Apparatus and method for an intussusceptible catheter for delivering and placing an IUD in the uterine cavity

Abstract

Disclosed is an externally protruding balloon system that can be used to place an IUD within the uterine cavity of a female patient. The externally protruding balloon system with an IUD can be used to access a specific location in the uterine fundus. Disclosed is a one-handed IUD delivery system for placement within an externally protruding catheter. Disclosed is an IUD loading system for placement within an externally protruding catheter. The externally protruding catheter with an IUD can simplify the process of placing an IUD within the uterine cavity.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 913,160, filed on October 9, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The devices and methods disclosed herein can be used for an external eversion catheter, characterized by having an inner catheter, an outer catheter, and an external eversion membrane that can be connected to the two catheters. The inner catheter can contain an inner lumen to allow fluid or media, drugs or therapeutic agents, instruments or devices (such as intrauterine devices (IUDs), endoscopes, and other catheters) to pass through. Background Art

[0004] For doctors and medical professionals, systems for accessing patient vessels and body cavities typically use various guidewire and catheter technologies. In some cases, the process requires inserting a series of mandrels or wires to increase the diameter of the lumen so that larger-caliber instruments can ultimately pass through the vessel. This technique may be called "Dottering," or in the case of accessing the cervical canal and uterus, the doctor will use a series of mandrels with increasing diameters known as Hegar dilators. In the above-mentioned techniques, these methods involve pushing an object, mandrel, or device through a blood vessel to access the desired area in the body. The result of pushing the object, mandrel, or device generates shear forces on the lumen wall. In some cases, the shear forces may cause trauma, pain to the patient, or perforation.

[0005] In contrast, another access technique that has been used in the prior art is referred to as an everting catheter. An everting catheter utilizes a traversing action in which the balloon is inverted and, under the influence of the hydraulic pressure generated by a compressible or incompressible fluid or medium, is rolled or passed through the blood vessel from the inside out by a propulsive force. An everting balloon is referred to as a rolling or external rolling balloon, an everting membrane, an external endoscope catheter, or a linear everting catheter, such as those in U.S. Patents 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 they are used to pass through a vascular vessel, cavity, tube, or tubular organ in a frictionless manner. In other words, the eversion balloon can be passed through the tube without applying any shearing forces to the wall being passed through. Because this action is free of shearing forces, it can reduce trauma and lower the risk of perforation. Furthermore, due to the mechanism of passage through the vessel, materials and substances in the proximal portion of the tube or vessel are pushed or propelled forward to the more distal portion of the tube or vessel.

[0006] Furthermore, when the everted catheter deploys from the inside out, uncontaminated or untouched balloon material is placed within the vessel wall. In the inverted or undeployed state, the balloon and IUD reside within the catheter body and do not come into contact with the patient or physician. When the balloon is pressurized and inverted, the balloon material rolls from the inside out, avoiding contact with any components at the external access point of the vessel. During IUD delivery, this inside-out rolling action also prevents the IUD from contacting the vaginal wall, the external cervical canal, any tissue within the cervical canal, and, depending on the insertion depth, the patient's internal cervical os. Another advantage of the everted balloon catheter is a more comfortable entry method for the patient, as hydraulic pressure "pulls" the balloon membrane through the vessel or catheter, whereas standard catheters require "pushing" the balloon membrane and IUD through the cervix and into the uterine cavity, whereas standard IUD catheters require "pushing" the balloon membrane and IUD through the cervix and into the uterine cavity.

[0007] To gain access to the uterine cavity for larger devices, doctors typically use a method of accessing a woman's cervical canal that requires the use of multiple instruments of increasing diameter. Doctors will initially gain access to the uterus through the cervix using a small hysterosalplasty or small-diameter probe or Hegar device. Increasingly larger Hegars are used to stretch the cervical muscles until the desired internal diameter is reached to facilitate the insertion of auxiliary instruments, such as an endoscope or other devices. This procedure can be particularly difficult for some nulliparous women seeking to use an IUD for contraception or who choose to use a hormonal IUD to relieve abnormal bleeding. Postmenopausal women may also have a very small diameter cervical canal. Passing through the cervix may be difficult due to previous surgery, underlying strictures, or other anatomy or tortuosity that makes passage of instruments or Hegar dilators difficult.

[0008] Several cervical dilators exist that provide radial dilation to open the cervical canal to a larger internal diameter without inserting multiple instruments. All of these devices rely on first crossing or traversing the cervical canal before the radial dilation step. Once through the cervical canal, these devices dilate using either a mechanical mechanism or a balloon dilation member concentric with the exterior of the dilator probe. If the cervical canal is particularly tight or narrow, a smaller diameter probe or mandrel may be required to initially cross the cervix and into the uterine cavity. As the diameter of the mandrel or instrument becomes smaller, the likelihood of perforation or mis-passage increases. In any case, these cervical dilators require an initial probe passage or crossing before any further radial dilation can be performed.

[0009] The eversion catheter has been described as a dilation catheter. Representative examples of dilation eversion catheters include US Pat. Nos. 5,364,345 and 4,863,440, both of which are incorporated herein by reference in their entirety.

[0010] Outward-turning catheters have also been described as having additional elements, such as handles for controlling the instruments in the outward-turning catheter. Representative examples are U.S. Patent No. 5,346,498, which is incorporated herein by reference. Outward-turning balloon catheters can be made of an inner catheter with a lumen or a through-lumen. Through-lumen can be used to pass instruments, media, materials, therapeutic agents, endoscopes, guidewires or other instruments or devices. Representative samples of outward-turning catheters with through-lumen are in U.S. Patents No. 5,374,247 and 5,458,573. In addition, outward-turning catheters with waist or balloon diameter narrowing have been described, such as described in U.S. Patent No. 5,074,845, which is incorporated herein by reference in its entirety.

[0011] An everted catheter is particularly useful for accessing the uterine cavity, where the cervical canal may be narrow, tortuous, or contain cesarean scars or other anatomical structures that make it difficult for the physician to pass the instrument. This, in turn, can make the procedure uncomfortable for the patient.

[0012] A common gynecological procedure for women seeking a non-permanent method of birth control is the insertion of an IUD (Intrauterine Device) or an intrauterine device that delivers medications for abnormal uterine bleeding, hormonal therapy for dysmenorrhea, or other medications placed within the uterine cavity via an implant. IUDs can contain copper and come in a variety of configurations. In all cases, a doctor will need to place the device within the uterine cavity.

[0013] To place the IUD in the uterus, the IUD inserter consists of a fairly stiff tube or cannula for insertion. The IUD implant itself can be constructed in its natural, unfolded state into a "T-shape" or "Y-shape," where the three arms of the "T" or "Y" are constructed as rigid members that can bend but not easily bend within a narrow radius of less than .500." The "T" or "Y" configuration is required to maintain the IUD within the uterine cavity during normal female activities as well as other more vigorous activities such as exercise, coughing, and uterine contractions that occur during menstruation. In these cases, the "T" or "Y" shape is required to prevent expulsion or migration from the uterine cavity because the arms of the "T" or "Y" are intended to maintain the IUD near the patient's fundus with their rounded ends that approach the bilateral corners of the uterine cavity. Not all IUDs are "T" or "Y" shaped, and other configurations, including circular or spiral shapes, are known or commercially available.

[0014] During clinical use during device placement, the endocervical lining can have numerous bends and curvatures, including tight radius curves. To facilitate placement through the cervical canal and straighten the endocervical lining to reduce the amount of curvature, the physician needs to grasp the cervix and maintain cervical traction. In addition to straightening the cervix, this traction also helps push the IUD inserter through the endocervical lining and into the uterine cavity. Misplacement, perforation, or failure to insert the IUD are all known and recognized outcomes or adverse events of the IUD insertion process. The rigidity of the cannula and the IUD implant itself can also cause discomfort during placement. This is particularly true for women with a narrow cervix or those who are nulliparous.

[0015] Once the IUD is in place within the patient, the IUD inserter may have a cannula attached to a handle that allows the physician to remove the IUD from the distal end of the cannula. The handle allows the physician to perform the insertion procedure with one hand.

[0016] After the IUD is placed in the uterine cavity, the IUD inserter is removed from the patient. As the inserter is slid out of the cervix, the IUD's removal suture or sutures remain in the patient's cervical canal. Once removed, the physician can trim the visible sutures extending from the exocervix. The IUD sutures are visible in the patient's vagina, extending from the exocervix, and can be trimmed according to the IUD manufacturer's labeling.

[0017] Furthermore, when delivering an IUD, device, apparatus, and reproductive material (e.g., embryo) into the uterine cavity, the access system may push cervical mucus or fluids and materials from the vagina into the uterine cavity. These fluids and materials from the vagina may promote bacterial infection. The balloon deployment action is designed to minimize this effect.

[0018] In addition, the access system of the uterine cavity may produce a vacuum effect when the access system is retracted or removed from the uterine cavity. In the case of embryo transplantation, this vacuum effect may accidentally move reproductive material out of the uterine cavity. In existing systems, when the transfer catheter is retracted from the second outer catheter or guide catheter (for example, "inner" catheter), this retraction can produce vacuum pressure in the uterine cavity. This vacuum pressure is produced in the uterine cavity by removing and moving backward the transfer catheter in the inner catheter. After embryo transplantation is completed, the embryologist can check the transfer catheter to verify that embryo or reproductive material are really deposited in the uterus and are not pulled back to the transfer catheter because of the vacuum effect. Once the catheter is removed, the external catheter can be performed the same process. For the placement of IUD, having a system that can potentially reduce the vacuum effect can cause more reliable and accurate IUD placement.

[0019] In addition, the term "extrovagination balloon" describes the action of a balloon being inverted and rolling or everting from the inside out under the influence of the hydraulic pressure generated by a compressible or incompressible fluid or medium. Extrovagination balloons are also known as rolling or outward-rolling balloons, extrovagination membranes, topological catheters, or linear extrovagination balloons. Due to their characteristic of passing through a vessel, cavity, tube, or catheter in a substantially frictionless manner, they are classified as extrovagination balloons. Extrovagination balloons can pass through a tube without applying any significant shear force to the wall being passed through. Since this action is free of shear force, materials and substances in the proximal portion of the tube or vessel are pushed forward or propelled to the more distal portion of the tube or vessel. For example, for an extrovagination balloon in the female reproductive tract, during insertion or catheter preparation, potentially infectious materials from the vagina, cervical os or exocervix, or the patient's legs or other anatomical structures, as well as the physician's hands, will not come into contact with the extrovagination balloon located in the catheter system before deployment on the patient. The purpose of keeping the extrovagination balloon isolated from potentially unclean surfaces is to reduce postoperative infections. Summary of the Invention

[0020] A balloon system is disclosed. The balloon system can be used for IUD placement, delivery of instruments, devices, and endoscopes, as well as for insemination, enuresis, dilation of body cavities, accessing and sealing body cavities, or combinations thereof. The system can have automated deployment and detachment. The system can have a handle for insertion. The system can have a powered air or fluid pump or pressurization source. The system can have an inner and outer catheter that can automatically detach during eversion.

[0021] The eversion balloon system can have a cannula base with a locking balloon that can be activated when pressurized. The system can be a compact, low-profile unit for use in vivo. The system can be disposable and disposable. The system can be non-irritating and non-infectious.

[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 enables a user to perform a one-handed operation technique. The one-handed operation technique can include advancing and pressurizing the eversion balloon membrane with one hand within the user's control.

[0023] The everting 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 deposit the drug or sperm and allow patient mobility. The everting balloon system can have a decoupling mechanism configured to decouple the outer and inner catheters while maintaining hydraulic pressure in the everting balloon. The system can simultaneously deflate and remove the everting balloon.

[0024] The system can be used to place or deliver a tubal insert (i.e., an intratubular insert, such as the Essure device from Bayer Corporation) into the fallopian tube. The system can access the intramural and isthmic portions of the fallopian tube. All or part of the eversion catheter system can be incorporated into a hysteroscope and placed under direct endoscopic visualization.

[0025] The eversion catheter system can be a selective fallopian tube catheter with a curved distal portion and an angled bulb. This configuration can be performed using ultrasound or radiographic visualization.

[0026] One or more fallopian tube closure devices (e.g., Essure device) can be loaded into the outward-turning balloon system, e.g., in the through-cavity of the inner catheter. Once completely outward-turning and placed in the fallopian tube, the outward-turning balloon system, e.g., the inner catheter, can be taken out from the fallopian tube while the fallopian tube closure device is left in the fallopian tube. Once the outward-turning balloon system is retracted from the fallopian tube, the closed fallopian tube (e.g., a device anchor such as a coil can be stretched, or an elastic porous matrix can be expanded to frictionally fit the lumen) can be expanded. Once the fallopian tube closure device has been deployed, the central guidewire can be removed from the fallopian tube. This process can be repeated for the contralateral fallopian tube.

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

[0028] Also disclosed herein are specialized external catheter systems with specific instruments, tools, or functions constructed or placed within the external catheter system. Examples of such tools or instruments include biopsy devices, cytology devices, drug delivery mechanisms, fluid delivery mechanisms, endoscopes, IUDs, or other instruments to be delivered to a body cavity, body space, potential body space, or body vessel created by the external balloon mechanism. There are several advantages to having an IUD built into or placed within the external catheter system as a delivery mechanism. The external balloon can be used to pull the IUD implant into the uterine cavity without requiring the physician or operator to push an inserter through the cervical canal and into the uterine cavity. This is particularly useful for a curved or constricted cervix. Furthermore, the external balloon rolls through the passageway from the inside out in a frictionless manner without exerting shear forces on the lumen walls. The external balloon serves to protect the body passageway from the distal contour of the IUD while the IUD is being pulled into the desired position.

[0029] The IUD can be secured to the eversion catheter system and automatically expands 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 is isolated from body tissue until it expands beyond the distal end of the eversion balloon. During this process, the IUD does not come into contact with the vagina, the endocervix, or other fluids, mucus, or tissue in the proximal region of the endocervix. Positioning the IUD at a specific distance within the eversion catheter system can provide the physician with the ability to precisely guide the IUD to a specific location within the endocervix or uterine cavity.

[0030] The IUD placement procedure may be performed or delivered at a specific location in the uterine cavity.

[0031] The eversion membrane used for IUD insertion can be designed for one-handed insertion.

[0032] The eversion membrane used for IUD insertion can be designed for one-handed insertion, with automatic negative pressure during IUD release.

[0033] The everted membrane used for IUD placement can be designed for one-handed placement by automatically or manually flushing through the central lumen during IUD release. Automatic flushing can facilitate device placement by releasing the IUD from the everted membrane. Flushing the central lumen before loading the IUD into the everted catheter, or during delivery and release of the IUD within the everted membrane, increases the lubricity of the IUD within the everted membrane, allowing the IUD to slide out of the everted membrane with reduced friction. Equipping everted catheters for IUD delivery and placement with flushing is particularly useful because some IUDs contain hormonal drugs, coatings, or other therapeutic agents that can become sticky when interacting with the surface of certain polymers used in the catheter's construction.

[0034] The flushing mechanism, whether automated or manual, can facilitate visualization of the uterine cavity using ultrasound, fluoroscopy, or direct endoscopy through the central lumen of the IUD inserter. For example, with the injection of saline, the flushing mechanism through the central lumen can provide the physician with a slightly distended uterine cavity, wherein ultrasound visualization of the IUD within the uterine cavity is used to confirm IUD placement.

[0035] The IUD system can have a transfer mechanism to facilitate loading a commercially available or second-party IUD into the eversion catheter. Once loaded with the IUD, the eversion catheter can be ready for placement into the patient's uterus. The transfer mechanism includes a loading device that retrogradely loads the second-party IUD into the distal end of the eversion membrane and a snare that captures the IUD sutures through the central lumen of the eversion catheter and retracts the IUD sutures. The entire mechanism is contained within a planar support that can be mounted on a standard procedure preparation table. In operation, the loading mechanism can facilitate loading the second-party IUD into the eversion catheter and then delivering it to the patient.

[0036] The everting catheter system used for the IUD placement process can be facilitated by a suction system that is used to hold onto the device during the initial steps of device loading. The suction system can work in conjunction with the distal opening of a pusher that passes through the central lumen of the everting catheter to stabilize the IUD and pull it into position with the everted membrane of the everting catheter system.

[0037] An external catheter system for an IUD placement procedure can utilize a translatable external catheter having a telescoping portion that provides a selected insertion depth within the uterine cavity for placement of an IUD device. The telescoping portion in the external catheter can independently vary and select the insertion depth for IUD placement without requiring changes to any other components of the external catheter system.

[0038] The distal end of the everted membrane at the location of the IUD may have echogenic markers that serve to increase ultrasound contrast, visibility, and detection within the patient's uterus or to enhance real-time visualization of IUD placement.

[0039] The IUD loading system can allow a user to load a separately provided IUD into the eversion catheter system. The loading system can include a holder, a shunt, and a tray fixture to facilitate loading the IUD into the eversion catheter system.

[0040] Another embodiment uses a derivative of the loading system during the manufacturing process to construct an integrated eversion system with a preloaded IUD. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0042] Figure 2A A variation of the everted balloon system is shown in a fully everted configuration.

[0043] Figure 2B is a cross-sectional view of a variation of the system handle.

[0044] Figure 3A A variation of the distal end of the eversion balloon system is shown with the balloon expanded to less than a fully inflated configuration.

[0045] Figure 3B A variation of the distal end of the eversion balloon system is shown with the dilation balloon in a fully inflated configuration.

[0046] Figure 4A A variation of the everting balloon system is shown with the syringe in an attached but not yet deployed configuration.

[0047] Figure 4B A variation of the everting balloon system is shown with the syringe in an attached and deployable configuration.

[0048] Figure 4C Shown Figure 4B A variation of an everting balloon system in which the plunger driver is shown in cross-section.

[0049] Figure 5A Lengths of variations of the eversion balloon system are shown.

[0050] Figure 5B yes Figure 5A Partial cross-sectional view of a variant of the system.

[0051] Figure 5C and Figure 5D Variants of the side and perspective views of a portion of section AA.

[0052] Figure 5E Exploded view of a variant showing part of the system handle and drive gear.

[0053] Figure 5F is a close up view of a variation of the system handle at the ratchet handle shaft.

[0054] Figure 6A is a cross-sectional view of a variation of the system handle.

[0055] Figures 6B to 6D They are respectively Figure 6A Side, top, and cross-sectional views of a variation of an everted balloon system with a system handle.

[0056] Figure 7A and Figure 7B Exploded and perspective views, respectively, of variations of the eversion balloon system.

[0057] Figure 8A is a cross-sectional view of a variation of a three-way connector and adjacent components in a configuration for delivering media pressure to an outer catheter (eg, to an everted balloon).

[0058] Figure 8B is a cross-sectional view of a variation of a three-way connector and adjacent components in a configuration for delivering media pressure to an inner catheter (eg, to a dilation balloon).

[0059] Figure 9 is an exploded view of a variation of a transfer catheter.

[0060] 10A to 10C Variations of methods of delivering material to a target site (eg, delivering reproductive material to the uterine cavity) are shown.

[0061] Figures 11A to 11C Variations of methods of delivering material to a target site (eg, delivering reproductive material to the uterine cavity) are shown.

[0062] 12A to 12E An everted catheter with an everted membrane performing an IUD placement procedure is shown.

[0063] 13A to 13I Additional derivations built into the everted membrane and the distal end of the inner catheter are shown in both side and top views.

[0064] 14A to 14D Other embodiments illustrating advancement and release of an IUD within an everted membrane are shown.

[0065] 15A to 15D An automated one-handed eversion mechanism for IUD placement is shown.

[0066] Figures 16A to 16J A variation of an everted catheter that can deliver an IUD within the uterine cavity is shown.

[0067] 17A to 17I A variation of an everted catheter that can deliver an IUD within the uterine cavity is shown.

[0068] 18A to 18C A mechanism is shown that automatically provides negative pressure during the IUD release step of the delivery process. Additionally, flushing through the central lumen to facilitate the IUD release step can be provided alone or in conjunction with negative pressure.

[0069] Figure 19A An everting catheter system for delivering an IUD is shown.

[0070] Figures 19B to 19D is a close-up view of the everted ductal system.

[0071] Figure 20A The everted catheter system is shown after complete eversion of the balloon during delivery of an IUD.

[0072] Figure 20B A close-up view of the everted balloon and distal end of the IUD.

[0073] Figure 20C is a close-up view of the proximal portion of the eversion catheter system after complete eversion during delivery of the IUD.

[0074] Figures 21A to 21C The process of delivering an IUD in a simulated uterine cavity model is shown.

[0075] Figures 22A to 22E A delivery and loading packaging configuration of an eversion catheter system for delivering an IUD is shown. DETAILED DESCRIPTION

[0076] A balloon system 2 (also referred to as an eversion catheter system) is disclosed that can be used to pass through a blood vessel, such as the cervical canal. The 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 balloon system 2 can have a control system that can be operated with one hand. The balloon system can also be passed through other locations within a patient or animal's body for the purpose of placing the device within a body cavity or lumen.

[0077] Figures 1A to 1E It is shown that the outward-turning 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 an inner catheter lumen 10 or be a solid rod or a flexible mandrel. The outward-turning balloon system 2 can have a media volume 12. The media volume 12 can be a continuous open space between the inner catheter 8 and the outer catheter 4 near the balloon membrane 6. The radially outer end periphery of the balloon membrane 6 can be attached to the distal end of the outer catheter 4. The radially inner end periphery of the balloon membrane 6 can be attached to the distal end of the inner catheter 8. The outward-turning balloon system 2 can be manufactured without an inner catheter 8, for example, where the balloon membrane 6 extends proximally out of the working area to reach a control device (e.g., a pump).

[0078] Figure 1A The eversion catheter system 2 is shown in a non-pressurized configuration. The media volume 12 can be uninflated and unpressurized. The balloon membrane 6 can be relaxed.

[0079] Figure 1BThe everting catheter system 2 is shown to be in both pressurized and non-everted configurations. For example, a pressurizing device (e.g., a pump) at the proximal end of the everting catheter system 2 can be in fluid communication with the medium volume 12. The pressurizing device can deliver a fluid medium such as a pneumatic gas or a hydraulic liquid medium (e.g., saline, water, air, carbon dioxide, or a combination thereof) to the medium volume 12 at a medium pressure 14. When in the everted configuration, the medium pressure 14 in the everting balloon 2 can be about 2 to about 5 atmospheres, and higher medium pressures 14 from about 5 atmospheres to 10 atmospheres are possible, for example, to provide greater eversion capabilities for more difficult or narrow passages in the body.

[0080] The balloon membrane 6 can be expanded and in a tensioned state. The balloon membrane 6 can block the distal end port of the inner catheter lumen 10 .

[0081] Figure 1C The eversion catheter system is shown in an expanded and partially everted configuration. As indicated by arrow 16, the inner catheter 8 can be translated distally relative to and out of the outer catheter 4. 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 to or distal to the distal end of the outer catheter 4. The balloon membrane 6 can block the distal port of the inner catheter lumen 10 or can be opened to allow fluid communication between the inner catheter lumen 10 and the target site.

[0082] Figure 1D The eversion catheter system is shown in an expanded, fully everted, and fully distally extended configuration. As indicated by arrow 16, the inner catheter 8 can be translated distally relative to the outer catheter 4 until the distal end of the inner catheter 8 longitudinally exceeds or becomes coterminous with the distal end of the balloon membrane 6. The distal end port of the inner catheter lumen 10 is unobstructedly accessible and in fluid communication with the target site.

[0083] In the fully expanded configuration, the balloon membrane 6 can form an expanded, everted balloon 18. In the expanded and fully everted configuration, the everted balloon 18 can have a balloon outer diameter 20 and a balloon length 22.

[0084] The balloon outer diameter 20 can be from about 2 mm to about 20 mm, more narrowly from about 2 mm to about 7 mm, such as about 5 mm. The outer diameter can be constant or vary along the length of the everted balloon 18. For example, for use in the cervical canal, the proximal-most portion of the everted balloon outer diameter 20 can be configured to have a smaller outer diameter than the remainder of the everted balloon membrane 24. As an example, a first proximal portion of the everted balloon 18 can have a smaller balloon outer diameter 20, such as from about 2 mm to 4 mm for a length from about 5 mm to about 10 mm from the distal end of the outer catheter 4, and the remaining length of the everted balloon 18 (e.g., from about 4 cm to about 7 cm along the everted balloon 18) can have a balloon outer diameter 20 of about 4 mm to about 7 mm. The outer diameter of the proximal end of the everting balloon 18 can have a consistent balloon outer diameter 20 of about 3 mm to about 6 mm, e.g., for delivery in the cervix or urethra, and the distal-most outer approximately 2 cm to about 3 cm of the everting balloon 18 can have a balloon outer diameter 20 of about 10 mm to about 20 mm, e.g., to create a seal with and anchor within the endocervical os of the uterine cavity or bladder.

[0085] 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 a blood vessel, or to entrap body fluids, cells or tissues.

[0086] The everted balloon length 22 can be about 2 cm to about 31 cm, more narrowly about 2 cm to about 25 cm (e.g., for use in the male urethra), more narrowly about 2 cm to about 12 cm for placement of an IUD, and more narrowly about 3 cm to about 6 cm for in vitro fertilization, insemination procedures, or delivery of instruments and endoscopes, such as about 4 cm, about 7 cm, about 15 cm, and about 30 cm.

[0087] Figure 1E The eversion catheter system is shown in an expanded and partially or completely everted configuration. As shown 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, exiting the distal port of the inner catheter lumen 10 and entering the target site. The tool 26 can be an IUD, a biopsy tool, an endoscope, an ultrasound probe, a plug, a cautery tool, or a combination thereof. Suction can be applied 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.

[0088] To retract and reposition or remove the balloon membrane 6, the inner catheter 8 can be pulled proximally to pull the balloon membrane 6 back into the outer catheter 4. The balloon membrane 6 can be deflated or the medium pressure reduced 14, and the entire system can be retracted from the target site.

[0089] 2 shows that the everting 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 detachably attached to the outer catheter 4. For example, the outer catheter 4 and the inner catheter 8 and the balloon can be removed from the system handle 30 and replaced. The system handle 30 can be sterilizable. The medium (e.g., liquid or gas) delivered by the system handle 30 can be filled into the system handle 30 before attaching or replacing the catheter and balloon.

[0090] The system handle 30 may have a rigid system handle housing 34 and a rigid pump rod 36 rotatably attached to the system handle 30 housing at a pump rod axis 38 .

[0091] The system handle 30 can have an inlet port 40. The eversion balloon system 2 can have a pressurization source. The pressurization source can have a flexible reservoir 42 or a fluid supply container or bag. The fluid bag can be filled with hydraulic and / or pneumatic fluid.

[0092] The inlet port 40 can be a female Luer connector and connection. The inlet port 40 can be in fluid communication with the flexible reservoir 42 through an inlet-reservoir passage 44. The liquid reservoir 42 can be between the rigid pump rod 36 and the rigid system handle housing 34. The inlet port 40 can extend outside the proximal end of the system handle housing 34. The inlet port 40 can be configured to be attached to a liquid source (e.g., a hose, a tube, or a supplemental reservoir configured to deliver liquid to the liquid reservoir 42 through the inlet port 40). The inlet port 40 can have a proximal check valve or a one-way valve that is configured to allow flow to the reservoir 42 and prevent backflow (e.g., proximal flow flows out of the inlet port 40 from the reservoir 42).

[0093] The liquid reservoir 40 may be in one-way (eg, via a check valve) or two-way fluid communication with the media volume 12 .

[0094] When the fluid reservoir 42 contains fluid, the pump rod 36 can be rotated away from the system handle housing 34 as the fluid reservoir 42 expands, as indicated by pump rod rotation arrow 46. The pump rod 36 can be rotated toward the system handle housing 34 to compress the fluid reservoir 42, e.g., to force fluid from the fluid reservoir 42 into the media volume 12 of the everted balloon 18.

[0095] The pump rod 36 can provide a pumping (eg, suction) action to provide suction to draw fluid from the media volume 12 of the everted balloon 18. With each compression, a spring within the rod can facilitate the pumping action of the rod to open the rod (not shown).

[0096] The system handle 30 can have an advancement slider 48. As indicated by arrow 50, the advancement slider 48 can be translated proximally and distally relative to the system handle housing 34. The advancement slider 48 can be configured to translate the inner catheter 16 relative to the outer catheter 4. For example, pushing the advancement slider 48 distally can push the inner catheter 8 distally relative to the outer catheter 4 and evert the inverted balloon 18. Pulling the advancement slider 48 proximally can pull the inner catheter 8 proximally relative to the outer catheter 4 and retract the inverted balloon 18. The advancement slider 48 can have a gear, a ratchet with a rack, and a rotating advancement screw.

[0097] The advancement button may be an advancement ratchet or roller that engages into or with the inner catheter 8 to allow the inner catheter to translate 16 .

[0098] The doctor can use one hand to advance the inner catheter 8, evert the balloon 18, pass the everted balloon 18 through the cervical canal, and enter the uterine catheter through the inner catheter lumen 10.

[0099] The fluid reservoir 42 can be pressurized before the distal tip of the outer catheter 4 is placed at the cervix. The fluid reservoir 42 can have a proximal check valve or one-way valve on 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 bag can be attached to a distal pressure check valve 52, which can open when the pressure from the fluid bag (e.g., approximately 1 atmosphere of pressure from the fluid reservoir) is at or above the distal check valve limit pressure. The distal pressure check valve 52 can then deliver fluid and pressure from the fluid reservoir 42 to fill and pressurize the media volume 12 of the catheter and everting balloon 18. The distal pressure check valve 52 can be a one-way valve that allows hydraulic or pneumatic fluid or media to flow from the fluid reservoir 42 to the media volume 12 of the catheter and everting balloon 18. Atmospheric pressure ratings higher and lower than 1 atmosphere are also possible for the remote pressure check valve 52 , such as about 0.5 atmosphere to about 2 atmospheres.

[0100] During pressurization of the fluid reservoir 42 (e.g., by pumping with the pump rod 36 or from the inlet port through the proximal check valve 54), a pressure greater than the reservoir limit pressure (e.g., 1 atmosphere) of the distal pressure check valve 52 can cause the distal pressure check valve 52 to open and allow fluid medium to flow from the fluid reservoir 42 into the medium volume 12 of the catheter and the eversion balloon 18. The pressurization in the medium volume 12 of the catheter and the eversion balloon 18 can expand and evert the eversion balloon 18 under the action of the hydraulic force. After the eversion balloon 18 is fully everted, excess medium can remain in the fluid reservoir 42.

[0101] 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. Thus, the fluid reservoir 42 can be used to stage or maintain additional potential hydraulic pressure stored in the system for use by the user (e.g., a physician) as needed by rotating the pump lever 46 without changing hand position or using a second hand.

[0102] Inner conduit 8 can stretch through three-way connector 56. Inner conduit 8 can translate (that is, advance and retract) through three-way connector 56, while keeping sealing (that is, there is not the situation that the medium volume 12 of catheter or everting balloon 18 loses pressure). Inner conduit 8 (for example, if solid rod or mandrel) can be constructed to withstand the hydraulic pressure of about up to 5 atmospheres or about 10 atmospheres and about 2 pounds or about 5 pounds of translation (for example, advance, retract, stretch, compress or their combination) power during eversion process and do not deform. As an example, in eversion process, when everting balloon membrane 6 passes through curved or tortuous anatomical structure, inner conduit 8 with inner conduit lumen 10 (for example, through cavity) can withstand medium pressure 14, tensile force and compressive force and rotational force, to allow instrument, catheter, medium or material to pass in through cavity. The movement of the propulsion button on the handle makes inner conduit 8 move in three-way connector 56 and pass outer conduit 4. The everting balloon 18 can then be everted and rolled out of the outer catheter 4 and through the target site (eg, the cervical canal).

[0103] After entering the target site, for example, the user can activate the pressure release controller 60 to release or reduce the pressure of the media volume 12, thereby shrinking or reducing the outer diameter of the outward-facing balloon 18, and / or manually retract the outward-facing balloon 18 and the inner catheter 8 and the rest of the system by retracting the push slider 48 or pulling the system handle 30 proximally.

[0104] Once the everting balloon 18 has passed through the biological lumen to be traversed (e.g., the cervical canal or urethra), the everting balloon system 2 can increase the pressure in the everting balloon 18, for example, by increasing the diameter of the everting balloon 18, or simultaneously maintain the everting balloon 18 at a constant diameter (e.g., for a fiber-reinforced everting balloon 18 or a balloon membrane 6 constructed of a non-expandable material). The pump rod 36 can be depressed to increase the pressure in the fluid reservoir 42 and release the distal pressure check valve 52. The proximal check valve 54 can prevent or minimize the leakage or infiltration of the fluid medium (e.g., pneumatic or hydraulic) into the proximal direction and out of the inlet port 40.

[0105] The user can rotate the pump shaft 36, for example, to increase the pressure in the fluid reservoir 42, the media volume 12, and the everting balloon 18. The balloon outer diameter can then increase, further advancing the diameter of the biological lumen. For example, the everting balloon 18 can dilate the cervix and endocervical canal. A tool, such as an endoscope, an instrument, Hegars, other devices that further increase the diameter of the cervix, or a combination thereof, can then be inserted into the dilated endocervical canal while the everting balloon system 2 is in the endocervical canal, or subsequently, the everting balloon system 2 can be withdrawn from the endocervical canal.

[0106] Pump lever 36 may deliver tactile feedback to the user indicating the pressure of everted balloon 18. Everted balloon system 2 may have a pressure gauge that indicates the pressure in media volume 12, such as in fluid reservoir 42 and / or in the catheter and everted balloon 18.

[0107] 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 media volume 12 of the catheter and eversion balloon 18 .

[0108] The pressure relief controller 60 can be connected to the hemostatic valve 58. The hemostatic valve 58 can have a seal or sealing gasket. The pressure relief controller 60 can be configured to open and close the sealing gasket by rotating the sealing cap, or to open a connection to a separate drainage tube (not shown) in fluid communication with the media volume 12.

[0109] The pressure relief control 60 can be located on the handle 30 where the user's thumb is located, away from the advancement slider 48 and in line with the movement of the advancement slider 48. The pressure relief control 60 can be operated by the same hand that the user uses to operate the advancement slider 48 and the pump lever 36.

[0110] The pressure release control and handle may be used to advance and deliver the IUD with one hand by the user.

[0111] The user can perform the following operations of everting balloon system 2 with one hand (e.g., without using their other hand or having another operator) without changing the position of the hand:

[0112] a. Pressurizing the liquid reservoir 42;

[0113] b. The distal end of the eversion balloon system 2 is placed or positioned on the patient's cervix;

[0114] c. Control the position of the eversion balloon system 2 throughout use;

[0115] d. Advancing the inner catheter 8 and the balloon membrane 6;

[0116] e. increasing the diameter of the eversion balloon 18 by pumping additional hydraulic pressure from the fluid reservoir 42;

[0117] f. Retract the inner catheter 8 and the balloon membrane 6; and

[0118] g. Activate the pressure release control 60 to remove or release pressure from the everting catheter system.

[0119] Structurally, the buttons and actuators that implement these functions can be located on the handle to allow the operator to manipulate these features without changing hand position or without needing to use the other hand. For example, the advancement and retraction of the inner catheter 8 can be performed by a sliding mechanism or gear located on the upper side of the handle about 4 inches from the proximal end of the handle or handle grip. The lever and ratchet mechanism can be located at a position about 2 inches to about 4 inches from the proximal end of the handle grip below or on the lower side of the handle. Additional actuators can be placed on the side of the handle grip about 3 inches to about 4 inches from the proximal end of the handle grip, or on the top or bottom of the handle grip about 3 inches to about 4 inches from the proximal end. The position of the buttons and actuators is tactile for the operator without visual confirmation, thereby allowing the user to maintain visual contact with the patient or a visualization source (e.g., an endoscopic monitor or ultrasound image).

[0120] During use of the eversion balloon system 2, the user can utilize their free hand to handle an ultrasound probe, a retractor (e.g., if the cervix is difficult to access or severely retroverted or anteverted due to anatomy), to stabilize the patient, or other instruments, or a combination thereof.

[0121] Figure 3A The inner catheter 8 is shown as being attached to a dilation balloon 62 or inner catheter balloon. The dilation balloon 62 can be radially inward of the outward-facing balloon 18. The distal and proximal ends of the dilation balloon 62 can be attached and sealed to the inner catheter 8. The inner catheter 8 can have a dilation balloon port 64 longitudinally located within the dilation balloon 62. The dilation balloon port 64 can be in fluid communication with a fluid pressure source at the proximal end of the outward-facing balloon system 2, such as in or attached to the system handle 30. The dilation balloon 62 can be inflated and deflated through the dilation balloon port 64.

[0122] The dilation balloon 62 can be more compliant, equally compliant, or less compliant than the everting balloon 18. The wall of the everting balloon 18 can be thicker, thinner, or the same thickness as the wall of the dilation balloon 62. The everting balloon 18 can be made of one or more polymers, including silicone, polyurethane, 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 can be made of any of the materials mentioned for the everting balloon 18.

[0123] The eversion and / or expansion balloon membrane 6 may have a thickness of about 0.001 inches to about 0.004 inches.

[0124] The eversion and / or expansion balloon 18, 62 may be internally coated with a lubricating material such as silicone oil, mineral oil, other lubricants, or combinations thereof. The lubricating coating may reduce friction within the balloon during the eversion process.

[0125] The exterior of the everted and / or expanded balloon 18, 62 can be smooth, for example, the balloon can be extruded from tubing. 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 in a target body cavity (e.g., the cervical canal or urethra). The outer diameter of the balloon can vary in size. For example, the distal-most portion of the everted balloon 18 can be manufactured to have a larger outer diameter to accommodate larger blood vessel sizes or to accommodate expansion that can extend into the bladder.

[0126] During use, the everting balloon 18 can pull the inner catheter 8 into the cervical canal. When the everting balloon 18 is deployed into the cervical canal, the dilation balloon 62 can be located in the cervical canal.

[0127] Figure 3B It is shown that the expansion balloon 62 can be inflated by delivering pressurized fluid through the expansion balloon inflation port 64. The expansion balloon 62 can be inflated inside the everted balloon 18. The expansion balloon 62 can be inflated to an expansion balloon diameter 66.

[0128] The expansion balloon 62 can have a predetermined or molded size and shape. For example, the expansion balloon 62 can have an expansion balloon diameter 66. For example, the maximum expansion balloon diameter 66 or maximum eversion balloon diameter can be about 2 mm to about 12, 30 mm, and for some applications, up to about 20 mm in diameter (e.g., for the cervix), narrower from about 2 mm to about 10 mm (e.g., for the urethra), narrower from about 6 mm to about 12 mm, narrower from about 2 mm to about 7 mm (e.g., for the urethra), narrower from about 3 mm to about 4 mm (e.g., for the male urethra). The expansion balloon 62 can be inflated to a preset outer diameter. (The expansion balloon outer diameter 66 can be equal to or less than the expansion diameter required for the body cavity (e.g., the cervix)). The eversion balloon 18 can have a maximum eversion balloon diameter 66 that is equal to or less than the maximum expansion balloon diameter.

[0129] The dilation balloon 62 can be inflated to the same or higher pressure than the eversion balloon 18. For example, the dilation balloon 62 can have a dilation balloon pressure of about 4 atmospheres to about 12 atmospheres, and can be as high as about 20 atmospheres, for example, to disrupt pathological stenosis or conditions within a body lumen.

[0130] When the expansion balloon 62 is inflated, the everted balloon 18 can expand to the expansion balloon diameter 66 due to the expansion of the expansion balloon 62. The inflation medium within the everted balloon 18 can remain within the balloon or retract before, during, and / or after the inflation of the expansion balloon 62. For example, due to the friction of the everted balloon membrane 6 against the body cavity in the everted state, the everted balloon membrane 6 can be used to maintain the position of the expansion balloon 62 during the expansion process without accidentally advancing or retracting the system within the body cavity during the expansion process.

[0131] When the eversion balloon diameter expands beyond the strain limit of the eversion balloon 18, the expansion balloon 62 can inflate and potentially tear or break the eversion balloon 18. The inflation medium within the eversion balloon 18 can remain within the balloon or retract before, during, and / or after inflation of the expansion balloon 62, such as to exit the eversion balloon 18 if the eversion balloon 18 tears.

[0132] Upon expansion of the dilatation catheter, the everting balloon 18 can rupture or tear along an intended line. For example, the everting balloon 18 can be torn by a mechanical device on or within the outer catheter 4, a sharp tool on the proximal portion of the inner catheter 8 (which becomes active when the dilatation balloon 62 is fully everted and inflated), and / or further advancement of the inner catheter 8, which causes the everting balloon 18 to detach from the attachment or bond between the everting balloon 18 and the inner catheter 8 at the distal end of the inner catheter 8. The tearing or splitting of the everting balloon 18 can be accomplished by weakening the everting balloon 18 by a mechanical indentation or seam in the balloon membrane 6 that splits upon reaching a specific strain limit, such as along a helical line, a lateral line, a longitudinal line, or a combination thereof. The everting balloon membrane 24 can be manufactured to have an increased longitudinal axial orientation of the molecular structure by tensioning or expanding the membrane along the longitudinal axis of the balloon during the balloon formation process, which can promote longitudinal rupture if the everting balloon membrane 24 splits or tears. Radial tearing of the everted balloon 18 can be facilitated by creating a balloon membrane 6 with a greater radial orientation of the molecular structure by radially expanding or tensioning the balloon membrane 6 during the balloon formation process.

[0133] The system handle 30 can hold an inflation medium that will be delivered to and from the everting balloon 18 and the dilation balloon 62. The inflation medium can be in a liquid reservoir 42 (e.g., a fluid bag or a syringe piston). After the everting balloon 18 is inflated and everted, the inflation medium can be delivered to the dilation balloon, for example, via a valve. The system handle 30 can have a gear or ratchet that is configured to advance the inner catheter 8. The outer catheter 4 can extend approximately 25 cm to the distal end of the system handle 30. The system handle 30 and the actuator can be controlled by one hand to inflate the everting balloon 18 and the dilation balloon 62.

[0134] The dilation balloon 62 may be positioned in and dilate the cervix.

[0135] Figures 4A to 4C The inner catheter 8 is shown in a fully retracted position within the outer catheter 4 .

[0136] Figure 4A The system handle 30 is shown to have 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 have a finger grip, 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 5cc to about 20cc, such as about 5cc or about 20cc. The open distal port of the syringe can be attached to the syringe connector 70 and be in fluid communication with the syringe connector 70. The syringe connector 70 can have a distal pressure valve 52. The syringe connector 70 can be rotatably attached to the system handle housing 34. The syringe 74 can have a plunger 76 that can be longitudinally translated with the rest of the syringe 74. The syringe 74 can be filled with any medium disclosed herein, such as saline, air, a gas, or a combination thereof. The reservoir 42 can have two separate syringes 74, each attached to and in fluid communication with the same or different syringe connector 70. For example, a first syringe may be in fluid communication with eversion balloon 18 and a second syringe may be in fluid communication with expansion balloon 62 .

[0137] The syringe 74 may be locked to the syringe connector 70 .

[0138] The outer catheter 4 may have an outer catheter distal end 78. The outer catheter distal end 78 may be, for example, an atraumatic end such as an acorn end or a stopper. The outer catheter distal end 78 may be configured to prevent the outer catheter 4 from being inserted too far into a target biological lumen (e.g., the cervical canal).

[0139] The outer catheter distal end 78 can have an outer catheter distal port 80. The outer catheter distal port 80 can be large enough to allow the inner catheter 8 and balloon to pass through.

[0140] Figure 4B The syringe connector 70 and syringe 74 are shown to be rotatable, as indicated by the arrows, so that the longitudinal axis of the syringe 74 can be parallel or co-linear with the longitudinal axis of the outer catheter 4. The syringe connector 70 can be fixed at an angle relative to the rest of the system handle 30. The plunger drive plate 72 can be rotated and / or translated to contact or nearly contact the proximal end of the syringe plunger 76.

[0141] Figure 4CThe system handle 30 is shown as having a plunger driver 82. The plunger driver 82 can have 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 squeezed as shown by arrow 87 to rotate the plunger drive screw 84, or the linear rack. The plunger drive screw 84 or the 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 external threads of the plunger drive screw 84. The plunger drive collar 86 can be translatably fixed to the plunger drive plate 72. When the ratchet handle 68 is squeezed, the plunger drive collar 86 and the plunger drive plate 72 can translate distally relative to the rest of the syringe 74. The plunger drive plate 72 can contact the plunger 76 and press the plunger 76 in the distal direction shown by the arrow.

[0142] The ratchet handle 68 may have a ratchet to prevent the direction of the plunger driver from being reversed, such as to prevent the plunger 76 from translating toward the proximal end. A release lever may be rotated or deployed to release the ratchet mechanism to disengage the assembly, exit the system, or redeploy. The ratchet handle 68 may have no ratchet or a bidirectional ratchet, such as to control the direction of the plunger driver 82, such as to allow proximal and distal translation of the plunger 76. The plunger drive plate 72 may be fixed to the plunger 76 or contact but not fixed to the plunger 76.

[0143] Squeezing the ratchet handle 68 may depress the syringe plunger 94. Depressing the syringe plunger 94 may force inflation medium from the syringe 74 into the medium volume 12 of the dilation and / or eversion catheter 18, eg, pressurizing the corresponding balloon.

[0144] Figures 5A to 5F The system handle 30 is shown to have a stopcock and check valve 88 extending from the tee connector 56. The stopcock and check valve 88 can be in fluid communication with the media volume 12. The stopcock and check valve 88 can be external (as shown) or internal to the system handle housing 34. The stopcock and check valve 88 can be accessed to add media, remove media, or check the media pressure in the media volume 12.

[0145] The system handle 30 can have one or more syringe detents 90. The syringe detent 90 can 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 housing 34. The syringe detent 90 can be configured to allow the syringe 74 to slide into and out of the detent along the longitudinal axis of the syringe 74.

[0146] The system handle housing 34 can include a deflector plate 92. The outer and / or inner catheters 4, 8 can be pressed against the deflector plate 92. The deflector plate 92 can change or deflect the path of the outer and inner catheters 4, 8 in a longitudinal axial direction toward the target site. The deflector plate 92 can include molded or formed grooves, pins, plates, panels, or a combination thereof. The outer catheter 4 can be manufactured with a predetermined curve to accommodate the curved path within the system handle housing 34.

[0147] The system handle housing 34 can have a handle grip 96. The inner catheter 8 can have a linear inner catheter grip length 98. The inner catheter grip length 98 can be the length of the inner catheter 8 in the handle grip 96 in the non-inverted state. The inner catheter grip length 98 can be approximately 12 cm when the inner catheter 8 is in the non-inverted state, for example, corresponding to an everted length of approximately 6 cm for the everted balloon membrane 24 for the inner catheter grip length 98 (e.g., approximately 50% of the inner catheter grip length 98). Optionally, the inner catheter 8 can be configured to coil on wheels, have telescoping sections, or have folding and unfolding sections to reduce the amount of distance required within the system handle housing 34 to accommodate the length of the inner catheter 8 in the non-inverted state.

[0148] The system handle 30 may have a reservoir-catheter passage 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-catheter passage 100 may be a tube from the syringe connector 70 to the inner catheter 8.

[0149] The system handle 30 can have an access channel 102 that extends from an outer surface of the system handle connector 32 to an outer surface of the system handle housing 34. The access channel 102 can terminate proximally at a proximal access port 104.

[0150] Inner catheter 8 may extend through access channel 102. One or more tools or fluids may be inserted through proximal access port 104 and access channel 102 into and through or near inner catheter 8 and / or suction may be applied thereto.

[0151] The system handle 30 may have one or more drive gears 106. The drive gears 106 may be located on one or opposite sides of the access channel 102. The drive gears 106 may encroach upon or impinge upon the access channel 102. The drive gears 106 may be rotatably attached to the system handle housing 34 via a drive gear shaft 108. The drive gears 106 may have a toothed gear portion and a drive gear recess 124. The inner catheter 8 may extend through the drive gear recess 124. The drive gears 106 may frictionally push and pull the inner catheter 8. One or more of the drive gears 106 may extend and be exposed outside the system handle housing 34. For example, an exposed drive gear 106 may be rotated by pressing the exposed drive gear 106 with a user's palm or finger (e.g., thumb). The exposed drive gear 106 may interdigitally engage with one or more unexposed drive gears 106. Rotating one of the drive gears 106 may rotate the other drive gears 106 interdigitally engaged with the first drive gear 106.

[0152] The system handle housing 34 can have a system handle housing first side 110 and a system handle housing second side 112. The system handle 30 can be made by attaching the system handle housing first side 110 to the system handle housing second side 112. Each drive gear shaft 108 can be rotatably attached to the system handle housing first side 110 and the system handle housing second side 112.

[0153] The pump rod shaft may be a ratchet handle shaft 114. The ratchet handle 68 may rotate about the ratchet handle shaft 114.

[0154] The system handle 30 may have a plunger drive rack 116. The plunger drive rack 116 may be fixed to the plunger drive plate 72. The plunger drive plate 72 may extend vertically from the proximal end of the plunger drive rack 116. The plunger drive rack 116 may have unidirectional or bidirectional drive teeth 118 on one side toward the plunger drive plate 72.

[0155] The system handle 30 can have a ratchet handle spring 120 compressed between the system handle housing 34 and / or the ratchet handle 68 and / or a ratchet arm 122. The ratchet handle spring 122 can reset the ratchet handle 68, such as by rotating the ratchet handle 68 forward after the ratchet handle 68 has been squeezed.

[0156] The system handle 30 can have a ratchet arm 122 or an actuating pawl. The ratchet arm 122 can be mechanically attached to the ratchet handle 68, for example, to the handle spring 120. The ratchet arm 122 can be positioned in a track that limits the movement of the ratchet arm 122 to longitudinal translation relative to the syringe 74. The proximal end of the ratchet arm 122 can be bent into a U-shape. The distal end of the ratchet arm 122 can abut against the ratchet teeth. The ratchet arm 122 can be configured to pull the plunger drive rack 116 distally when the ratchet handle 68 is squeezed. The ratchet arm 122 is configured to move proximally relative to the plunger drive rack 116 when the ratchet handle 68 returns to a reset position.

[0157] The system handle 30 can have a locking pawl (not shown) that can be spring-loaded between the system handle housing 34 and the plunger drive rack 116, for example, allowing the plunger drive rack 116 to translate distally and preventing the plunger drive rack 116 from translating proximally unless the locking pawl is manually released from the plunger drive rack 116 via the release lever 126.

[0158] like Figure 5B As shown, the outer catheter 4 can have an outer catheter length 128. The outer catheter length 128 can be about 4 cm to about 35 cm, more narrowly about 10 cm to about 24 cm, such as about 17 cm.

[0159] 6A to 6D It is shown that the system handle 30 can have an inner catheter drive tray 130 translatably attached to the system handle housing 34. The proximal length of the inner catheter 8 can extend proximally from the system handle housing 34. The proximal length of the inner catheter 8 can be in, on, or near the inner catheter drive tray 130.

[0160] The syringe 74 can have a syringe loading connector 132, such as a Luer connector, at the distal or proximal end of the syringe 74 (e.g., the end away from the system handle housing 34). A delivery tube 133 or delivery device can be attached to the syringe loading connector 132 and pressurized medium can be delivered to the syringe 74 through the syringe loading connector 132.

[0161] The delivery tube 133 or delivery device can be disconnected from the syringe loading connector 132 before deploying the everted balloon 18, as shown in FIG. Figure 6C The delivery tube 133 can be wrapped within the handle grip 96 and connect the syringe 74 and its pressurized medium to the three-way connector 56 and the inlet port 40 of the hemostasis valve 58 or the expansion balloon 62.

[0162] 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 into and out of the access port detents 134 transverse to the longitudinal axis of the inner catheter drive tray 130.

[0163] 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 (eg, advance the inner catheter 8 to a target site). The inner catheter can deliver an IUD, instrument, device, endoscope, or dilation balloon.

[0164] As disclosed herein, the system handle housing 34 may have a fluid connection between the syringe 74 and the outer catheter 4 .

[0165] The ratchet arm 122 can extend away from the drive rack 116 to form a release lever 126, as shown. Figure 6A One or more other release levers 126 may extend from other locations on the system handle 30, such as Figure 6B and Figure 6D The release lever 126 can be rotated to disengage the ratchet arm 122 from the drive rack 116 .

[0166] The ratchet handle 68 can have a safety lock hole 136. A safety lock having a cable or rod can removably extend through the safety lock hole 136, for example, to create an interference fit against the system handle housing 34 and prevent the ratchet handle 68 from rotating, for example, to prevent accidental or premature delivery of media from the syringe 74.

[0167] The ratchet handle 68 can be laterally divided into a catheter sub-handle 138 and a media sub-handle 140. The catheter sub-handle 138 can be configured to control the advancement of the inner catheter drive tray 130. The media sub-handle 140 can be configured to control the pressure of the media delivered from the syringe 74. The catheter sub-handle 138 can be attached to the inner catheter drive rack. The media sub-handle can be attached to the plunger drive rack.

[0168] The ratchet handle 68 can control the syringe 74 to apply medium pressure to the eversion balloon 18 and the dilation balloon 62 and independently control the translational movement of the inner catheter 8.

[0169] Figure 7A and Figure 7BThe inlet port 40 is shown to 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 polymer acorn tip, for example to help stabilize the eversion system 2 at the body cavity opening or to prevent the outer catheter 4 from being accidentally advanced within the body cavity.

[0170] The reservoir-catheter channel 100 can extend from the tee connector 56 to outside the system handle housing 34. The proximal end of the reservoir-catheter channel 100 can 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 can be connected to a fluid reservoir 42 (not shown).

[0171] Figure 8A The three-way connector 56 is shown to have a hemostatic valve 58. The three-way connector 56 can have or be a Touhy-Borst Y-connector. The inner catheter 8 can extend through the three-way connector 56.

[0172] The three-way connector 56 can have a distal washer 142 positioned between the reservoir-catheter passageway 100 and the system handle connector 32. The distal washer 142 can have a cylindrical distal washer port 144 extending through the radial middle of the distal washer 142. The distal washer port 144 can have a distal washer port diameter.

[0173] The three-way connector 56 can have a proximal gasket 146 adjacent to the distal gasket 142. The proximal gasket 146 can be located between the reservoir-catheter passage 100 and the proximal outlet through which the inner catheter 8 exits the three-way connector 56. The proximal gasket 146 can be more compliant, equally compliant, or less compliant than the distal gasket 142. The proximal gasket 146 can have a cylindrical proximal gasket port 148 extending through the radial middle of the proximal gasket 146. The proximal gasket 146 can have a proximal gasket port diameter.

[0174] The inner catheter 8 can have an inner catheter minor diameter length 150 and an inner catheter major diameter length 152 proximal to the inner catheter minor diameter length 150. The inner catheter 8 can have an inner catheter proximal inflation hole 154 at the distal end of the inner catheter major diameter length 152. The inner catheter proximal inflation hole 154 can be in fluid communication with the open distal end of the inner catheter lumen 10 and / or the dilation balloon port 64.

[0175] Positive media pressure 14 or flow can be delivered as indicated by the arrows through the reservoir catheter passage 100 to the tee connector 56. The inner catheter major diameter length 152 can occlude, plug, and / or seal the proximal gasket port 148. The positive media pressure 14 or flow can be delivered through the gap between the outer diameter of the inner catheter 8 (e.g., along the inner catheter minor diameter length 150) and the inner diameter of the distal gasket port 144 and delivered to the media volume 12 between the outer catheter 4 and the inner catheter 8, for example, to the everted balloon 18.

[0176] Figure 8B The inner catheter 8 is shown as being able to translate distally as indicated by the arrow, at least until the inner catheter large diameter length 152 moves into the distal gasket port 144. The inner catheter large diameter length 152 can slide through the proximal gasket port 148. The inner catheter large diameter length 152 can close, plug, and / or seal the distal gasket port 144 and / or abut the distal gasket 142. The medium 155 flowing out of the reservoir-catheter passageway 100 can be forced to flow into the inner catheter proximal inflation hole 154. The medium 155 can flow down the inner catheter lumen 10, for example, to the dilation balloon 62.

[0177] An exemplary procedure for delivering an IUD (not shown) or dilating a body cavity (e.g., the cervical canal) may include:

[0178] 1. The syringe 74 can be loaded onto the system handle 30. The system handle 30 can be a separate, reusable item in which the everted catheter and syringe filled with the medium 155 can be attached to the rest of the system before use. Alternatively, the system handle 30 can be provided to the end user pre-assembled and pre-filled with the rest of the system, or a combination thereof.

[0179] 2. The distal end of the eversion balloon system 2 can be placed at the exocervix.

[0180] 3. The ratchet handle 68 can be depressed. The first to two clicks of the ratchet (i.e., when the locking pawl passes over the ratchet teeth) can depress the syringe plunger 94 and pressurize the everted balloon 18. The everted balloon 18 can be pressurized to 4 to 6 atmospheres.

[0181] 4. The ratchet handle 68 can be further depressed (or released to rotate back and then further depressed). The next set of clicks on the ratchet handle 68 can indicate advancement of the inner catheter 8. This can be achieved by the ratchet mechanism rotating a gear on the inner catheter 8 and / or translating a linear rack to advance the inner catheter 8.

[0182] 5. The ratchet handle can be further depressed (or released to rotate back and then further depressed). The inner catheter 8 can continue to advance until the eversion balloon is fully deployed and everted. The expansion balloon 62 can be located on the distal end of the inner catheter 8.

[0183] 6. The ratchet handle 68 can be further depressed. The next click of the ratchet can decompress the everted balloon 18 or deliver an IUD (not shown).

[0184] 7. The ratchet handle 68 can be further depressed. The next click of the ratchet can change the pressurized outlet of the syringe 74 from everting the balloon 18 to expanding the balloon 62, or the action can deliver an IUD (not shown). For example, this can be achieved by:

[0185] a. Use the ratchet mechanism to rotate the valve,

[0186] b. Manually rotate the valve, and / or

[0187] c. Advancing the inner catheter 8 to the position where the inner catheter proximal expansion hole 154 or port is exposed to the expansion medium, such as Figure 8A and Figure 8B shown.

[0188] 8. The ratchet handle 68 can be further depressed. The next set of clicks on the ratchet can indicate the inflation of the dilation balloon 62.

[0189] 9. The expansion balloon 62 may rupture the overlying everted balloon 18.

[0190] 10. The amount of force used to dilate the biological lumen can be controlled by a pressure relief valve or the volume of medium 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 housing 34. The dilation balloon 62 can dilate the cervix from approximately 6 atmospheres to approximately 20 atmospheres. The balloon 62 can initially deliver a pressure of approximately 10 atmospheres to approximately 12 atmospheres, and the pressure decreases as the cervix is dilated and the dilation process is complete. The system can deliver a known volume of medium 155 into the dilation balloon 62 without quantifying or measuring the medium pressure 14.

[0191] 11. The dilation process can be observed by ultrasound or radiography.

[0192] 12. The pressure release button on the system handle 30 can be activated to remove or reduce the inflation pressure in the media volume 12 in the inner catheter lumen 10.

[0193] 13. The syringe plunger 94 may be retracted to draw a vacuum from the inner catheter lumen 10 and the dilation balloon 62, eg, to release the dilation balloon 62 from the cervix, and / or to deflate the dilation balloon 62, eg, to facilitate removal of the eversion balloon system 2 from the cervix.

[0194] 14. The eversion balloon system 2 can be re-pressurized, for example, if additional dilation force is needed in the cervix. For example, if additional stenosis is visible in the cervix, the dilation balloon 62 can be re-placed in the area of additional stenosis and inflated.

[0195] The external catheter system can be used to enter 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, in vitro fertilization (IVF) or fertilization products, such as hormones) media 155 or materials, contrast agents, dyes, therapeutic agents, sclerosing agents for treating the endometrium, inflatable media, or combinations thereof into the cavity. For example, a transfer catheter inserted through the inner catheter lumen 10 can be used to deliver the reproductive media to the uterine cavity.

[0196] Figure 9 A transfer catheter 156 or insemination catheter is shown having a transfer connector 158 (e.g., a female Luer connector), a strain relief length 160, and a transfer tube 162. The transfer tube 162 can hold a reproductive medium. The transfer tube 162 can have a proximal length having a proximal length diameter that is greater than a distal length diameter of the distal length of the transfer tube 162. A delivery force, such as positive fluid pressure, can be transferred through the transfer connector 158 and the strain relief length 160 to push the contents of the transfer tube 162 into the target site.

[0197] The transfer catheter 156 can be attached to or inserted through the inlet port 40. The transfer tube 162 can hold embryos, such as for in vitro fertilization or IVF. The embryo transfer catheter 156 can transport embryos through the system and into the uterine cavity. The transfer catheter 156 can hold sperm and pass it through the system to the uterine cavity for an intrauterine insemination procedure. The transfer catheter 156 can hold and transport other materials, such as drug deposits, therapeutic agents, instruments, endoscopes, cytology brushes, other catheters, or combinations thereof, through the system and into the uterine cavity. The transfer catheter 156 can be connected to a vacuum source to aspirate material from the uterine cavity or other body cavities and lumens.

[0198] The transfer catheter 156 and / or material can be loaded into the inner catheter lumen 10 before the eversion balloon 18 is everted inside or outside the vessel or body cavity. For example, in the case of delivering reproductive material to the uterine cavity, the transfer catheter 156 can be loaded with washed and prepared semen in the transfer tube 162, and the transfer catheter 156 can be placed in the inner catheter lumen 10.

[0199] A guidewire may be inserted through the transfer catheter 156 and / or the rest of the system, for example, to guide the tube or system to the target site 164. The guidewire may be used for recanalization.

[0200] Inner catheter 8 can be extended and eversion balloon 18 can be everted and deployed through the cervix and into the uterine cavity. Simultaneously or subsequently, transfer catheter 156 can be advanced through inner catheter lumen 10 into the uterine cavity. Once fully everted, or when transfer catheter 156 is extended from inner catheter 8 or exposed beyond eversion balloon membrane 24, reproductive material 166 in transfer catheter 156 can be deposited using syringe 74, a squeeze bulb, a piston, or other pressure system. A second delivery catheter, such as a second insemination, IVF, or drug delivery catheter, can be simultaneously inserted into inlet port 40 or a second inlet port. The second delivery catheter can be deployed to target site 164 simultaneously with or after transfer catheter 156.

[0201] The system handle 30 can have an introduction area. For example, the introduction area can be free of steps, edges, protrusions, or restrictions that could obstruct or contact the distal opening of the transfer catheter 156 during passage, such that the transfer catheter 156 can be easily loaded into the system handle 30, for example, when 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, such as to expel reproductive material 166 once the distal end port of the transfer catheter 156 is at the target site 164 (e.g., after the eversion balloon 18 is fully deployed). Actuation of the insemination syringe or pump on the preloaded transfer catheter 156 can be performed by the same hand that holds and operates the components of the eversion catheter system.

[0202] Furthermore, the transfer catheter 156 can be configured to be introduced into the proximal connector in the handle of the eversion catheter system once the system is fully deployed.

[0203] A user may perform any or all of the following operations while using eversion balloon system 2, for example, using a single hand:

[0204] a. Pressurize the eversion catheter system;

[0205] b. The eversion balloon system 2 is placed at the patient's cervix;

[0206] c. Maintain the position of the eversion balloon system 2 throughout the process;

[0207] d. Advancing the inner catheter 8 and the eversion balloon 18;

[0208] e. Once extended beyond the everted balloon membrane 24 or the inner catheter 8, the transfer catheter 156 is presented for deposition into a body cavity, such as the uterine cavity;

[0209] f. retracting the inner catheter 8 and the eversion balloon 18; and / or

[0210] g. Activate (eg, toggle) the pressure release lever to remove or release the hydraulic or pneumatic pressure from the media volume 12 .

[0211] Figures 10A to 10C It is shown that the distal end of the everted balloon can form a balloon check valve 168. The length of the distal end of the everted balloon 18 to the distal end of the inner catheter 8 can be radially collapsed to form a tight orifice, which can be the balloon check valve 168. The balloon check valve 168 can be an openable barrier that can block or interrupt fluid communication between the inner catheter lumen 10 and the target site 164.

[0212] The balloon membrane 6 can have a wall overlap of about 1 mm to about 3 mm at the balloon check valve 168 that closes the inner catheter lumen 10. The strength or closing pressure of the balloon check valve 168 can be adjusted during use. For example, by controlling the amount of deflection that the inner catheter 8 and the everted balloon membrane 24 can make, the overlap distance of the balloon membrane 6 can be increased or decreased.

[0213] Figure 10B It is shown that the distal end of the transfer catheter 156 can be advanced through the inner catheter lumen 10, through the balloon check valve 168, and to the target site 164 as indicated by arrow 170. As the transfer catheter 156 moves through the balloon check valve 168, the transfer catheter 156 can penetrate or push open the balloon check valve 168. When the distal end of the transfer catheter 156 is distal to the balloon check valve 168 and at the target site 164, the reproductive material 166 loaded in 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.

[0214] Figure 10C It is shown that after the reproductive material is deposited 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. As the transfer catheter 156 is advanced 170 therethrough, remains stationary therein, and is retracted through the balloon check valve 168, the balloon check valve 168 can maintain a seal between the inner catheter lumen 10 and the target site 164.

[0215] After deposition of reproductive material 166 is complete, reproductive material 166 can be isolated from vacuum effects caused by vacuum forces generated by retraction of transfer catheter 156 through the system or retraction of reproductive material 166 from target site 164. Balloon check valve 168 can reduce or eliminate the vacuum effects of embryo transfer.

[0216] Balloon check valve 166 can serve as a tactile indicator for the physician when inserting the transfer catheter 156 through the everting balloon system 2. During the transfer procedure, the amount of delivery catheter 156 inserted through the distal end of the everting system can vary from patient to patient, depending on physician preference or patient anatomy. When the distal end of the transfer catheter 156 passes through balloon check valve 168, the resistance created by balloon check valve 168 can be felt by the physician at the proximal end of the transfer catheter 156. The degree or amount of resistance can be adjusted based on the length of the balloon selected as balloon check valve 168. In some procedural settings, the ability to visualize the extent of insertion of the transfer catheter 156 into the everting balloon 18, or the physical depth indicator or marking on the proximal end of the transfer catheter 156, may be impaired. This ability to visualize may be due to low lighting in the operating room, thus enhancing imaging and visualization on a monitor. Furthermore, the physical relationship between the physician, embryologist, and other personnel or equipment in the operating room may affect the ability to easily visualize the extent of insertion of the everting catheter. The tactile sensation of resistance to the balloon check valve 168 may produce a tactile indication that the diversion catheter 156 is at the distal end of the everted balloon 18 .

[0217] The eversion balloon system 2 may be used to access and seal the uterine cavity, such as for the deposition of reproductive material 172 for prolonged intrauterine insemination.

[0218] Figures 11A to 11C It is shown that as the everting balloon 18 is passed through the cervical canal, the everting balloon membrane 24 can form a seal within the cervical canal (eg, against the cervical canal wall 174). Figure 11A It is shown that when the balloon is pressurized and the inner catheter 8 is advanced distally, the everted balloon membrane 24 can be expanded and advanced along the cervical wall as shown by the arrows. The outer catheter 4 can also seal the cervical wall 174. For example, the outer diameter of the outer catheter 4 can be equal to the outer diameter of the everted balloon.

[0219] Figure 11B The transfer catheter 156 is shown as being distally advanced within the everted balloon 18 and the inner catheter lumen 10. The transfer catheter 156 can deposit reproductive material 166 (eg, sperm) within the uterine cavity 176.

[0220] Figure 11C It is shown that the transfer catheter 156 and / or the inner catheter 8 can be retracted (e.g., from 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. The distal opening of the balloon 178 can be closed, for example, due to pressure within the everted balloon 18 forcing the everted balloon 18 to form a balloon check valve 168. The balloon check valve 168 can seal the cervical canal and the uterine cavity 176 from the inner catheter lumen 10. The reproductive material 166 can be retained in the uterine cavity 176 and not expelled through the cervix.

[0221] 12A to 12E An everting catheter for performing an IUD placement procedure is shown. Figure 12A Shown is an external eversion catheter, wherein the IUD contained in the external eversion catheter system 2 is in an inverted membrane position. The external eversion membrane and IUD (not visible in this figure) are contained in the outer catheter 4, with an acorn tip 242 at the distal end. The acorn tip 242 can have an opening (not visible) at the distal end. There is a T-shaped joint or Y-shaped joint 244 at the proximal end of the outer catheter 4, which contains an x-shaped ring gasket (not visible). An extension tube and a stopcock 248 provide inflation energy or hydraulic energy to the external eversion catheter system. The hydraulic energy can be provided by saline, air, a combination of saline and air, or gas (e.g., CO2), contrast agent, culture medium, and other fluids. In operation, the hydraulic energy can be in the range of 2 to 4 atmospheres or 1 to 6 atmospheres. The inner catheter 8 can translate within the outer catheter 4 to advance and retract the external eversion membrane (not visible). There is a proximal hub 246 at the proximal end of the inner catheter 8, which is designed to allow the IUD sutures 252 to pass through. Other embodiments may not require the IUD sutures to be exposed from the inner catheter.

[0222] Figure 12B The distal end of the everted catheter is shown, with an IUD 254 visible in the everted membrane, which is only partially everted from the acorn tip 242. The IUD 254 can be in a folded state within the membrane 6. The IUD sutures 252 can be proximal to the IUD 254. The IUD sutures 252 can be located within the central lumen of the inner catheter 8. The IUD 254 can have a rounded distal end 256 and a shaft 258. The IUD 254 can have features such as a radiopaque marker band 260, a copper or drug or hormone eluting portion 262.

[0223] Figure 12C The advancement of the eversion membrane 6 is shown, pulling the IUD 254 through the distal end of the outer catheter 4 and opening at the acorn tip 242. The membrane's eversion can be performed in response to hydraulic energy or pressure within the eversion catheter system 2, via the inflation tube and stopcock (not shown). The eversion membrane 6 rolls from the inside out in response to the hydraulic energy. Advancement of the eversion membrane 6 can be performed by the user translating the inner catheter (not shown) or automatically in response to the hydraulic energy. The eversion membrane can have dimensions ranging from 1 mm to 5 mm when used in the cervical canal, or an outer diameter of 4.0 mm to 4.5 mm when pressurized to 2 atmospheres. The eversion membrane can have an outer diameter ranging from 2 mm to 7 mm, with a wall thickness of 0.001" to 0.004" or 0.0015". The eversion membrane can be made of irradiated polyolefin, polyurethane, Pebax, silicone, or other flexible membrane materials. Depending on the modulus of the membrane material, the wall thickness of the eversion membrane can range from 0.002" to 0.010".

[0224] Figure 12DThe outer catheter 4 and the distal end of the acorn tip 242 are shown, with the everted membrane 6 in a further stage of eversion to advance the IUD 254 through the distal opening in the acorn tip 242. The rounded end 256 of the IUD 254 is in the initial stages of returning to its natural state, rather than its folded state. In its natural state, the IUD 254 can have a "T" or "Y" shape, although other shapes and configurations are possible.

[0225] Figure 12E The completion of the eversion process is shown, wherein the everted membrane 6 is further extended beyond the acorn tip 242 and fully exposes the IUD 254, which can now be in its natural (i.e., unbiased or mechanically relaxed) state or "T" shape. The rod 258 and the hormone or drug eluting portion 262 are fully exposed from the distal end of the membrane 6. Some IUDs are equipped with a band or ring of copper material as a spermicide. The IUD suture 252 can still be within the central lumen of the membrane 6 and the inner catheter (not visible). When the membrane 6 is fully exposed, the IUD 254 can be at the insertion depth within the uterine cavity. The insertion depth of the IUD 254 within the uterine cavity can be determined or specified by the length of the membrane 6 and the amount of eversion performed by the user during translation of the inner catheter 8, which can vary according to the desired insertion depth. In addition, the outer catheter 4 can be constructed with a telescopic tube (not shown) that can change the membrane length and insertion depth within the uterine cavity.

[0226] 13A to 13I Additional derivatives of the everting catheter system 2 for placement of an IUD are shown. Figure 13A 2. The outer catheter system 2 is shown with an IUD 254 in a folded position within an everted membrane 6 (not visible) within the outer catheter 4. The inner catheter 8 can be adjacent to the Y-junction 244 and continue within the outer catheter 4. The everted 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 tip 242 can be located at the distal end of the outer catheter 4. The everted membrane 6 can be pressurized by a fluid, a gas, or a combination of both via an extension tube and a stopcock 248. Within the inner catheter 8 can be a pusher 264, which can be adjacent to the inner catheter hub 246. The pusher 264 can be a hollow tube with a pusher hub 266 that can contain the IUD suture 252 within its lumen.

[0227] Figure 13BThe acorn tip 242 is shown in side view, with the dotted line indicating a lumen 276 passing through the acorn tip. The acorn tip 242 can be used to position the external cervix of the patient. The acorn tip 242 includes a cannula tip 268 on the rear surface, which can be designed to obtain a grip or cannula into the cervical opening having a rounded surface 269 on the front. The acorn tip 242 can have an external shoulder 270 to provide a stop mechanism to prevent accidental insertion of the external catheter 4 into the patient's cervical canal. The distal opening 272 can be configured to allow the external cervix to deliver an IUD (neither shown).

[0228] Figure 13C and Figure 13D Another type of acorn tip 242 is shown, having a lower profile front surface 274 with an outer shoulder 270 that tapers at the front of the circumference of the acorn tip 242. The lower profile front surface 274 provides the physician with a greater view of the ectocervix when placing an everting catheter (not shown). The physician can use the lower profile front surface to better visualize the ectocervix while maintaining the acorn tip's function of cannulating the ectocervix, increasing grip, and providing a stop mechanism to prevent accidental advancement of the ectocervix into the cervical canal. Optionally, the acorn tip 242 includes a cannula tip 268 on the distal end of its rear surface to facilitate initial placement of the device at the patient's ectocervix, with a ramp 271 leading to the shoulder 270. The dashed line indicates a through lumen 276 with a distal opening 272.

[0229] Returning to the alternative embodiment of the eversion catheter system 2, Figure 13E IUD 254 is shown being advanced through everted membrane 6 in response to advancement of inner catheter 8 within outer catheter 4 using hydraulic energy supplied in extension tube and stopcock 248. In conjunction, pusher 264 can be advanced with everted membrane 6 with two strands of IUD suture 252 exiting pusher hub 266.

[0230] Figure 13F Further advancement of the IUD 254 is shown with the everted membrane 6 and inner catheter 8 translating within the outer catheter 4. Rounded end 256 is exposed distally at the end of the everted membrane 6 as the membrane everts and pulls the IUD forward.

[0231] Figure 13G The IUD 254 is shown released from the eversion membrane 6, wherein the IUD is completely in its natural state or "T" or "Y" shape. The IUD suture 252 can be placed near the IUD and passed through the eversion membrane 6, the pusher 264 and the inner catheter (not visible). To complete the IUD release, the pusher 264 pushes the IUD 254 beyond the distal end of the eversion membrane 6.

[0232] Figure 13H and Figure 13I An alternative embodiment of the distal end of pusher 264 is shown. Figure 13H The distal end of pusher 264 is shown, with a pusher cup 278 having a concave opening 280 to accommodate and retain the contour of the proximal end of IUD 254 (not shown). Pusher 264 can have a through lumen with a central axis 282. Distal pusher cup 278 facilitates handling and loading of IUD 254 within an everting catheter (not shown).

[0233] Figure 13I An alternative form of the distal end of pusher 264 is shown, with pusher 264 having a through lumen and a central axis 282 and a shunt opening 284 at the distal end. Shunt opening 284 can be configured to open and receive and retain the proximal end (not shown) of IUD 254. Distal shunt opening 284 facilitates handling and loading of IUD 254 within an eversion catheter (not shown).

[0234] Figure 14A and Figure 14D Advancement of the IUD 254 within the everted membrane 6 from the folded condition to the release of the IUD 254 and its return to its natural condition or "T" shape is shown. Figure 14A The everted membrane 6 advanced through the acorn tip 242 is shown pulling the IUD 254 in a collapsed, low-profile state within the everted catheter system 2. The rounded end 256 is compressed by the everted membrane 6 in response to hydraulic energy supplied through the extension tube and stopcock (not visible).

[0235] Figure 14B and Figure 14C Further shown is the advancement of the IUD 254 within the everted membrane 6 within the everting catheter system 2. As the IUD 254 is pulled forward by the everted membrane, the IUD 254 may return to its natural state or "T" or "Y" shape. Figure 14B The eversion membrane 6 is shown in a pressurized state via hydraulic energy. The IUD suture 252 can be contained within the distal end of the pusher 264 within the split opening 284.

[0236] Figure 14D Another embodiment of the eversion catheter system 2 is shown in which the hydraulic energy can be removed by a pressure source 286 via an extension tube and stopcock 248. Once the hydraulic energy is removed from the eversion catheter system 2, the eversion membrane 6 can no longer clamp the IUD 254 and the pusher 264 can advance the proximal end of the IUD beyond the distal opening of the eversion membrane. The pressure source 286 can be an inflation device as shown or other device, such as a syringe, a syringe and compliant tubing, a pump, or a pressurized canister or container.

[0237] Figure 15AAn external catheter system 2 is shown equipped with a one-handed delivery mechanism. At the proximal end of the external catheter system 2, the housing 288 can be configured with a roller 290 and an external catheter release button 292. At the distal end, the acorn tip 242 can be designed to engage the ectocervical canal when placed in the patient for IUD delivery and placement. The IUD 254 is visible within the external catheter 4. The extension tube and stopcock 248 can be located at the rear of the housing 288. From the proximal portion of the housing 288, the pusher 264 and pusher hub 266 can be visible through the IUD suture 252 protruding through the lumen of the pusher 264.

[0238] Figure 15B The eversion catheter system 2 is shown with a one-handed operation mechanism using the housing 288. The operator's thumb can be placed on the roller 290, with the outer catheter release button 292 very close. The IUD 254 is visible within the outer catheter 4 and the pusher 264, with the pusher hub 266 visible emerging from the proximal portion of the housing.

[0239] Figure 15C A top view of the one-hand mechanism of the eversion catheter system 2 is shown, with the inner catheter 8 visible within the housing 288. Also visible is the inner catheter hub 246, with the pusher 264 protruding from the proximal portion of the inner catheter hub. The IUD suture 252 is visible protruding from the proximal opening of the pusher hub 266. Within the housing 288, the pusher stop 294 and the gear housing 296 are also visible under the operator's thumb.

[0240] Figure 15D The top view further illustrates the one-handed operation of the eversion catheter system 2 during advancement of the eversion membrane 6, pulling the IUD 254 through the acorn tip 242. A roller 290 (partially visible beneath the operator's thumb) can be used to advance the inner catheter 8, allowing advancement of the eversion membrane. Advancement of the eversion membrane 6 can be limited when the inner catheter hub 246 reaches the gear housing 296. When the inner catheter 8 can be advanced into the outer catheter 4, the inner catheter hub 246 reaches the gear housing 296 and advances the pusher 264 until the pusher hub 266 mechanically engages the pusher stop 294. In operation, the operator actuates the outer catheter release button 292, which allows the outer catheter 4 and attached eversion membrane 6 to retract, while the pusher 264 is held in place relative to the housing 288 by the pusher stop 294. Consequently, the distal end of the pusher 264 advances the IUD 254 beyond the distal end of the eversion membrane 6 and releases the IUD 254 within the uterine cavity. In operation, the operator will remove the entire eversion catheter system 2 and pass the IUD suture 252 out of the pusher 264.

[0241] Figures 16A to 16JAnother embodiment of an everting catheter system 2 is shown with a handle 30. Protruding from the distal end of the handle 600 may be the outer catheter 4, and protruding from the proximal end of the handle may be the pusher 264, with the IUD suture 252 exiting the pusher hub 266. On the front of the handle 600 may be the inner catheter button 298 and the outer catheter release button 292. Protruding from the rear of the handle 600 may be the extension tube and stopcock 248 (partially visible).

[0242] Figure 16B The inner catheter button 298 is shown advanced within the housing slot 308 on the front surface of the housing 288. The inner catheter button 298 is attached to the proximal end of the inner catheter (not shown) and its advancement translates the inner catheter and eversion membrane to deliver the IUD (not shown). In operation, the inner catheter button 298 is advanced until it engages the outer catheter release button 292, which is also on the front surface of the housing 288.

[0243] Figure 16C Retraction of the outer catheter release button 292 is shown, which effects release of the IUD from the everted catheter (not shown).

[0244] Figure 16D Information is provided regarding how the housing 288 works with the eversion catheter system 2 to perform advancement and release of an IUD (not shown). Figure 16D , the front of the housing 288 is removed, showing the interior of the eversion catheter system 2 including the inner catheter hub 246. Optionally, the inner catheter hub 246 can be eliminated by the inner catheter button 298 or have two devices as shown. Also visible are the pusher 264 and the pusher hub 266, where the IUD suture 252 exits the proximal portion of the pusher hub. The outer catheter release button 292 and the inner catheter button 298 are also visible, and in this position, the advancement of the eversion membrane (not shown) is completed. Contained within the rear portion of the housing 288 are the inflation tube slots 300 and the pusher engagement tabs 302, which are configured to mechanically retain the pusher hub 266 when the eversion step is completed. Also visible are the housing apertures 304, which are designed to snap onto the front and rear portions of the housing 288.

[0245] Figure 16E A cross-sectional view of the proximal portion of the Y-connector 244 is shown, with the inner catheter 8 exiting the proximal end of the Y-connector. Extension tubing and stopcock 248 (stopcock not shown) exit rearward from the Y-connector 244 and pass through the housing 288 via the inflation tube slot 300. The outer tube release button 292 is mechanically attached to the Y-connector 244 and can be retracted into the housing 288 along the inflation tube slot 300.

[0246] Figure 16FAnother cross-sectional view shows the gas tube slot 300 on the rear surface of the housing 288. The extension tube and the tap 248 (the tap is not shown) are visible in the gas tube slot 300.

[0247] Figure 16G A cross-sectional view of the proximal portion of the housing 288 and the proximal aperture 306 is shown. The pusher 264 is visible emerging from the proximal portion of the inner catheter hub 246. The inner track of the pusher engagement tab 302 is visible on the inner rear surface of the housing 288, which gradually narrows as it extends from the proximal portion to the distal portion of the housing 288. The pusher hub 266 may have a tapered or tapered profile on its distal portion to pass through the pusher engagement tab 302. Once the pusher hub 266 extends beyond the pusher engagement tab 302, the flat proximal portion of the pusher hub 266 may act as a mechanical detent in the proximal direction.

[0248] Figure 16H Another cross-sectional view through the right-hand side of the housing 288 shows the initial steps of IUD delivery and placement, with the outer catheter 4 distal to the Y-connector 244 and attached to the outer catheter release button 292. Additionally, on the front surface of the housing and within the housing slot 308 is the inner catheter button 298. Exiting the proximal end of the inner catheter 8 and the inner catheter button is the pusher 264. Attached to the proximal end of the pusher 264 is the pusher hub 266, which has a lumen for the IUD sutures 252.

[0249] Figure 16I The same cross-sectional view shows the range of advancement of the inner catheter button 298 during the eversion step, wherein the eversion catheter system 2 is hydraulically pressurized via the extension tube and stopcock 248 (stopcock not shown). This embodiment shows the inner catheter 8 advanced 12.6 cm within the outer catheter 4. This advancement distance corresponds to an insertion depth of 6.3 cm within the uterine cavity. Other advancement lengths of 3 cm to 24 cm are possible. In addition, the physician can control the insertion depth by stopping the eversion step at any time during the process.

[0250] Figure 16J The release step of the IUD delivery process through the everted catheter system 2 is shown, wherein the outer catheter release button 292 is retracted, allowing the pusher 264 to pass through the inner catheter 8 to advance the IUD (not shown) through the everted membrane (not shown).

[0251] 17A to 17I Other embodiments of everting catheters for delivering IUDs are shown. Figure 17AAn external cervix catheter system 2 is shown having a housing 288 with a pusher 264 and a pusher luer connector 310 exiting the proximal end of the housing. The pusher luer connector 310 is configured to receive a syringe 74 or other irrigation source to provide fluid, saline, contrast media, ultrasound media, drugs or therapeutic agents, or gas or air through the central lumen of the external cervix catheter system 2. The irrigation fluid or media can facilitate visualization of the external cervix or uterine cavity via ultrasound or fluoroscopy.

[0252] Figure 17B The eversion catheter system 2 is shown in the initial stages of the eversion process, with the front portion of the outer shell 288 removed to identify the internal components and mechanisms.

[0253] Figure 17C The everting catheter system 2 is shown with hydraulic energy supplied through 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 exits the distal end of the acorn tip 242 and pulls the IUD (not shown) and pusher 264 through the central lumen of the everting catheter system 2. The pusher luer 310 translates through the proximal aperture 306 of the housing 288 and into the track of the pusher engagement tab 302.

[0254] Figure 17D The next step in the eversion process is shown where the inner catheter button 298 engages the outer catheter release button 292 and the pusher luer 310 reaches the mechanical detent of the pusher engagement tab 302.

[0255] Figure 17E The next step in the IUD delivery process is shown, where a syringe 74 is connected to the extension tube and stopcock 248 to draw negative pressure within the everting catheter system 2. The negative pressure draws back hydraulic energy in the everting membrane 6.

[0256] Figure 17F The next step in the IUD delivery process is shown in which the outer catheter release button 292 is retracted and thereby retracts the outer catheter 4, eversion 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 luer 310 from retracting and thereby maintaining its position relative to the housing 288.

[0257] Figure 17G A close up view of the distal end of the everted membrane 6 is shown with hydraulic energy removed from the everted catheter system 2 and the distal end of the pusher 264 extending beyond the distal opening of the everted membrane 6. The shunt opening 284 is at the distal end of the pusher 264 and shows that the distal end of the pusher 264 can exit the everted membrane 6.

[0258] Figure 17HAnother type of syringe 74 is shown in which the plunger spring 314 is on the plunger 76. The engagement button 312 can translate within the syringe housing 208 to lock onto ridges 316 at various locations on the plunger 76. When pressed, the engagement button 312 can lock the plunger spring 314 in a compressed state.

[0259] Figure 17I The syringe 74 is shown with the engagement button 312 released, allowing the plunger spring 314 to expand and retract the plunger 76 to provide negative pressure within the syringe 74 and everting catheter system 2 (not shown).

[0260] 18A to 18C Another embodiment of an everting catheter system 2 is shown that automatically provides negative pressure to remove hydraulic energy in the everting catheter during the step of releasing the IUD (not shown) during the delivery and placement process. Figure 18A The eversion catheter system 2 is shown with a housing 288 and a syringe 74 mounted or attached to the bottom rear surface of the housing. The syringe 74 can compress the plunger spring 314 and lock the engagement button 312 in 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.

[0261] Figure 18B Advancement of the inner catheter button 298 is shown within the outer housing slot 308. Advancement of the inner catheter button 298 translates the inner catheter (not shown) within the outer catheter 4 and advances the eversion membrane and IUD (neither shown).

[0262] Figure 18C The next step in the IUD delivery and placement process is shown. Depression of the outer catheter release button 292 forces the engagement button 312 to release the plunger spring 314 and plunger 76, thereby generating negative pressure in the everted catheter system 2 via the inflation tube 318. At this point, the outer catheter release button can be retracted along the housing slot 308 to retract the outer catheter 4, the everted membrane, and the inner catheter (not shown), while maintaining the position of the pusher (not shown) and releasing the IUD (not shown) from the everted membrane (not shown).

[0263] Figure 19AAn inverted IUD (IUD) delivery catheter system 2 is shown. An IUD 254 can be loaded in a collapsed state within a balloon membrane (not visible) and an inner catheter 8. The inner catheter 8 can be within an outer catheter 4. At the distal end of the outer catheter 4, a movable flange can be provided with an insertion depth indicator 402. A T-junction 244 is located at the proximal end of the outer catheter 4, which is used to pressurize the inverted balloon via an x-ring valve (not shown) to translate the inner catheter 8. The inner catheter 8 has a proximal hub 246, which can be a luer, 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 the IUD suture 252. Pressurization of the inverted catheter system 2 can be performed using a syringe 410 and syringe plunger 409, which can be connected by the user or physician to a connector 413, which can be connected to a compliant tube 412. The clamp 411 can be used by the user or physician to close the compliant tube 412 to maintain pressure within the everting balloon.Once pressurized, the syringe 410 can be disconnected from the everting catheter system 2 and removed from the everting catheter system 2 before insertion into the patient.

[0264] Figures 19B to 19D is a close-up view of the different parts of the eversion catheter system 2. Figure 19B 4 is a close-up view of the distal end of the outer catheter 4, wherein the initial portion of the everted balloon 6 is visible before exiting the distal end of the outer catheter 4. The distal opening of the outer catheter 4 may have an acorn tip or no acorn tip and a smooth, rounded, low-profile distal tip. The distal end may have an indicator 402, such as markings of 7 cm, 8 cm, 9 cm, and 10 cm, to indicate the insertion depth to the user (e.g., a physician). A removable flange 401 may be positioned by the user (e.g., a physician) to provide a visible and tactile indicator of the insertion depth. The IUD 254, visible within the outer catheter 4, is in a folded, loaded, low-profile state within the everted balloon and inner catheter (not visible).

[0265] Figure 19CFigure 4 is a close-up view of the pressurization system of 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 media. Depression of the syringe plunger 409 by the user or physician provides hydraulic energy to the eversion balloon. Syringe 409 can have a volume of 1cc, 3cc, 5cc, or 10cc, for example, 3cc as shown. Other volumes are possible. Pressurization of the eversion catheter system 2 can inflate a compliant tube 412. The compliant tube 412 can be made of silicone and / or other elastomeric materials (e.g., polyurethane, rubber, TPE, or a combination thereof). During inversion and eversion, the compliant tube 412 can maintain a near-constant pressure within the eversion catheter system 2. The compliant tube 412 can mitigate situations in which the user or physician inadvertently applies excessive pressure within the eversion catheter system 2, as the silicone tube can continue to expand in response to increasing hydraulic pressure. The amount of pressurization can be from 1 to 4 atmospheres, with 2 atmospheres being the nominal level. The degree of compliance within the silicone tubing can depend on the hardness of the material, the wall thickness of the tubing, and the length of tubing available for expansion. For example, as shown, the compliant tubing 412 can be silicone with a hardness of 50A, a length of 6 cm, an outer diameter of 4.75 mm, and a wall thickness of 1 mm. Once pressurized by the syringe 410, the pressurization system can be closed by the user using clamps 411, for example, to close the lumen of the compliant tubing 412. Other tubing closure devices can be used, such as stopcocks, gate valves, roller clamps, or combinations thereof. A one-way check valve or Luer-activated valve can be used on the compliant tubing 412 in place of or in combination with the connector 413 to allow one-way pressurization without the user having to actuate a closure device to close and maintain pressure within the compliant tubing 412 and the eversion catheter system 2. The hydraulic pressure provided by the syringe 410 and the syringe plunger 409 can be fluidically connected to the eversion catheter system 2 through a T-junction 244 having an x-ring valve (not shown) to maintain pressure and translation of the inner catheter 8 within the outer catheter 4 during balloon membrane eversion. The inner catheter 8 can be made of nylon, Pebax, polypropylene, polyethylene, or a combination thereof. The inner catheter 8 can extend from the distal end of the fully everted balloon to the proximal end of the T-junction 244, which has an outer diameter of 4 mm and an inner diameter of 3 mm.

[0266] Figure 19DFIG2 is a close-up view of the proximal portion of the outward-turning catheter system 2, showing an inner catheter 8 having a proximal connector hub 246 with a central through-hole. Within the central through-hole can be a pusher 264 with a pusher hub 266 having a central through-hole with an IUD suture 252. The proximal ends of the connector hub 246 and the pusher hub 266 can be Luer connectors to allow for connection of a syringe or tubing for injecting fluids, saline, or gaseous media, thereby dilating the uterine cavity for ultrasound, fluoroscopy, or endoscopic visualization. The proximal ends of the connector hub 246 and the pusher hub 266 can be handles or knobs that the user or physician uses to manipulate the catheter. Pusher 264 can be made of nylon, Pebax, polypropylene, polyethylene, or a combination thereof. The pusher 264 tube can have an outer diameter of 2 mm and an inner diameter of 1.25 mm, and can be approximately the entire length of the outward-turning catheter system 2, for example, to allow the user or physician to expel the IUD from the inner catheter 8 during placement within the uterine cavity.

[0267] Figure 20A The eversion catheter system 2 is shown after the balloon is fully everted during the delivery of an IUD. The IUD 254 can be in a folded, loaded state within the inner catheter 8 and the everting balloon 6. The outer catheter 4 can include an indicator marker 402 and a depth insertion marker flange 401. The outer catheter 4 can be connected to a t-junction 244 having an x-ring valve (not shown) and can be connected to a compliant tube 412 via a Luer connector 413 and a tube clamp 411 for hydraulic pressurization of the eversion catheter system 2. Immediately adjacent to the t-junction 244 can be a proximal connector hub 248, indicating full eversion of the everting balloon and full translation of the inner catheter (not visible). Near the proximal connector hub 248 are the pusher 264 and pusher hub 266. Near the pusher hub 266 can be the IUD suture 252, which is seen outside the central lumen of the tube.

[0268] Figure 20B2 is a close-up view of the distal end of the everted 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 everted balloon 6, and the rounded distal end 256 of the IUD 254 can be placed against the fully everted balloon 6. Visible through the everted balloon 6 and the inner catheter is a portion of the IUD 254, including the copper wire 271, the IUD shaft hole 272, the suture knot 273, and the IUD suture (not visible). The everted balloon 6 can be connected to the outer catheter 4 by an indicator mark 402. For example, the everted balloon 6 can be 6 cm long to pass through the length of the cervix and the length from the exocervix to the endocervical os can be 3.5 cm. Different lengths of everted balloon 6 can be used to approximate the length of the uterus of different patients. For example, the eversion balloon can have an outer diameter of 4 mm and a wall thickness of 0.0015 thousandths of an inch when pressurized at 2 atmospheres. The eversion balloon can be made of irradiated polyolefin, polyethylene, Pebax, polyurethane, other biocompatible materials that can produce a hydraulic eversion balloon, or combinations thereof.

[0269] The distal end of the inner catheter (not visible) can have an inner diameter that can, for example, allow a folded IUD to fit within the tube. For example, an inner diameter of 3 mm can allow a folded IUD to fit within the tube while maintaining a rounded distal end 256 protruding toward the distal end of the inner catheter (not visible) and the outward-facing balloon 6. The distal end of the pusher (not visible) can be proximate to the IUD shaft hole 272 and the suture knot 273. The distal opening of the outward-facing balloon 6 can be connected to the distal end of the inner catheter (not visible). When inverted and pressurized, the outward-facing balloon 6 can fold the IUD 254 into a lower profile that facilitates advancement through the cervical canal and into the uterine cavity. When inverted and pressurized, the outward-facing balloon 6 can fold and compress the rounded distal end 256 together into a low profile, for example, to facilitate advancement through the outward-facing catheter system 2, the distal opening of the outer catheter 4, and the cervical canal and into the uterine cavity.

[0270] Figure 20C 2 is a close-up view of the proximal portion of the eversion catheter system 2 after full eversion during delivery of an IUD 254. The outer catheter 4 can be connected to a t-junction 244 having an x-ring (not visible) and fluidly coupled to a compliant tube 412, with the tube clamp 411 shown in a closed position, with the eversion catheter system 2 hydraulically pressurized. The proximal end of the connector hub 248 can be seen proximal to the t-junction 244, e.g., indicating full eversion of the eversion balloon (not shown) and full translation of the inner catheter (not visible). Within the proximal end of the connector hub 248 can be a pusher 264, with a pusher hub 266 at the proximal end of the pusher 264. The IUD suture 252 can be seen exiting the central lumen through the pusher 264.

[0271] Figures 21A to 21CThe process of delivering an IUD is shown within a simulated uterine cavity model 500 (which, for illustrative purposes, replaces a patient's uterine cavity and other corresponding anatomical structures), with a metric scale 510 provided for reference. Figure 21A The placement of an IUD 254 within a simulated uterine cavity model 500 is shown, wherein the uterine cavity model 500 has a base portion 501 simulating the cranial vault of the uterine cavity, as well as horns 502 (representing the patient's right fallopian tube ostium) and 503 (representing the patient's left fallopian tube ostium). The simulated uterine cavity model can include a lower uterine segment 504 with a simulated cervical canal 505 and a simulated ectocervical canal 506. The eversion catheter system 2 can have a fully everted everted balloon 6, with the rounded distal end 256 of the IUD 254 proximal to the fundus 501 of the uterine cavity and distal to the everted balloon 6. The pusher 264 can be positioned proximal to the IUD 254. The flange 401 can abut the ectocervix 506, for example, at an insertion depth of approximately 9 cm.

[0272] Figure 21B The next (e.g., intermediate) step in the process of placing an IUD using the eversion catheter system 2 is shown. The eversion catheter system 2 can be retracted 1.5 cm, and is now, for example, 1.5 cm from the exocervix 506 as viewed from the flange 401. In combination, the IUD 254 can be expelled from the distal end of the eversion balloon 6 by the pusher 264 and the retraction of the eversion catheter system 2. The IUD 254 can have a rounded distal end 256 that flares outward toward the corner regions 502 and 503.

[0273] Figure 21C The next (e.g., final) step of IUD 254 placement using an external eversion catheter system (not shown) is shown, wherein the external eversion catheter system can be completely removed from the simulated uterine cavity model 500. The rounded distal end 256 can remain in the corner regions 502 and 503. The IUD suture 252 can be visible from the ectocervical canal 506. The user or physician can trim the excess length of the IUD suture 252 depending on the amount of excess IUD suture or the type of IUD.

[0274] Figures 22A to 22EA packaging configuration for transporting and loading an inflatable catheter system 2 for delivering an IUD is shown. The inflatable catheter system 2 can be placed on a pouch card 600 in a fully inflated position, with the IUD 254 positioned distal to the inflated balloon (not visible). The pouch card 600 and inflatable catheter system 2 can be placed in a sealed bag (not shown) for sterilization, transport, and ultimately, use by a physician. The pouch card 600 can be made of clear laminated paper stock, PETG, polypropylene, polyvinyl chloride, PET, or a combination thereof. Affixed to the pouch card 600 can be a protective tube 601, which can be, for example, 6.5 cm long and 4 mm in inner diameter. The length of the protective tube 601 can be determined to accommodate the fully inflated balloon (not visible) and to position the IUD 254 in an open configuration, with the rounded distal end 256 extending beyond the distal end of the protective tube 601. The inner diameter of the protective tube 601 can be determined to allow a non-pressurized inflated balloon (not visible) to slide through the central lumen. 602 . The outer diameter of the everting balloon can contact the lumen of the protective tube 601 when the everting balloon (not visible) is pressurized. For example, contacting the lumen when pressurized can allow a user or physician to easily retract the everting balloon and inner catheter for loading and preparation for use. The protective tube 601 can be made of nylon, but can also be made of polypropylene, PET, Pebax and other tubing used for medical device packaging. The T-junction 244 and the proximal connector hub (not visible) can be held in place by the bag tab 602, with the inner catheter (not visible) fully translated into the outer catheter 4. The pusher 264, pusher hub 266 and IUD suture 252 can extend to the proximal end of the everting catheter system 2.

[0275] Figure 22B 6 is a close-up view of a variant of the distal portion of the pouch card 600 and the protective tube 601, wherein the everting balloon (not visible) is fully everted within the protective tube 601. The IUD 254 can be in an open configuration and can be located at the distal end of the everting catheter system 2, with the IUD sutures (not visible in this view) running the entire length of the inner catheter and pusher of the everting catheter system 2. The proximal end of the protective tube 601 can be cannulated by the distal end of the outer catheter 4.

[0276] Figure 22C The steps in the preparation of the eversion catheter system 2 (e.g., unpacking, assembly, and pressurization) are shown. The bag 603 can be peeled back in half to expose the proximal portion of the bag card 600. The user or physician can connect the syringe 410 to the compliant tube 412 with the clamp 411 in the open position. The compliant tube can be rotated upward or perpendicular to the surface or bag card 600. The eversion catheter system can be pressurized with 3cc of saline.

[0277] Figure 22DThe compliant tube 412, pressurized with the clamp 411, is shown in a closed position with the syringe disconnected and removed from the luer connector 413. The IUD suture 252 can then be pulled to retract the IUD 254 into the distal end of the inner catheter (not visible) within the protective tube 601.

[0278] Figure 22E is a close-up view of the distal portion of the pouch card 600 with the IUD 254, which can be in a collapsed and loaded configuration within an inner catheter (not visible) within a protective tube 601. The everting balloon (not visible) can then be fully inverted using the inner catheter (not visible), which can be fully translated rearward, e.g., to remove the everting catheter system 2 from the protective tube 601 and pouch 603 in preparation for insertion into a patient.

[0279] Any element described herein as a singular can be in plural form (that is, any element described as "a" can be more than one). Any species element of the genus element can have the features or elements of any other species element of the genus. The medium conveyed herein can be any fluid described herein (e.g., liquid, gas, or a combination thereof). The patents and patent applications cited herein are all incorporated herein by reference. For reasons of clarity, some elements may be missing from individual figures. The above-mentioned configurations, elements, or complete components and methods and their elements for performing the present disclosure, as well as variations of aspects of the present disclosure, can be combined and modified with each other in any combination. All devices, equipment, systems, and methods described herein can be used for medical (e.g., diagnosis, treatment, or rehabilitation) or non-medical purposes.

[0280] U.S. Patent Nos. 9,028,401, published on May 12, 2015, 9,101,391, published on August 11, 2015, and 10,034,986, published on July 31, 2018, and U.S. Patent Nos. 2019 / 0009058, published on January 10, 2019, 2020 / 0206463, published on July 2, 2020, 202 / 0297384, published on September 24, 2020, and 2020 / 0023162, published on January 23, 2020, are all incorporated herein by reference.

[0281] Any element described herein as a singular may be in plural form (i.e., any element described as "a" may be more than one). Any species element of a genus element may have the features or elements of any other species element of that genus. "Dilation" and "dilatation" are used interchangeably herein. The medium 155 conveyed herein may be any fluid described herein (e.g., liquid, gas, or a combination thereof). All patents and patent applications cited herein are incorporated herein by reference. For reasons of clarity, some elements may be missing from individual figures. The above-mentioned configurations, elements, or complete assemblies and methods for performing the present disclosure and their elements, as well as variations of aspects of the present disclosure, may be combined and modified with each other in any combination. All devices, equipment, systems, and methods described herein may be used for medical (e.g., diagnosis, treatment, or rehabilitation) or non-medical purposes.

Claims

1. A system for delivering a device into the female reproductive tract, comprising: a first catheter having a lumen and a distal lumen port, wherein the first catheter has a retracted configuration and an extended configuration; a second catheter positioned within the first catheter, wherein the second catheter has a retracted configuration and an extended configuration; an everted membrane, wherein a first end of the everted membrane is attached to the distal end of the second catheter and a second end of the everted membrane is attached to the distal end of the first catheter, wherein at least a section of the everted membrane extends beyond the distal end of the first catheter when the second catheter is in the expanded configuration; a pusher positioned in the second catheter, wherein a distal end of the pusher is adapted to receive and retain a proximal end of an IUD, wherein in the first catheter, the IUD is in a folded state within the everted membrane, wherein in response to advancement of the second catheter within the first catheter, the IUD is advanced through the everted membrane, and wherein the IUD is released from the first catheter when the pusher advances the IUD beyond the distal end of the everted membrane.

2. The system of claim 1, wherein the system is configured to release the IUD while simultaneously delivering negative pressure within the everted membrane.

3. The system of claim 1, wherein the propeller comprises a connection hub.

4. The system according to claim 1, wherein: The impeller includes an irrigation source.

5. The system of claim 1, further comprising an irrigant, wherein the system is configured to deliver the irrigant through the first catheter while simultaneously releasing the IUD from the first catheter. 6 . The system of claim 1 , further comprising an irrigation source configured to deliver an irrigation agent through the first conduit.

7. The system of claim 1, wherein the system is configured such that when the IUD is released from the first catheter while negative pressure is delivered within the everted membrane, the pusher extends the IUD.

8. A system for delivering a device into the female reproductive tract, comprising: a first catheter having a lumen and a distal lumen port, wherein the first catheter has a retracted configuration and an extended configuration; a second catheter positioned within the first catheter and having a retracted configuration and an extended configuration; an everted membrane attached to the first catheter, wherein the second catheter is translatable within the first catheter to advance and retract the everted membrane, and wherein at least a segment of the everted membrane extends beyond a distal end of the first catheter when the second catheter is in the expanded configuration; an IUD positioned within the first catheter, the IUD being in a folded state within the everted membrane, wherein upon advancement of the everted membrane, the IUD is pulled through the distal end of the first catheter, wherein when the everted membrane is further advanced beyond the distal end of the first catheter, the IUD is released and fully exposed.

9. The system of claim 8, wherein the system is configured to release the IUD while simultaneously delivering negative pressure within the everted membrane.

10. The system of claim 8, further comprising an irrigant, wherein the system is configured to deliver the irrigant through the first catheter while simultaneously releasing the IUD from the first catheter.

11. The system of claim 8, further comprising an irrigation source configured to deliver an irrigation agent through the first conduit.

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