Devices and methods used to guide or assist the insertion of elongated medical instruments into anatomical orifices

Abstract

A device for guiding or assisting the insertion of an elongated medical instrument (18) into an anatomical orifice in a human or animal. The medical instrument may comprise a catheter (18), which is held by a manual control body (21) having a hand connection portion (22) and an instrument connection portion (23). The hand connection portion (22) is connected to an operator's hand, and the instrument connection portion (23) substantially holds the catheter (18) and moves with the hand connection portion. Once in position, an extension and restraint mechanism, such as a sliding mechanism in one form, allows the catheter to extend and deploy a predetermined distance.

Description

[Technical Field]

[0001] The present invention relates to devices and methods for guiding or assisting the insertion of elongated medical instruments into anatomical orifices.

[0002] As used throughout this specification, the term "medical device" refers to catheters, balloons, and other tubes, wires, rods, threads, or similar elongated medical devices that are used for insertion into anatomical openings in the human and animal body, or parts thereof, whether in vivo, ex vivo, post-mortem, or in vitro, whether the anatomical opening is natural, surgically, or otherwise created.

[0003] The present invention has been developed primarily for use in obstetrics and gynecology, and will be described below with reference to these applications, although it will be understood that the invention is not limited to this particular field of use and may also be used in other medical, veterinary, forensic, scientific, or healthcare applications. [Background technology]

[0004] There are many clinical procedures that require the insertion of elongated medical instruments, which are tubular or wire-like objects, into anatomical openings, which can cause discomfort to the patient. Examples of such procedures include: a) Urethral catheterization, performed through the urethra to drain urine from the bladder in patients who have limited mobility or experience urinary problems; b) Embryo transfer in in vitro fertilization (IVF); c) Bakri® balloon / balloon tamponade insertion for the management of postpartum hemorrhage (PPH); d) Tubal patency / patency testing during hysterosalpingography (HyCoSy) or hysterosalpingography (HSG); or e) fetal scalp electrode (FSE) insertion; f) Intrauterine pressure catheter (IUPC) insertion to monitor uterine contractions during labor; g) Intrauterine insemination (IUI) for artificial insemination; or h) Mechanical induction of labor (IOL), in which labor is induced by inserting a balloon catheter through the vagina into the cervix and / or uterus.

[0005] Specifically for mechanical IOL procedures, there are two common techniques for inserting the balloon into the cervix: digital insertion; or speculum insertion.

[0006] In the former technique, the surgeon performs an intravaginal examination to identify the external cervical os. The surgeon then inserts the balloon into the cervix along with a gloved finger. This method involves rough insertion into the desired anatomical region, requiring manual control and manipulation while guiding the catheter to the desired location.

[0007] In the second technique, a spreader is used to maintain the vaginal canal in a dilated state, and the surgeon uses forceps to guide the balloon to the desired anatomical region under direct visualization of the cervix. However, spreader insertion is associated with longer procedure times and is less well tolerated than digital insertion. While the success rates are similar, digital insertion requires fewer instruments and consumables, making it the preferred technique for experienced practitioners. However, there is currently room for improvement.

[0008] In the current clinical workflow for digital insertion, patients are escorted to the delivery room where the procedure will be performed, as shown in Figure 1. The cervix is ​​assessed to calculate the Bishop score, a formula used to predict cervical ripeness and assess the need for vaginal delivery.

[0009] The surgeon then cleanses the cervix with antiseptic solution and prepares the balloon catheter and syringe of water. The surgeon performs an intravaginal examination to locate the external cervical os. The surgeon then inserts the balloon into the cervix along with a gloved finger. The mechanical IOL procedure is completed by confirming that the inflated balloon catheter is placed in the desired anatomical region and taping the outer end of the catheter to the patient's exterior.

[0010] One similar device has been identified to date, described in U.S. Patent Application Publication No. 2021 / 0275100A1. This is a two-clip manipulator that connects to a sheath to allow placement within the cervix, allowing a catheter to be inserted through the sheath and positioned within the uterus. In various embodiments of the invention, the manipulator is attached to or permanently connected to the sheath. In various embodiments of the invention, the sheath has an opening that allows the catheter to be separated from the sheath. In various embodiments of the invention, the manipulator allows the sheath to be positioned within the cervical canal, allowing for monitoring of intrauterine pressure via a catheter and cervical ripening with a balloon catheter.

[0011] Known applicators have inherent problems, such as the ability of a long medical instrument to easily slip through the sheath and protrude beyond the hand during digital insertion. This means the long medical instrument is unprotected and can easily become deformed or misdirected, potentially resulting in damage. Additionally, the small diameter tip can pose a dangerous puncture and potentially damage an internal cavity.

[0012] The prior art appears to have the following significant drawbacks: i) Difficulty in feeding the catheter through the external cervical os or anatomical opening of the cervix; ii) The device may easily get out of control within the vagina; or iii) small parts falling into the vagina; iv) patient discomfort or pain due to the use of plastic parts; v) Risk of damage to the catheter, resulting in impaired inflation or unintended deflation; vi) significant changes to clinical workflow; vii) Injury or patient discomfort due to lack of catheter insertion control by an inexperienced user; viii) The risk of retaining foreign objects due to easily separable designs; and ix) Increase in medical waste.

[0013] Accordingly, prior art devices and methods for guiding or assisting the insertion of catheters, balloons, other tubes, wires, rods, threads, or similar structures into anatomical orifices in humans and animals are considered to have the following problems: a) Inaccuracy in use; b) Facilitating problems for inexperienced or poorly trained users; c) bulky construction; d) Damage to medical devices due to uncontrolled insertion; e) Injury or discomfort due to uncontrolled insertion; f) discomfort caused by the material; g) dislodgment of the appliance; h) Difficulty in use.

[0014] The present invention seeks to provide devices and methods for guiding or assisting the insertion of catheters, balloons, other tubes, wires, rods, threads, or similar elongated medical structures into anatomical orifices in humans and animals, thereby overcoming or substantially ameliorating one or more of the disadvantages of the prior art, or at least providing an alternative.

[0015] Where any prior art information is referred to herein, it should be understood that such reference does not constitute an admission that the information constitutes common general knowledge in the art, or that it does so in Australia or any other country. Summary of the Invention

[0016] According to a first aspect of the present invention there is provided an apparatus for guiding or assisting the insertion of elongated medical instruments into anatomical orifices in humans and animals, the apparatus comprising: a) a manual control body having a holding portion for operation; b) a hand connection portion connectable to the manual control body and used to guide or assist the insertion of elongated medical instruments; c) an instrument connector connectable to the manual control body for connecting a medical instrument intended to guide or assist its insertion into an anatomical opening in humans and animals; i) the instrument connection further comprises a release mechanism; ii) advancing a long medical instrument; iii) allowing for the removal of medical devices from the body; This allows the medical instrument, during use, to extend along at least a portion of the user's fingers, allowing manual guidance of the elongated medical instrument into the anatomical opening, further advancement, and then withdrawal by the user's hand.

[0017] The present invention may enable: (1) Orienting and wearing an elongated medical device along the user's hand; (2) Partial insertion or alignment into an anatomical orifice of a person or animal; (3) Advancement for insertion of long medical instruments; (4) Releasing the medical instrument from the user's hand and allowing the user's hand to be withdrawn while leaving the medical instrument in place.

[0018] One aspect of the present invention is for use with mechanical IOLs in humans. In one form of the invention for mechanical IOLs, the device fits into existing clinical workflows while increasing operator proficiency and reducing procedural complexity, facilitating the transition to digital insertion techniques.

[0019] This is accomplished by attaching the catheter to the finger with a wearable sleeve that ensures intimate contact between the operator's finger and the catheter and contains a loop or channel within which the catheter is held. This addresses the challenge of maneuvering a flexible and slippery catheter within the vagina, providing the operator with control while ensuring tactile guidance. After the external cervical os is identified, an actuation or deployment mechanism with a fail-safe built into the device is activated to assist in catheter insertion, providing controlled deployment to gently advance the catheter into the uterus. This addresses the challenge of generating and directing insertion force toward catheter insertion while limiting uncertainty regarding insertion depth.

[0020] There are multiple embodiments of the present invention, and in one aspect there is provided a device for guiding or assisting the insertion of an elongated medical instrument into an anatomical opening in humans and animals, the device including a manual control body that in use extends along at least a portion of a user's finger, and at least one resistive retaining portion extending from the manual control body, through which the medical instrument is placed and that in use extends along at least a portion of the user's finger to enable the elongated medical instrument to be guided into the anatomical opening.

[0021] The manual control body may be a body that is held by the fingers of a user.

[0022] The manual control body may be a glove.

[0023] The manual control body may be a finger sleeve.

[0024] The manual control body may be a ring.

[0025] The manual control body may include a manual control body worn on one or more fingers.

[0026] The manual control body may have at least one actuation retainer, which may include one or more partially, substantially, or completely annular members through which an elongated medical instrument may be threaded to ensure proper guidance to the anatomical orifice. These actuation retainers may be one or more of a loop, channel, or other tubular structure. In one particular embodiment, the annular member is a resiliently closable C-shaped member.

[0027] The present invention further provides an extension and restraint mechanism that extends the medical device relative to the device interface, thereby allowing deployment to a predetermined projection distance.

[0028] Various mechanisms for advancing or actuating the deployment of the elongate medical device may include one or more of the following: a) Slide mechanism b) Crossbow / Slingshot / Elastic Launch Mechanism c) Syringe drive mechanism d) Spring built-in mechanism e) Winding mechanism f) Pneumatic piston rod drive mechanism g) Hydraulic piston rod drive mechanism h) Electromechanical rod drive mechanism i) Manual or electric rack and pinion mechanism j) pulley mechanism, and k) Bolt action mechanism

[0029] Fail-safe features that may be incorporated into the actuation retainer to prevent excessive insertion depth include (but are not limited to): tactile or audible clicks or bumps, stops (physical or magnetic), visual lines on the device, restraints, notches, grooves, protrusions, tabs, ridges, flanges, flaps, gates, flexible members, elongated guide contours, elongated guide curves, reversible locking mechanisms, etc.

[0030] In one form, the actuation holder may be assembled or disassembled by the user to allow the device to be released from the elongated medical instrument once the elongated medical instrument is in place.

[0031] In another aspect, the actuation retainer may be selectively releasable by a user to allow the manual control body including the actuation retainer to be withdrawn while the elongate medical instrument is held in place. This may be achieved by at least one actuation retainer being selectively releasable by hand or finger manipulative action, such as by spreading the fingers to release a closure elastic or by relative movement of at least a portion of the user's fingers over which the manual control body extends.

[0032] Preferably, at least one resistive retention member is frangible by either cutting, forming a weakened point, breaking at a pre-weakened point, or forcing at least a partial separation from the manual control body. Frangibility may also include releasing a hook-and-loop type connector such as Velcro®.

[0033] Preferably, the device includes a user-controllable fixed retainer at a location away from at least a portion of the user's finger from which the at least one resistive retaining member extends, thereby providing a fixed portion for retracting the at least one resistive retaining member while holding the elongate medical instrument in place. The fixed retainer may be the remainder of the manual control body, the portion of the manual control body that resiliently fits against the user's finger or hand, or an extension strap that extends to be held at a location away from other portions of the actuation retainer.

[0034] It will be appreciated that the present invention can provide for controlled insertion of an elongated medical device, which may include any of the following: ·catheter, Balloons, and Other tubes, Wires, ·rod, Thread, or Other similar structures

[0035] The present invention also provides a method for guiding or assisting the insertion of a catheter, balloon, other tube, wire, rod, thread, or other similar structure into an anatomical orifice in humans and animals in obstetrics and gynecology, comprising the steps of: Mounting the manual control body so that it extends along at least a portion of the user's finger; feeding the elongated medical instrument through one or more at least partially annular members on the manual control body that hold the instrument adjacent to the finger; controlling, manipulating and directing the medical instrument to the targeted anatomical orifice; The annular member can be separated to separate the medical instrument from the manual control body; Removing the user's hand or fingers and manual control body while holding the medical instrument in place.

[0036] It will be appreciated that the present invention provides devices and methods for guiding or assisting the insertion of catheters, balloons, and other tubes, wires, rods, threads, or other similar structures into anatomical openings in humans and animals. This is accomplished by feeding the structure through one or more loops on the device. The loops hold the structure near the fingers of an appropriately trained individual, such as a surgeon, thereby allowing the tubular structure to be controlled and manipulated into the targeted anatomical opening. The loops are then separated, allowing the device to be separated from the tubular structure, thereby permitting the user's hand or fingers to be removed.

[0037] The present invention, in one form, includes a glove that is modified and manufactured to allow for feeding through a loop that assists in guiding the catheter into the cervix, thereby easing the learning curve of the procedure for the operator and increasing insertion rates.

[0038] In its broadest aspects, the present invention may provide a device for guiding or assisting the insertion of catheters, balloons, other tubes, wires, rods, threads, or other similar structures into human and animal anatomical structures, including, but not limited to, the cervix (examples of procedures: cervical ripening by balloon induction of labor, embryo transfer, balloon tamponade, IUPC insertion, etc.) via the female vaginal passage or the urethra (examples of procedures: evacuation of urine from the bladder).

[0039] In one embodiment, the device is worn as a glove that comes in a variety of sizes based on existing or future size standards, or as a finger sleeve sized to fit various sizes of index and / or middle fingers of a glove, or as a non-adjustable one-size-fits-all.

[0040] The device may at least include one or more loops through which a catheter (or other similar device / structure) can be fed to ensure that the device is properly guided into the anatomical opening.

[0041] The loop may be integrally manufactured with the glove or may be partially or completely separable from the glove or sleeve, for example by tearing or cutting the loop. One way to facilitate such separation is to provide an opening (perforation) at the point where the loop is attached to the glove.

[0042] In one embodiment, the loop and glove are made of materials that are safe and biocompatible with the human body and unlikely to cause an immune response (such as an allergic reaction), which may be achieved by using materials currently used in the manufacture of medical gloves (e.g., latex, nitrile, or vinyl), or other suitable materials.

[0043] The materials used may be latex, nitrile, silicone, hydrogel, elastomer, thermoplastic (e.g., PLA, PMMA, ABS, nylon / other polyamides, polyethylene, polypropylene, PPO, PPS, polystyrene, polyetherimide, PEEK, polycarbonate, PVC, polyetherimide, polyethersulfone, cyclic olefin copolymer, PGA, PLGA, polyimide, polyhydroxyalkanoate, polybutylene succinate, PTFE, polyvinylidene fluoride or polyvinylidene difluoride, polydioxanone, polycaprolactone, polyhydroxybutyrate, polyhydroxyalkanoate, PDMS), polymeric materials, plastics, metals, organic materials, synthetic materials, biopolymers, composite materials, and biomimetic materials, or combinations thereof, as needed.

[0044] The device may be provided as is, with an attachable elongate medical device, or may be provided already loaded with said elongate medical device. Other necessary items may also be provided as part of the kit.

[0045] The device may be supplied in a sterile or non-sterile state, and may be supplied pre-lubricated or non-lubricated.

[0046] In one embodiment, the device may include one or more sensors.

[0047] In one embodiment, the device may be attached to other structures or devices that provide access to an anatomical orifice, as required by the application.

[0048] In one form, the present invention provides devices and methods for guiding or assisting the insertion of catheters, balloons, other tubes, wires, rods, threads, or other similar structures into a human anatomical orifice, which may include one or more of the following advantages: i. Improvements in construction and use to minimize stress, discomfort, avoidance, and trauma through efficient and more effectively implemented technology; ii.Improved patient comfort; iii. Improving operator skills in procedures requiring insertion of long medical instruments into anatomical orifices; iv. By improving patient and provider comfort and experience, improved insertion success rates are expected to lead to improved patient outcomes; v. The device reduces medical waste and expenditure on consumables / equipment associated with obstetric applications, particularly IUPC insertion or balloon induction of labor.

[0049] Other aspects of the present invention that will be understood by those skilled in the art from the disclosure herein are also within the scope of the present invention. [Brief explanation of the drawings]

[0050] Notwithstanding any other forms that may fall within the scope of the present invention, preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1] FIG. 1 is a schematic block diagram of the current workflow in obstetric procedures using digital or spreader catheter insertion techniques. [Figure 2] FIG. 2 is a schematic overview of the major elements of a device used to guide or assist the insertion of an elongated medical instrument into an anatomical orifice, in accordance with one aspect of the present invention. [Figure 3] FIG. 3 is a schematic diagram of one embodiment of a device for guiding or assisting the insertion of elongated medical instruments into anatomical orifices in humans and animals in the form of a finger sleeve having a retention member in accordance with the present invention. [Figure 4] FIG. 4 is a detailed schematic diagram of the manual control body of FIG. 3, showing one form of instrument connection having a circular loop. [Figure 5]FIG. 5 is a detailed schematic diagram of the manual control body, such as the finger sleeve, of FIG. 3, showing another embodiment of an instrument interface in the form of a tubular structure for holding an elongated medical instrument. [Figure 6] FIG. 6 is a detailed schematic diagram of the manual control body, such as the finger sleeve, of FIG. 3, showing another embodiment of an instrument interface in the form of a tubular structure for holding an elongated medical instrument. [Figure 7] FIG. 7 is a schematic diagram of a cross-sectional view of a finger of another embodiment of a device for guiding or assisting the insertion of elongated medical instruments into anatomical orifices in humans and animals in accordance with the present invention, having a hand interface in the form of a finger hold device that provides an instrument interface in a clamping configuration. [Figure 8] FIG. 8 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 9A] FIG. 9 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 9B]FIG. 9 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 10A] FIG. 10 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 10B] FIG. 10 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 11] FIG. 11 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 12]FIG. 12 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 13] FIG. 13 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 14] FIG. 14 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 15] FIG. 15 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 16]FIG. 16 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 17] FIG. 17 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 18] FIG. 18 is a schematic illustration of various embodiments of extension and restraint mechanisms for use in devices for guiding or assisting the insertion of elongated medical instruments, including one or more extension mechanisms for controlled extension of the medical instrument to a predetermined distance, including a sliding mechanism, a crossbow / slingshot / elastic firing mechanism, a spring loaded mechanism, a winding mechanism, a pneumatic piston rod drive mechanism, a hydraulic piston rod drive mechanism, a manual rack and pinion mechanism, a pulley mechanism, and a bolt action mechanism. [Figure 19A] FIG. 19 is a diagram of the components and assembly of components in a particularly preferred embodiment of a device for guiding or assisting the insertion of elongated medical instruments using a sliding mechanism as an extension and restraining mechanism. [Figure 19B] FIG. 19 is a diagram of the components and assembly of components in a particularly preferred embodiment of a device for guiding or assisting the insertion of elongated medical instruments using a sliding mechanism as an extension and restraining mechanism. [Figure 20]FIG. 20 is a diagram of the components and assembly of components in a particularly preferred embodiment of a device for guiding or assisting the insertion of elongated medical instruments using a sliding mechanism as the extension and restraining mechanism. [Figure 21] FIG. 21 is a cross-sectional view of a detail of FIG. 20, showing that the instrument interface includes a stop mechanism for engaging the slide mechanism to limit advancement of the medical instrument to a predetermined distance. [Figure 22] FIG. 22 is a schematic diagram of the way the instrument connector is movably engaged with the hand connector, thereby allowing the medical instrument to rotate and / or angulate relative to the operator's guide hand or fingers. [Figure 23] FIG. 23 is a schematic diagram of the way the instrument connector is movably engaged with the hand connector, thereby allowing the medical instrument to rotate and / or change angle relative to the operator's guide hand or fingers. [Figure 24] FIG. 24 is a schematic diagram illustrating steps in an obstetric procedure that may involve one embodiment of a device used to guide or assist the insertion of an elongated medical instrument. [Figure 25] FIG. 25 is a block step diagram of general and more specific methods for guiding or assisting the insertion of catheters, balloons, and other tubes, wires, rods, threads, or other similar structures into anatomical openings in humans and animals for obstetrics and gynecology. [Figure 26] FIG. 26 is a block step diagram of general and more specific methods for guiding or assisting the insertion of catheters, balloons, and other tubes, wires, rods, threads, or other similar structures into anatomical openings in humans and animals for obstetrics and gynecology. DETAILED DESCRIPTION OF THE INVENTION

[0051] It should be noted that in the following description, the same or similar reference numbers refer to the same or similar features in different embodiments.

[0052] Referring to the drawings, there is shown a device used in obstetrics and gynecology to simplify and improve the guidance of the insertion of elongated medical instruments into anatomical orifices in humans and animals.

[0053] In one form, the device is for guiding or assisting the insertion of an elongated medical instrument 18 into an anatomical opening in a person or animal, and includes a manual control body 21 and connectable hand connection portion 22 and instrument connection portion 23. The manual control body 21 is intended to be connected to a hand that is used to guide or assist the insertion of the elongated medical instrument 18 into an anatomical opening in a person or animal.

[0054] The manual control body 21 includes an extension and restraint mechanism 31 that allows the medical instrument 18 to be deployed a predetermined distance by extending it relative to the instrument connector. In this way, the medical instrument can be extended beyond the surgeon's hand and safely extended further into an anatomical orifice of a human or animal patient, or part thereof, when desired.

[0055] The instrument connection portion 23 may further include a release mechanism 41 to allow further advancement of the medical instrument and release of the medical instrument once in place, whereby the medical instrument, during use, extends along at least a portion of the user's finger, allowing manual guidance and further advancement of the elongated medical instrument into the anatomical opening, followed by release and withdrawal of the user's hand.

[0056] The device may include a manual control body 21 that extends over the user's hand 15 and fingers 16 in use. In a first embodiment of the glove, an actuation holder 22 is attached to the user's index finger and is connected to the manual control body 21 to hold a portion of the elongated medical instrument 18 along the hand. Obviously, the actuation holder 22 may be attached to other fingers of the user, with the middle finger being particularly preferred since this is the most prominent, has the most mobility, and can cooperate with the thumb.

[0057] The actuation holder or instrument interface 23 may include multiple components extending from the manual control body 21 and may even partially or completely encircle the user's finger. As shown in Figures 3 and 4, the actuation holder of the instrument interface 23 is comprised of three loops that can hold an elongated medical instrument 18 between the loops and the user's index finger. In this way, during use, the medical instrument 18 extends along the user's index finger, allowing the elongated medical instrument to be manually guided into the anatomical orifice.

[0058] Manual control body 21 may include a fixed retainer 29 to help retain the actuation retainer on at least a portion of a user's hand or finger. If manual control body 21 is a glove, the remaining portion of the glove forms fixed retainer 29 and specifically fits the user's hand to prevent the glove from slipping off when inserting and withdrawing fingers.

[0059] 3 and 4, if the manual control body 22 is a finger sleeve, the fixed retainer extends from the finger sleeve and is held by at least one finger of the user or the remainder of the user's hand. If the fixed retainer 29 is in the form of a strap, it is controllable by the user at a location spaced apart from at least a portion of the user's finger from which the actuation retainer extends, thereby forming a lock to secure retraction of the at least one resistive retaining member while holding the elongate medical instrument in place.

[0060] The manual control body may include a finger ring (not shown), where one or more portions of the at least one retaining member are attachable to encircle a user's finger.

[0061] As shown in FIGS. 5 and 6, a manual control body 21, such as the finger sleeve of FIGS. 3 and 4, may include yet another embodiment of an instrument interface 23 in the form of a tubular structure that holds an elongated medical instrument 18.

[0062] As shown in detail in FIG. 7 , manual control body 21 is a finger hold and may include an actuation retainer of instrument interface portion 23, which takes the form of a finger loop extending outwardly from between two adjacent fingers, the index and middle fingers, to substantially encircle elongated medical instrument 18 therebetween. Locking retainer 29 can be considered a W-shaped finger loop base extending around and around the dorsal surface of the index and middle fingers while retaining elongated medical instrument 18 within the finger loop. Thus, manual control body 21 can be controlled by a user with at least a portion of the user's finger through which the actuation retainer extends, thereby forming a lock to secure retraction of at least one resistive retention member while holding the elongated medical instrument in place.

[0063] The actuation retainers are selectively releasable by a user, thereby allowing the manual control body including the actuation retainers to be withdrawn while the elongate medical instrument is held in place. This may be achieved by at least one actuation retainer being selectively releasable by hand or finger manipulative action, such as by spreading the fingers to release a closure elastic or by relative movement of at least a portion of the user's fingers over which the manual control body extends.

[0064] Preferably, at least one resistive retention member is frangible by either cutting, breaking at a pre-weakened point, or forcing at least a partial separation from the manual control body, which may include releasing a hook-and-loop type connector such as Velcro.

[0065] It is understood that the present invention, in one form, is a medical glove or finger sleeve for guiding, assisting in the control, or manipulating catheters, balloons, other tubes, wires, rods, threads, or other similar structures through anatomical orifices in humans and animals. The glove is intended to be placed on the hand before use, while the finger sleeve (a separate but related device) is intended to be placed on the finger. The device and / or elongated medical implement (hereinafter, for example, referred to as a catheter) is lubricated in the loop portion, which facilitates threading the catheter through the loop and reduces friction caused by the glove material. Because catheters are typically lubricated before insertion into the body, this procedure does not require additional procedures beyond clinical standards. If necessary, a pain reliever such as lidocaine gel or other clinically approved analgesic may be applied. The catheter is then threaded through the loop. [Extension and restraint mechanism (for deployment)]

[0066] 8 to 18, alternative deployment mechanisms for the extension and restraint mechanism 31 are shown, which may be a combination of one or more of the mechanisms described below.

[0067] The following examples illustrate situations in which the catheter carrier (including the catheter) is typically the primary moving part of the device, often moving along a fixed rail and through a fixed finger-sleeve and loop assembly. However, configurations are also envisioned in which the catheter carrier is fixed relative to the finger-sleeve and loop assembly and rail, with the rail being the moving platform for advancing the catheter using the same actuation mechanism principles.

[0068] These example components are identified as follows: a) A: Finger sleeve (hand connection part 22) b) B: Loop / Carrier / Channel (instrument connection part 23) c) C: Catheter (Medical Device 18) d) D: Catheter carrier (extension and restraint mechanism 31) that slides along a rail or loop (B) e) E: The area between the loop (B) and the rail (F) f) F: Rail for slide mechanism or guide operation g) G: A stop mechanism that controls the travel distance and limits the slide mechanism. h) H: A stop similar to G, but serving as a rim for attaching the string (I). i) I: Rubber band or string under tension j) J: Trigger that releases the string and launches the catheter forward. k) K: Spring l) L: Rod that drives the catheter carrier (D) m) M: Chamber 2 (valve not shown) n) N: Bore or piston o) O: Chamber 1 (valve not shown) p) P: A spool that winds a string around the rim (H) and pulls the catheter carrier (D). q) Q: Rack r) R: Pinion with shaft that rotates manually by winding operation s) S: A stop (G) with a hole through which the string (I) passes. t)T: Tab that you pull to start the action u) U: Bolt handle attached to catheter carrier (D) v) V: Slot for guiding the bolt (U) to slide the catheter carrier (D).

[0069] The mechanism in Figures 8 and 9A-9B is a manual sliding mechanism, in which the catheter is loaded into catheter carriers (D) and (B). D then slides forward between points G on rail (F), advancing the catheter into the cervix. The catheter is then inflated, and the entire device slides along the catheter, ready for removal.

[0070] The mechanism of Figures 10A and 10B is similar to the manual slide mechanism of Figure 8, except that the catheter carrier (D) slides along the loop / carrier (B), and D may have a shaft that the operator uses to advance the catheter. A rail (F) may be embedded within (B).

[0071] Figure 11 shows a crossbow / slingshot / elastic launch mechanism in which a catheter is loaded into catheter carriers (D) and (B). D is then pulled back along rail (F) and secured with a latch / trigger (J). Notable components are the string (I) used to launch the catheter by releasing the elastic potential energy via J, and the protrusion (H) that locks the string. After confirming cervical opening, the surgeon can release the trigger to launch the catheter carrier (D), advancing the catheter into the cervix. The catheter is then inflated, and the entire device slides along the catheter, ready for removal.

[0072] Mechanisms not shown include a syringe drive mechanism in which (D) is connected to a screw mechanism in the drive unit that, when actuated, gently advances (D) into the cervix, or (D) may be advanced by movement in conjunction with the drive unit (when using slide mechanism 1).

[0073] Referring to Figure 12, a spring-loaded mechanism is shown, which is similar to the crossbow mechanism and manual slide mechanism 1. Catheters are loaded into catheter carriers (D) and (B). After the cervical opening is confirmed, D is pulled backward along rail (F), compressing spring (K) and storing elastic potential energy. Upon release, this stored energy is converted to kinetic energy, propelling the catheter forward and into the cervix. The catheter is then inflated, and the entire device slides along the catheter, ready for removal.

[0074] Figure 13 shows the spooling mechanism. In this mechanism, a string (I) is connected to a catheter carrier D. A catheter is loaded into catheter carriers (D) and (B). After the opening of the cervix is ​​confirmed, the spool (P) is rotated and the string begins to wrap around the prong (H), which pulls the catheter carrier (D) forward and inserts the catheter into the cervix. The catheter is then inflated and the entire device slides along the catheter and can be removed.

[0075] Referring to Figure 14, a pneumatic piston rod drive mechanism is shown. In this example, a double-acting pneumatic system is used. Valves are not shown. Catheters are loaded into catheter carriers (D) and (B). After confirming cervical opening, the surgeon introduces air or gas (compressed or uncompressed) into chamber 1 (O) and expels air from chamber 2 (M), causing piston (N) to push rod (L) forward. This movement of rod L pushes catheter carrier (D) forward, inserting the catheter into the cervix. The catheter is then inflated, and the entire device slides along the catheter, ready for removal. Note: This mechanism can also function as a hydraulic piston system, where a liquid such as water (instead of gas) is introduced into chamber 1 (O) to advance the piston.

[0076] Figure 15 shows a rack and pinion mechanism. Catheters are loaded into catheter carriers (D) and (B). After the opening of the cervix is ​​confirmed, the surgeon activates the pinion (R) by rotating or winding the mechanism (if equipped with a shaft), which moves the catheter carrier (D) along the rack (Q) until the catheter is inserted into the cervix. The catheter is then inflated, and the entire device slides along the catheter and can be removed. This mechanism can also be electromechanically controlled if the pinion is connected to a DC motor.

[0077] Referring to Figure 16, a pulley mechanism is shown in which a string (I) is connected to a catheter carrier D, extends over a protrusion (H) along the device's undercarriage, passes through a stop (S), and connects to a tab (T). First, a catheter is loaded into catheter carriers (D) and (B). After the cervical opening is confirmed, the surgeon pulls tab (T), advancing D and inserting the catheter into the cervix. The catheter is then inflated, and the entire device slides along the catheter, ready for removal.

[0078] 17 and 18 show a bolt action mechanism, similar to the manual slide mechanism 2, where D enters B and is moved to advance the catheter. In this design, D is connected to a bolt (U) that protrudes from and slides along gap V, allowing the surgeon to deploy the catheter using the bolt action mechanism.

[0079] The lateral (or arc-like) portion of this gap allows D to rotate within B, allowing for control of insertion depth while maintaining the same position in three-dimensional space. This is particularly useful when following a cylindrical coordinate system applied to the shape of B. The catheter is then inflated within the cervix, and the entire device slides along the catheter and can be removed. "Arc" refers to the arc of a circle as applied to the cylindrical loop (B). Designs of the gap (V) similar to a gear shift may also be considered. [Particularly preferred embodiment]

[0080] 19A and 19B, 20 and 21, one embodiment of a device for guiding or assisting the insertion of elongated medical instruments into anatomical orifices in humans and animals is shown. The overall device in this embodiment includes the following components: a) The catheter 18 constitutes a medical device. b) The instrument connection portion 23 forms part of the manual control body 21 and substantially holds the catheter 18 . c) The hand connection part 22 is connected to the instrument connection part 23 and constitutes another part of the manual control body 21. d) The slide 31 constitutes a slide mechanism, that is, an extension and restraint mechanism in this embodiment, and enables deployment of the medical instrument by extending it to a predetermined protruding distance relative to the instrument connecting portion. e) Release mechanism 41 allows the catheter to be released from the instrument connection, allowing the instrument connection and the operator's hands to be removed while the catheter remains in place.

[0081] The components of the manual control body 21 that hold the balloon catheter medical instrument 18 in this procedure are shown in exploded view in FIG. 19A, assembled form in FIG. 19B, in use in FIG. 20, and in cross-sectional detail in FIG. 21.

[0082] These components are comprised of a hand connection part 22 in the form of a finger sleeve that is worn on the operator's finger, and an instrument connection part 23 connected to it. The two are connected via a connecting member 27 that extends from one to the other, forming a movable connection structure that allows the instrument connection part to be controlled by moving the hand connection part with the operator's finger.

[0083] The instrument interface 23 includes an open capture channel guide base 25 and a matching, telescoping guide top cover 26 that clips onto the open capture channel and conceals its internal contours to avoid interference during insertion into the anatomical orifice. It also includes a release mechanism 41 (in this example, tabs that can be squeezed to release the top cover 26; these tabs may also lock the top cover 26 to the base 25).

[0084] The extension and restraint mechanism 31 includes a slide mechanism consisting of an open-channel shaft 32, one end of which is provided with a clip 34 for supporting the medical instrument and sliding it within the instrument connection portion 25, and the other end is provided with a grip 33 that allows the surgeon to initiate the slide and, at a predetermined timing, advance the medical instrument 18 forward so that it protrudes a predetermined distance from the instrument connection portion.

[0085] As shown in detail in Figure 21, the interior of the instrument connection portion 23 includes a protrusion lock 28 at its inner end for defining the starting position of the medical instrument during digital insertion, and a protrusion limit portion 29 at its other inner end that the slide 32 contacts when the surgeon uses grip 33 to advance the slide 32 and attached catheter 18 to a predetermined protrusion distance.

[0086] The hand connector is shaped and sized to be connected to and attached to a hand used to guide or assist in the insertion of an elongated medical instrument, and the instrument connector is shaped and sized to hold a medical instrument and guide or assist in the insertion of the instrument into an anatomical opening in humans and animals, thereby allowing the medical instrument, during use, to extend along at least a portion of the hand connector and one finger of the user, allowing the elongated medical instrument to be manually guided into the anatomical opening.

[0087] The device further includes a release mechanism to allow the medical implement to be released in place, while simultaneously allowing the user's hand and manual control body to be withdrawn while the medical implement remains in place.

[0088] The invention, in one form, can be seen to include three main concepts.

[0089] a) The finger sleeve or hand connection provides the operator with a means of tactile interaction with the cervix, which, through its interface with the instrument connection, allows for precise handling and control of the catheter, thereby ensuring dexterity and maneuverability of the catheter.

[0090] b) The catheter carrier holds the catheter within the actuation retainer or instrument interface and allows for advancement of the catheter through the instrument interface into the cervical canal by sliding the catheter forward with a directional force. This forms part of the extension and restraint mechanism and allows for controlled advancement of the catheter.

[0091] c) The instrument connection provides stability and allows for controlled actuation of the catheter into the cervical canal. In this example, the catheter carrier and catheter are loaded into the open capture channel. A top cover is secured with a clip using a release mechanism to cover the actuation retainer and complete the manual control body. This provides increased control of the catheter and aids in the forward movement of the catheter into the cervix. A fail-safe mechanism is further incorporated into this section 28, 29.

[0092] One step is to advance the catheter further into the target anatomical structure (cervix or uterus). In this important step, the device ensures that the catheter is correctly positioned within the cervical region and is ready for advancement. The device securely holds the catheter and allows the operator to use their other hand to control and advance the catheter. This step highlights the process of "loading the catheter into the manual control body."

[0093] By activating a side button or tab 41 (or other release mechanism) integrated into the open capture channel of the guide portion and top cover of parts 26, 27 of device interface 23, the surgeon can easily remove top cover 26 from the instrument interface, opening access to catheter 18. This mechanism ensures quick and reliable disassembly, an essential feature in enhancing the usability and efficiency of the device.

[0094] 22 and 23, an embodiment of a device is shown in which the hand connection portion covers the tip of at least one of a user's fingers, thereby providing a connection to the hand. The instrument connection portion is movably engaged with a point on the hand connection portion, allowing the instrument connection portion to move relative to the hand connection portion around that point.

[0095] This allows the instrument connector to be either swivel-able or fixed. The unique nature of this articulation allows the surgeon flexibility in its positioning, eliminating the need for excessive adjustments to the finger, hand, or wrist by steering the instrument connector around a single point. This reduces strain and risk of injury for the surgeon, while also reducing patient discomfort and accommodating individual anatomical differences. [How to use]

[0096] Referring to Figure 24, an example of use in an obstetric procedure is shown. In step 1, the balloon of the balloon catheter is placed within the instrument connection portion, and the catheter extends along the surgeon's hand and wrist. At this point, the balloon is not inflated and remains contained within the instrument connection portion. This is because the instrument connection portion is connected to the hand connection portion, which takes the form of a finger sleeve, and is attached to the surgeon's finger, but does not protrude beyond the surgeon's fingertip. Due to the relative connection positions of the instrument connection portion, the hand connection portion is attached to the surgeon, and the instrument does not protrude, allowing the surgeon to safely and controlledly position the medical instrument in a predetermined position. At this stage, in step 2, the surgeon advances the fingertip toward the external cervical os.

[0097] However, in step 3, the surgeon activates the deployment mechanism of the extension and restraint mechanism, causing the balloon catheter to extend forward a predetermined distance from the instrument connection portion.

[0098] In step 4, the balloon is inflated in place, the manual control body is withdrawn along with the catheter out of the vagina, and the release mechanism allows the catheter to be released from the instrument connection portion, allowing the entire manual control body, including the instrument connection portion, hand connection portion, and operator's hand, to be removed while the balloon catheter remains in place in an activated state.

[0099] In use, after the catheter and loop are sufficiently lubricated, a finger is aligned with the anatomical opening (e.g., the cervix to which access is desired via the vagina), and the finger and loop guide the insertion of the catheter into the anatomical opening. Once inserted into the opening, the catheter is deployed and allowed to perform its intended function. For example, in the case of cervical ripening using a balloon catheter, the balloon is inflated to induce labor.

[0100] Upon withdrawal of the user's finger or hand, the loop can be moved distally along the catheter, while holding the catheter in place, to a point where it can be safely cut, torn, disassembled, or otherwise detached, allowing the hand, finger, and device to be removed from the patient's body. In some designs, the loop does not need to be separated, and the device remains connected to the catheter outside the body, or may be removed entirely by sliding it off the catheter (without separating the loop).

[0101] 25, the process in use thus comprises step 101 of placing a manual control body over the user's finger so that the manual control body extends along at least a portion of the user's finger, which may be a glove 11 placed over the hand 20 or a finger sleeve 31 placed over the finger 12.

[0102] In step 102, the elongated medical instrument 18 is inserted through one or more actuation retainers on the manual control body 21, holding the medical instrument 18 adjacent to the finger 16. This allows the user to control, manipulate, and introduce the medical instrument 18 into the targeted anatomical opening in step 103.

[0103] In step 104, the medical device is deployed by actuating the extension and restraint mechanism, which extends the medical device to a predetermined protrusion distance relative to the device interface.

[0104] In step 105, if the medical instrument 18 is to be held in place, the user uses the release mechanism to disengage the medical instrument from the instrument connector of the manual control body, for example, by removing a loop, allowing separation of the medical instrument from the manual control body. This allows the user to remove their hand or finger and the manual control body, while still holding the medical instrument in place, in step 106.

[0105] While the present invention has been described in terms of preferred embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the present invention. This includes, but is not limited to, concepts such as: loops that can be placed in any way around one or more fingers; fingerless gloves or finger rod sleeves; rings; bands; tapes; structures of any length and shape; straps of any kind (including adjustable, detachable, and reattachable); partial loop structures (similar to hooks); and other methods of creating a loop-like interface through which an object can be threaded. It is also recognized that the device may be applicable to other applications beyond obstetrics and gynecology. Finally, it is recognized that other actuation mechanisms may be involved.

[0106] In Figure 26, the operating procedure for performing the obstetric procedure of mechanical induction of labor (Mechanical IOL) of Figure 24 using the device of the present invention includes step 111, in which hand hygiene is performed by aseptic hand washing, followed by step 112, in which the surgeon dons sterile gloves and prepares a sterile environment for the procedure. In step 113, the surgeon opens the packaging that holds the device in a sterile state and places the sterile device in the sterile environment.

[0107] In a subsequent confirmation step 114, the surgeon verifies that the balloon associated with the catheter is inflated and securely attaches the balloon catheter to a device or instrument for guiding or assisting the insertion of elongate medical devices of the present invention into anatomical openings in humans and animals.

[0108] In step 115, the surgeon attaches the hand interface of the device (if it is a fingertip hand interface) to the surgeon's gloved finger, which is a sterile surgical glove.

[0109] In step 116, the surgeon begins digital insertion and identifies the location of the cervix. Then, in step 117, the balloon catheter is advanced to the general location and then extended further to a predetermined distance using the deployment mechanism. Then, in step 118, water is injected into the balloon through the catheter, inflating it at the predetermined location. At this point, the balloon is already free from the extension and restraint mechanisms and is ready to be expanded.

[0110] In step 119, with the inflated balloon held in place, the surgeon withdraws from the vagina and subsequently separates the device from the balloon catheter using the release mechanism, which allows the catheter to be withdrawn through the releasable or open portion of the instrument connection. [interpretation] Embodiment

[0111] The references throughout this specification to "one embodiment" or "an embodiment" mean that the described particular feature, structure, or characteristic is included in at least one embodiment of the present invention. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in multiple places throughout this specification do not necessarily refer to the same embodiment, but may. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, as would be apparent to one of ordinary skill in the art from this disclosure.

[0112] Similarly, in describing exemplary embodiments of the present invention, multiple inventive features may be grouped together in a single embodiment, drawing, or description for the purpose of simplifying the disclosure and making one or more inventive aspects easier to understand. However, this method of disclosure should not be interpreted as indicating an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, aspects of the invention may rely on fewer features than including all features in the foregoing disclosed embodiments. Accordingly, each claim following the detailed description of the preferred embodiment is expressly incorporated into this detailed description, with each claim standing on its own as an independent embodiment of this invention.

[0113] Furthermore, while some embodiments described herein may include only some of the features included in other embodiments, combinations of features from different embodiments are considered to be within the scope of the present invention and may constitute other embodiments, as would be understood by one skilled in the art. For example, in the following claims, any of the claimed embodiments may be used in any combination. [Examples of different object configurations]

[0114] Unless otherwise specified, when ordinal adjectives such as "first," "second," and "third" are used herein to describe a common object, they simply refer to different configurations of the same object and do not imply that the objects must be arranged in any order, whether temporal, spatial, hierarchical, or otherwise. [Specific Details]

[0115] In the description herein, numerous specific details are disclosed. However, it is understood that embodiments of the present invention may be practiced without these specific details. In other instances, well-known methods, structures, and techniques may not be shown in detail so as not to obscure an understanding of the description. [term]

[0116] In describing the preferred embodiment of the present invention illustrated in the drawings, specific terms are used to ensure clarity. However, the present invention is not intended to be limited to such specific terms, and each specific term should be understood to include all technical equivalents that function in a similar manner to achieve the same technical purpose. Terms such as "forward," "rearward," "radial," "circumferential," "upper," and "lower" are used as convenient expressions to indicate reference points and should not be construed as limiting terms. Comprising and Including

[0117] In the following claims and in the above description of the invention, unless the context otherwise requires, either by express language or necessary implication, the word "comprise" or variations thereof such as "comprises" or "comprising" is used in its inclusive sense, i.e. it specifies the presence of stated features and does not exclude that other features may also be present or added.

[0118] As used herein, the words "including," "which includes," "that includes," and the like are all open terms meaning the inclusion of at least the elements or features that follow, but do not exclude others. Thus, including is synonymous with and should be interpreted similarly to comprising. [Scope of the invention]

[0119] Therefore, while what has been described above is considered to be a preferred embodiment of the present invention, those skilled in the art will understand that other changes or further modifications may be made thereto without departing from the spirit of the present invention. It is the intent of this specification to claim all such changes and modifications that fall within the scope of the present invention. For example, any formulas described above are merely representative examples of procedures that may be used. Functions in the functional diagrams may be added or deleted, and operations may be interchanged between functional blocks. Steps may also be added or deleted to the methods described within the scope of the present invention.

[0120] Although the present invention has been described with reference to specific examples, those skilled in the art will appreciate that the present invention may be embodied in many other forms. [Industrial Applicability]

[0121] As will be apparent from the above, the arrangements described herein are particularly applicable to the field of obstetrics and gynecology, but they are also applicable to other medical, veterinary, forensic, scientific and research fields that treat, assist or evaluate humans and animals, or parts thereof, as well as other healthcare industries.

Claims

1. a) a hand connection portion shaped and sized to be connected to and attached to a hand used to guide or assist in the insertion of an elongated medical instrument; b) an instrument connection portion shaped and dimensioned to hold a medical instrument to be guided into an anatomical opening in humans and animals; The medical instrument in use includes a manual control body extending along at least a portion of the hand connection portion and at least one finger of a user, allowing the elongated medical instrument to be manually guided into the anatomical orifice; and c) A device used to guide or assist the insertion of elongated medical instruments into anatomical openings in humans and animals, including an extension and restraint mechanism that allows the medical instrument to be extended relative to the instrument connection portion, thereby enabling it to be deployed to a predetermined distance.

2. d) a release mechanism for allowing the medical implement to be released at a predetermined position, and for allowing the user's hand and manual control body to be withdrawn while the medical implement is held in place.

3. 3. The device of claim 1, wherein the hand connection and the tool connection are integrally connected.

4. 3. The device of claim 1 or 2, wherein the hand connection portion and the tool connection portion are movably connected to allow relative movement between them while remaining connected to each other.

5. 3. The device of claim 1, wherein the hand connection portion and the instrument connection portion are physically separate structures but remain functionally connected, and manual movement of the hand connection portion affects relative movement of the instrument connection portion.

6. 3. The device of claim 1 or 2, wherein the hand interface provides an interface with the hand by covering at least a portion of a user's finger.

7. 3. The device of claim 1 or 2, wherein the hand interface provides an interface with the hand by resiliently engaging between at least a portion of a user's fingers.

8. 3. The device of claim 1 or 2, wherein the hand interface provides an interface with the hand by covering the tip of at least one of the user's fingers.

9. 9. A device according to any one of claims 1 to 8, wherein the instrument connection portion is movably engaged with at least one point on the hand connection portion to allow relative movement of the instrument connection portion about that point.

10. 10. The device of claim 1, wherein the instrument connection portion includes an open capture channel for releasably capturing at least a portion of a medical instrument.

11. The device of claim 10 , wherein the instrument interface includes a clip for releasably capturing at least a portion of the medical instrument.

12. The device of claim 10 , wherein the instrument connection portion includes a sleeve for connection to the medical instrument.

13. The device of claim 10 , wherein the instrument interface includes a resilient clamp for clamping the medical instrument.

14. The device of claim 10 , wherein the instrument connection portion includes a resilient clip for connection to the medical instrument.

15. 11. The device of claim 10, wherein the instrument interface includes a stop mechanism for controlling the extension distance of an extension and restraint mechanism that allows the medical instrument to be deployed by extending it relative to the instrument interface to a predetermined distance.

16. The device of claim 10 , wherein the instrument interface includes a slide mechanism for moving the medical instrument and a stop mechanism for limiting movement of the slide mechanism to a predetermined distance.

17. 17. The device of any one of claims 1 to 16, wherein the open capture channel is blocked by a removable cover, and the release mechanism allows the blocked channel to be removed and the medical device to be removed from the device connection portion, allowing the device connection portion to be removed while the medical device is held in place.

18. 18. The device of claim 17, wherein the removable cover is a frangible cover.

19. 18. The device of claim 17, wherein the removable cover is a sliding cover.

20. 18. The device of claim 17, wherein the removable cover is a tearable strip.

21. 18. The device of claim 17, wherein the removable cover is a releasable cover that is released by operation of one or more releasable tabs.

22. the extension and restraint mechanism: a) Slide mechanism b) Crossbow / Slingshot / Elastic Launch Mechanism c) Syringe drive mechanism d) Spring built-in mechanism e) Winding mechanism f) Pneumatic piston rod drive mechanism g) Hydraulic piston rod drive mechanism h) Electromechanical rod drive mechanism i) Manual or powered rack and pinion mechanism j) a pulley mechanism; and k) Bolt action mechanism 22. The device of claim 1, further comprising one or more of the following features:

23. a manual control body that, in use, extends along at least a portion of a user's hand or finger; an actuation holding portion connected to the manual control body and configured to hold a portion of an elongated medical instrument, the portion of the medical instrument being able to be placed through the actuation holding portion; A device for guiding or assisting the insertion of elongated medical instruments into anatomical openings in humans and animals, wherein the medical instrument in use extends along at least a portion of a user's finger, allowing the elongated medical instrument to be manually guided into the anatomical opening.

24. 24. The device of claim 23, wherein the manual control body includes a hand interface portion having a locking retainer portion that assists in retaining the actuation retainer portion on at least a portion of a user's hand or finger.

25. 25. The device of claim 24, wherein the locking retainer is controllable by a user at a location away from at least a portion of the user's finger from which the actuation retainer extends, thereby ensuring a lock while holding the elongated medical instrument in place when the at least one resistive retention element is withdrawn.

26. 25. The device of claim 23 or 24, wherein the manual control body is a body that is held by one or more of a user's hand and fingers.

27. 24. The device of claim 23, wherein the manual control body is a glove, the actuation retainer being provided on at least one finger of the glove, and the remainder of the glove forming a locking retainer.

28. 24. The device of claim 23, wherein the manual control body is a finger sleeve wearable on at least one finger of a user.

29. 24. The device of claim 23, including a locking retainer extending from the finger-sleeve and adapted to be retained by at least one finger of a user or a remainder of a user's hand.

30. 30. The device of any one of claims 23 to 29, wherein the manual control body includes a finger clip having one or more portions attachable to at least one finger of a user.

31. 30. The device of any one of claims 23 to 29, wherein the manual control body includes a finger hold having one or more portions for being held by a user's fingers.

32. 32. The device of any one of claims 1 to 31, wherein the actuation holder includes at least one annular member through which the elongated medical instrument can be passed, enabling the medical instrument to be properly guided into the anatomical opening.

33. The at least one annular member is a. Loop, b. Channel; c. Other tube structures; d. a resiliently closeable C-shaped member; 33. The device of claim 32, comprising one or more of:

34. 34. The device of any one of claims 23 to 33, including an extension and restraint mechanism that allows the medical device to be extended relative to the device interface and thereby deployed a predetermined distance.

35. 33. The device of claim 32, wherein the extension and restraining mechanism includes a stop mechanism that controls insertion depth.

36. 33. The device of claim 32, wherein the stop mechanism is a locking protrusion or stop provided as part of the instrument interface.

37. 37. The device of any one of claims 1 to 36, wherein the actuation retainer includes at least one resistive retaining element that is selectively releasable by a user to allow the manual control body and the at least one resistive retaining element to be withdrawn while holding an elongated medical instrument in place.

38. The operating holding part is a. Release the elastic closure by spreading your fingers apart; b. moving at least a portion of a user's finger relative to the manual control body extending therefrom; 38. The device of any one of claims 1 to 37, wherein the device is selectively releasable by either

39. 39. The device of any one of claims 1 to 38, wherein the actuation holder has an opening or is partially openable.

40. 40. The device of any one of claims 1 to 39, wherein the actuation retainer is frangible.

41. The operating holding part is a. Breaking due to application of force; b. cutting, c. Creating weakened areas by chemical or thermal treatment; d. Breaking at a pre-weakened location; e. At least a partial forced disconnection from the manual control body; 38. The device of claim 37, wherein the device is frangible by any of the following means:

42. 42. The device of any one of claims 1 to 41, wherein the device is capable of withdrawing an elongated medical device while holding it in place.

43. The medical device comprises: a. a catheter; b. balloon, c. Other tubes, d. wire; e. rod, f. Thread, or g. Other similar structures 43. The apparatus of any one of claims 1 to 42, wherein

44. The prescribed procedure intended for use is Obstetrics, b. Gynecology 44. The device according to any one of claims 1 to 43, which is in the field of

45. The prescribed procedure is a. Through the vagina to the cervix in women i. Mechanical induction of labor (IOL), ii. Fetal scalp electrode (FSE) insertion; iii. Embryo transfer in in vitro fertilization (IVF); iv. PPH (postpartum hemorrhage) management with Bakley balloon / balloon tamponade, v. Hysterocontrast sonography (HyCoSy) or hysterosalpingography (HSG), vi. Insertion of an intrauterine pressure catheter (IUPC); vii. Other transcervical procedures; b. Through the urethra i. Ejection of urine from the bladder; ii. Urethral catheterization 42. The apparatus of claim 41, comprising:

46. The prescribed procedure a. Intrauterine insemination (IUI), b. Cervical cancer screening, and c. Any other procedure that aims to gain access into the uterus via the cervix; 42. The apparatus of claim 41, comprising:

47. a. mounting a manual control body to extend along at least a portion of a user's finger; b. threading the elongated medical instrument through one or more generally circular loops on the manual control body that hold the medical instrument adjacent to the fingers; c. controlling, manipulating and directing the medical instrument to the targeted anatomical orifice; d. Activating an extension and restraint mechanism to deploy the medical device by extending it relative to the device interface to a predetermined projection distance; e. Removable while retaining the medical device in place, allowing the user's hand and the manual control body to be withdrawn; f. Removing the user's hand or finger and manual control body while holding the medical instrument in place; 1. A method for guiding or assisting the insertion of catheters, balloons, and other tubes, wires, rods, threads, or other similar structures into anatomical orifices in humans and animals, the method being adapted for obstetric and gynecological applications, the method comprising the steps of:

48. The medical device a. a catheter; b. a balloon, and c. Other tubes, d. wire; e. rod, f. Thread, or g. Other similar structures 45. The method of claim 44, which may include any of the following:

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