheter 4, which has indicator marks 402. For example, the eversion balloon 6 can be 6 cm long to traverse the length of the cervix and 3.5 cm long from the cervix to the internal cervical os. Different lengths of the eversion balloon 6 can be used to approximate the uterine lengths of various patients. The eversion balloon may have, for example, an outer diameter of 4 mm at 2 atmospheres of pressure and a wall thickness of 0.0015 thousands of an inch. The eversion balloon may be made from irradiated polyolefin, polyethylene, Pebax, polyurethane, other biocompatible materials capable of producing a hydrostatic eversion balloon, or combinations thereof.

[0203]

[0239] The distal end of the inner catheter (not visible) may have an inner diameter that allows the collapsed IUD to fit within the tube, for example. For example, a 3 mm inner diameter allows the collapsed IUD to fit within the tube, while the blunt distal end 256 remains protruding distally relative to the inner catheter (not visible) and eversion balloon 6. The distal end of the pusher (not visible) may be immediately proximal to the IUD axial bore 272 and suture knot 273. The distal end opening of the eversion balloon 6 may be connected to the distal end of the inner catheter (not visible). When everted and pressurized, the eversion balloon 6 may collapse the IUD 254 into a low-profile state to aid in advancement through the cervical canal and into the uterine cavity. When everted and pressurized, the eversion balloon 6 may also collapse and compress the blunt distal end 256 into a low-profile state for advancement through the eversion catheter system 2, the distal end opening of the outer catheter 4, and the cervical canal into the uterine cavity, for example.

[0204]

[0240] 20C is a close-up view of the proximal portion of the eversion catheter system 2 after full eversion in the process of delivering the 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 flexible tubing 412. The tubing pinch clamp 411 is shown in a closed state, and hydraulic pressure is applied within the eversion catheter system 2. The proximal connector hub 248 is immediately proximal to the t-fitting 244, allowing for, for example, full eversion of the eversion balloon (not shown) and full translation of the inner catheter (not visible). Within the proximal connector hub 248 is a pusher 264 with a pusher hub 266 at its proximal end, and the IUD sutures 252 can be seen extending through the central lumen of the pusher 264.

[0205]

[0241] 21A-21C illustrate the process of delivering an IUD into a simulated uterine cavity model 500 (which, for illustrative purposes, represents a patient's uterine cavity and other anatomical structures) using a metric ruler 510 for reference. FIG. 21A illustrates placement of an IUD 254 within the simulated uterine cavity model 500. The model 500 has a fundus 501 simulating the cranial apex of the uterine cavity, and cornual regions 502 (representing the patient's right tubal ostium) and 503 (representing the patient's left tubal ostium). The simulated uterine cavity model may include a lower uterine segment 504 having a simulated cervix 505 and a simulated cervicovaginal region 506. The eversion balloon 6 of the eversion catheter system 2 may be fully everted, with the blunt distal end 256 of the IUD 254 proximal to and distal to the fundus 501 of the uterine cavity. The pusher 264 can be proximal to the IUD 254. The flange 401 abuts the cervico-vaginal cavity 506, and the insertion depth can be, for example, about 9 cm.

[0206]

[0242] 21B illustrates the next (e.g., intermediate) step in the IUD placement process using the everting catheter system 2. At this point, the everting catheter system 2 can be retracted 1.5 cm, as indicated by the flange 401 being at a distance of, for example, 1.5 cm from the cervico-vaginal cavity 506. With this, the IUD 254 can be expelled from the distal end of the everting balloon 6 by retraction of the pusher 264 and everting catheter system 2. The rounded distal end 256 of the IUD 254 can extend outward toward the corner regions 502 and 503.

[0207]

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

[0208]

[0244] 22A through 22E show a packaging configuration for shipping and loading an eversion catheter system 2 for IUD delivery. The eversion catheter system 2 can be placed on a pouch card 600 in a fully everted position, with the IUD 254 resting on the distal end of the eversion balloon (not visible). The pouch card 600 and eversion catheter system 2 can be placed in a sealed pouch (not shown) for sterilization, shipping, and eventual use by the physician. The pouch card 600 can be made from clear laminated cardboard, PETG, polypropylene, polyvinyl chloride, PET, or a combination thereof. Attached to the pouch card 600 can be a protective tube 601, which can be, for example, 6.5 cm long and have an inner diameter of 4 mm. The length of the protective tube 601 can be set to cover the fully everted balloon (not visible) while maintaining the IUD 254 in an open configuration so that the rounded distal end 256 extends beyond the distal end of the protective tube 601. The inner diameter of the protective tube 601 can be sized to allow the unpressurized eversion balloon (not visible) to slide through the central lumen. When the eversion balloon (not visible) is pressurized, the outer diameter of the eversion balloon can contact the lumen of the protective tube 601. Contact with the lumen when pressurized allows the eversion balloon and inner catheter to be easily retracted, for example, by a 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) can be held in place by the pouch tab 602. The pusher 264, pusher hub 266, and IUD suture 252 can extend proximally relative to the eversion catheter system 2.

[0209]

[0245] 22B is a close-up view of the distal portion of the pouch card 600 and a modified protective tube 601 with the eversion 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 eversion catheter system 2, with the IUD sutures (not visible in this view) extending the entire length of the inner catheter and pusher of the eversion catheter system 2. The proximal end of the protective tube 601 can be intubated into the distal end of the outer catheter 4.

[0210]

[0246] 22C illustrates steps in preparation (e.g., unpackaging, assembly, and pressurization) of eversion catheter system 2. Pouch 603 can be peeled partway open 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 tubing can be rotated upward, i.e., perpendicular to the surface or pouch card 600. The eversion catheter system can be pressurized with 3 cc of saline.

[0211]

[0247] 22D shows that with the syringe detached and removed from the luer connector 413, the flexible tubing 412 can be in a closed position, pressurized by the pinch clamp 411. The IUD sutures 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.

[0212]

[0248] 22E is a close-up view of the distal portion of the pouch card 600, in which the IUD 254 may be in a folded loaded configuration within the inner catheter (not visible) within the protective tube 601. The eversion balloon (not visible) may then be fully inverted with the inner catheter (not visible) fully translated back to remove the eversion catheter system 2 from the protective tube 601 and pouch 603, for example, in preparation for insertion into a patient.

[0213]

[0249] Any element described herein as singular can be plural (i.e., anything described as "one" can be more than one). Any species element of a genus element can 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 (e.g., liquid, gas, 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 individual figures. The above-described configurations, elements, or complete assemblies, and methods for implementing the present disclosure and variations of aspects of the disclosure, and their elements, can be combined and modified with each other in any combination. All devices, apparatus, systems, and methods described herein can be used for medical (e.g., diagnostic, therapeutic, or rehabilitative) or non-medical purposes.

[0250]

[0214]

[0251] U.S. Patent No. 9,028,401, filed May 12, 2015, U.S. Patent No. 9,101,391, filed August 11, 2015, U.S. Patent No. 10,034,986, filed July 31, 2018, U.S. Patent No. 2019 / 0009058, published January 10, 2019, U.S. Patent No. 2020 / 0206463, published July 2, 2020, U.S. Patent No. 202 / 0297384, published September 24, 2020, and U.S. Patent No. 2020 / 0023162, published January 23, 2020, are all incorporated herein by reference in their entireties.

[0215]

[0252] Any element described herein as singular can be plural (i.e., anything described as "one" can be more than one). Any species of a genus can have features or elements of any other species of that genus. As used herein, "dilation" and "dilatation" are used interchangeably. The medium 155 delivered herein can be any of the fluids described herein (e.g., liquid, gas, 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 individual figures. The above-described configurations, elements, or complete assemblies, and methods for implementing the present disclosure and variations of aspects of the disclosure, and their elements, can be combined and modified with each other in any combination. All devices, apparatus, systems, and methods described herein can be used for medical (e.g., diagnostic, therapeutic, or rehabilitative) or non-medical purposes.

Claims

1. 1. A system for delivering a device into the female reproductive tract, comprising: a first catheter having a lumen and a distal lumen port, the first catheter having a retracted configuration and an extended configuration; an eversion balloon attached to the first catheter, at least a length of the eversion balloon extending past a distal end of the first catheter when the first catheter is in the extended configuration, the length of the eversion balloon extending past the distal end of the first catheter when the first catheter is in the extended configuration including a check valve; a second catheter slidably disposed within the first catheter; an IUD within the second catheter; and A system comprising:

2. 1. A system for delivering a device into the female reproductive tract, comprising: a first catheter having a lumen and a distal lumen port, the first catheter having a retracted configuration and an extended configuration; an eversion balloon attached to the first catheter, at least a length of the eversion balloon extending past the distal end of the first catheter when the first catheter is in the extended configuration; and a second catheter slidably disposed within the first catheter; an IUD within the second catheter; and a distal closure tip attached to the eversion balloon; wherein the distal closure tip includes a pressure relief element.

3. The system of claim 1 , wherein the distal closure tip is configured to detach the eversion balloon from the first catheter and the second catheter.

4. 1. A system for delivering a device into the female reproductive tract, comprising: a first catheter having a lumen and a distal lumen port, the first catheter having a retracted configuration and an extended configuration; an eversion balloon attached to the first catheter, at least a length of the eversion balloon extending past the distal end of the first catheter when the first catheter is in the extended configuration; and a second catheter slidably disposed within the first catheter; an IUD within the second catheter; and a third catheter radially outward of the first catheter; A system comprising:

5. 5. The system of claim 1, wherein the everting balloon is attached to the third balloon at a first end of the everting balloon and the everting balloon is attached to the first catheter at a second end of the everting balloon.

6. 1. A system for delivering a device into the female reproductive tract, comprising: a first catheter having a lumen and a distal lumen port, the first catheter having a retracted configuration and an extended configuration; an eversion balloon attached to the first catheter, at least a length of the eversion balloon extending past the distal end of the first catheter when the first catheter is in the extended configuration; and a second catheter slidably disposed within the first catheter; an IUD, wherein the second catheter is configured to deliver the IUD. system.

7. 1. A method for performing IUD placement in a uterine cavity, comprising: Positioning an eversion balloon system adjacent to the cervical canal, said eversion balloon system comprising: a first catheter having a catheter lumen and a distal port at a distal end of the catheter lumen; an eversion balloon attached to the first catheter; a delivery catheter attached to an end of the eversion balloon opposite the first catheter; positioning an eversion balloon system, and everting the eversion balloon in the cervical canal, wherein the everting comprises pulling the first catheter distally through the cervical canal, the first catheter having an IUD device, and wherein the everting comprises inflating the balloon distal to the first catheter.

8. 8. The method of claim 1, further comprising deploying the IUD into the uterine cavity simultaneously with everting the eversion balloon, wherein the deploying comprises releasing the IUD using a pusher.

9. 9. The method of any one of claims 1 to 8, wherein deployment of the IUD device occurs after extension of the eversion balloon during the eversion process.

10. 10. The method of any one of claims 1 to 9, wherein placement of the IUD device is performed using negative pressure from a suction source.

11. 1. A method for performing an IUD delivery and placement procedure in a uterine cavity, comprising: Positioning an eversion balloon system at the cervico-vaginal opening of the cervix, said eversion balloon system comprising: a first catheter having a catheter lumen and a distal port at the distal end of the catheter lumen; an eversion balloon attached to the first catheter; an outer catheter attached to an end of the eversion balloon opposite the first catheter; positioning an eversion balloon system, abducting the eversion balloon in the cervical canal, wherein the everting comprises pulling the first catheter distally through the cervical canal, the first catheter having an IUD, the IUD in a first configuration within the eversion membrane, the IUD having a second configuration when the IUD extends beyond the eversion membrane, and the IUD having a larger surface area when in the second configuration than when in the first configuration.

12. 12. The method of any one of claims 1 to 11, comprising releasing the IUD in combination with delivering negative pressure into the eversion balloon.

13. 13. The method of any one of claims 1 to 12, wherein a pusher in combination with negative pressure in the eversion balloon stretches the IUD as it is released.

14. 14. The method of any one of claims 1 to 13, wherein the pusher is used for perfusion medium during the IUD delivery and placement procedure.

15. 1. A method for delivering and placing an IUD into a uterine cavity, comprising: Positioning an eversion balloon system at the cervico-vaginal opening of the cervix, said eversion balloon system comprising: a first catheter having a catheter lumen and a distal port at the distal end of the catheter lumen; an eversion balloon attached to the first catheter; an outer catheter attached to an end of the eversion balloon opposite the first catheter; positioning an eversion balloon system, abducting the eversion balloon in the cervical canal, the eversion comprising pulling the first catheter distally through the cervical canal, the first catheter having an IUD in a folded state within the eversion balloon.

16. 16. The method of any one of claims 1 to 15, further comprising collecting tissue with a fixed biopsy device at a specific location within the patient's body due to the location of the membrane on the outer surface of the eversion membrane.

17. 1. A system for delivering and placing an IUD in a female reproductive tract, comprising: a first catheter having a lumen and a distal lumen port, the first catheter having a retracted configuration and an extended configuration; Pusher and an eversion balloon attached to the first catheter by a pusher, the eversion balloon configured such that at least a length of the eversion balloon extends past the distal end of the first catheter when the first catheter is in the extended configuration; and a second catheter secured within the first catheter; and an IUD, wherein the second catheter is configured to accommodate the IUD and release the IUD when the first catheter and the pusher extend beyond the eversion balloon.

18. 18. The system of any one of claims 1 to 17, further comprising a suction source configured to be activated when the outer catheter is retracted after stretching the eversion balloon in a female reproductive organ.

19. 1. A method for delivering a substance into a uterine cavity, comprising: everting a balloon within the cervical canal, the balloon being attached to a first catheter, and everting comprising pulling the first catheter distally through the cervical canal; delivering an IUD into the uterine cavity via the first catheter; occluding the cervical canal with the balloon after delivery of the IUD, including occluding with the eversion balloon; A method comprising:

20. 20. The method of any one of claims 1 to 19, further comprising removing the eversion balloon from the cervical canal.

21. 21. The method of any one of claims 1 to 20, further comprising inflating the balloon distal to the first catheter.

22. 22. The method of any one of claims 1 to 21, further comprising fluid-sealing a distal port of the first catheter to the uterine cavity.

23. 23. The method of any one of claims 1 to 22, wherein the occluding comprises sealing the IUD against movement into the cervical canal.

24. 24. The method of any one of claims 1 to 23, wherein the sealing comprises forming a check valve comprising at least a portion of the balloon distal to the first catheter.

25. 1. A system for delivering a substance into the female reproductive tract, comprising: a first catheter having a lumen and a distal lumen port, the first catheter having a retracted configuration and an extended configuration; an eversion balloon attached to the first catheter, at least a length of the eversion balloon extending past the distal end of the first catheter when the first catheter is in the extended configuration; and a second catheter slidably disposed within the first catheter; IUD material within the second catheter; and a handle configured to control eversion of the eversion balloon, the handle configured to control translation of the second catheter; A system comprising:

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