Apparatus and method for insertion and / or pressurization of a balloon catheter for balloon dilation of the eustachian tube and other anatomical passages accessible from the human nostril

Abstract

A method and apparatus for insertion and / or pressurization of a balloon catheter for balloon dilation of anatomical passages in a human head, such as eustachian tubes and paranasal passages. The insertion apparatus comprises a balloon catheter guide tube for receiving and guiding the balloon catheter, and an instrument body fixedly attached to the proximal end of the balloon catheter guide tube. The pressurization apparatus comprises a syringe body having a syringe barrel, a proximal side thruster guide portion, a shape that can be gripped by a hand or finger, a plunger having a distal side plunger head and a plunger rod, and a thruster having a proximal end with a portion that can be gripped by a finger or hand.

Description

[Technical Field]

[0001] The present disclosure (hereinafter referred to as the present disclosure) relates to the field of medical devices. More specifically, the present disclosure relates to methods and devices for inserting and / or pressurizing balloon catheters for balloon dilating anatomical passages in the human head, such as Eustachian tubes and sinus passages.

[0002] Balloon dilation of the Eustachian tube is a treatment for Eustachian tube dysfunction (ETD). This condition is characterized by the inability of the Eustachian tube to ventilate the middle ear. As a result, patients complain of multiple symptoms, including a feeling of ear congestion, a sensation of water filling the ear, tinnitus, muffled or partial hearing loss, clicking or popping sounds, pain or tenderness around the ear, a tickling or tingling sensation, and balance problems. Furthermore, ETD can lead to other serious otitis media. The potential number of patients is enormous, with the prevalence of ETD reported to be as high as 4.6% of the population. Barometric pressure-related problems, such as those during airplane flights and diving, account for up to 10% of cases. The socioeconomic burden of this disease should not be underestimated. ETD-related medical visits are reported to exceed 4 million annually in the United States alone.

[0003] Eustachian tube balloon dilation is a relatively new treatment that is rapidly gaining popularity worldwide for the treatment of Eustachian tube dysfunction (ETD). This procedure has evolved from being limited to adults under general anesthesia to now being performed in standard hospital settings, with clinical trials in children underway. Essentially, the procedure involves inserting a small balloon through the nostril into the Eustachian tube lumen. The balloon is then inflated for several minutes, creating a small scar and ultimately improving the Eustachian tube's opening.

[0004] Several companies offer suitable equipment for this procedure, all of which feature three components: a flexible balloon catheter, an insertion device, and a pressure device. An endoscope (either flexible or rigid) is required for visualization to safely and accurately maneuver and position the device within the nose.

[0005] The flexible balloon catheter is for single use and has a distal inflation balloon portion, an intermediate catheter portion, and a proximal connection portion. The diameter of the distal balloon portion is about 1 mm and, when inflated, expands up to, for example, 5 mm over a length of 20 mm. The proximal connection portion of the flexible balloon catheter is usually provided with a luer lock connection for connection to a separate pressurizing device for inflation. The balloon is inflated using water at 8 - 12 bar. The water flows from the proximal end to the distal end through a flexible intermediate portion having a lumen. The distance from the nostril opening to the eustachian tube opening is on average 90 - 120 mm in adults.

[0006] The balloon insertion device is a hand-held device that includes a rigid, hollow tubular guide tube for inserting a flexible balloon catheter through the nostril into the opening of the eustachian tube or other openings. To accommodate anatomical variations, the guide tube must have an adjustable bend at its distal end. In multi-use devices, there are typically three interchangeable tip angles to choose from. Among single-use devices, there are some that can bend the tip to a desired angle by deforming the tip with a special tool. Since it is normal procedure to adjust the angle at least once to fit the patient's specific anatomical structure, the device may need to be reinserted several times until the correct angle is found. The nasal cavity is narrow horizontally and wide vertically, so when inserting into the narrow nasal cavity, it is normal procedure to direct the bent tip vertically upward or downward until the distal part reaches the required depth. When the tip of the guide tube is inserted to the appropriate depth in the nose, there is a space for checking the position of the eustachian tube opening and the tip can be rotated 45-90 degrees without discomfort. Prior to insertion of the insertion device, the flexible balloon catheter is loaded into the insertion device and the guide tube. At this time, the balloon catheter is made to be slidable within the lumen of the guide tube of the insertion device. Also, the inflatable balloon portion of the balloon catheter is made to protrude from the distal end of the guide tube of the insertion device and advance and extend. Available insertion devices can include a function that facilitates advancing a flexible balloon catheter into the eustachian tube with one hand from the tip of the insertion device. Available insertion devices can further include a function that limits the movement of the balloon so as not to damage the inner ear. When the insertion device is correctly positioned and the distal end of the guide tube is located, for example, at the opening of the eustachian tube, the physician will usually attempt several times to advance the balloon into the eustachian tube, but may not succeed. For the same reason, with the finger hook means of the available insertion device, the physician can insert and remove the balloon catheter from the distal end of the guide tube of the insertion device. Pushing or pulling the insertion device with a finger will cause the part of the device inserted deep into the nose to move unnecessarily, which will cause discomfort to the patient.Among the available insertion instruments, there are some made of stainless steel that can be used multiple times, and there are also single-use only integrated instruments made of plastic, such as Acclarant Aera (trademark), that hold a flexible balloon catheter within the insertion instrument.

[0007] The pressurizing device serves the purpose of inflating the balloon, maintaining a pressure of, for example, 8 - 12 bar for about 2 minutes, and then releasing the pressure to deflate the balloon before extraction. Available pressurizing devices usually comprise a syringe-shaped body with a pressure gauge and a screw-type plunger rod for controlled gear-type pressure actuation. At the tip of the pressurizing device, there is a Luer lock connection that can be airtightly connected directly or via a flexible connection tube to a flexible balloon catheter. These pressurizing devices are always disposable and need to be unpacked, prepared, filled with water, and air purged before connecting to the balloon catheter. Most of the pressurizing devices used for this application are general-purpose devices designed for expanding balloons of various sizes, so the water capacity is as large as 20 ml or more. Also, since the seal cross-sectional area of the plunger is large, a very large plunger operating force is required, thus a screw gear-type operating solution is needed, and generally, very robust and expensive components are required. Due to the screw-type plunger, most commercially available pressurizing devices have to be operated with both hands, so a dedicated clinical engineer is required. In many cases, general-purpose pressurizing devices can have a capacity much larger than that required for eustachian tube balloon dilation. Such pressurizing devices are filled with sterile water from another container such as a plastic bag and hold much more water than the required capacity. The amount of water required for eustachian tube balloon dilation is less than 1 ml, but general-purpose pressurizing devices usually contain 20 ml or more, and the minimum size of the sterile water container found in clinics and private hospitals is usually 100 ml or more. As a result, with each operation, there is unnecessary waste of sterile water, unnecessary waste of the sterile water plastic packaging, and unnecessary waste of the plastic of the large separate pressurizing device. One-handed operable pressurizing devices are also on the market and are described in patent literature, but all require preparation, pre-filling, and air evacuation, and all remain independent devices that can be connected to an individual balloon catheter insertion device. Most pressurizing devices have a pressure gauge and other pressure indicators built-in, and the clinical engineer monitors this pressure gauge during balloon inflation and pressurization to ensure that a constant pressure, for example, 8 - 12 bar, is maintained constant for, for example, 2 minutes.Some pressure devices are equipped with means to limit the pressure so that it does not exceed a predetermined value, for example 10 bar. However, these solutions require constant operation by the operator's hand.

[0008] Endoscopic optical instruments are used to identify the location of anatomical passages such as the eustachian tube and play a role in monitoring the movement and position of the distal end of the insertion instrument that guides the tube throughout the surgery. During the surgery, two instruments are inserted simultaneously through one nostril. They are an insertion instrument that holds a balloon catheter and a visual instrument such as an endoscopic optical instrument for visually and reliably guiding the insertion and inflation of the balloon. Both instruments are cylindrical with a diameter of about 3 - 5 mm. Since the nostrils are very narrow horizontally and wide vertically, the best way is to stack these instruments vertically.

[0009] The endoscopes used include rigid ones with a hard tubular part that enters the nose and flexible ones with a flexible part and a movable tip. Today's endoscopic surgeries are mainly performed using digital endoscopes connected to expensive digital monitors that provide a more convenient view for doctors. Currently, the available devices do not support the use of analog flexible endoscopes with eyepieces, which are most commonly used in small otolaryngology clinics.

[0010] Surgeries using expensive digital rigid endoscopes connected to a monitor require at least two people during the surgery under local needle injection anesthesia or general anesthesia because the patient experiences a great deal of discomfort. The doctor holds the rigid endoscope with one hand while looking at the monitor and handles the insertion instrument with the other hand. To inflate and pressurize the balloon, one or both hands may be used depending on the instrument. Moving two hard instruments in the nose is very uncomfortable for the patient, and in many cases, general anesthesia or local anesthesia by inserting a syringe needle into the tissue in the nose is required so that the patient can tolerate it. Also, anesthesia is required to prevent the patient from suddenly moving at important moments during the surgery. Due to general anesthesia or fear of syringe needles, many candidates may not be able to undergo this surgery.

[0011] For surgeries that use an expensive digital flexible endoscope connected to a monitor, at least two people and usually three are required. The doctor handles the insertion instrument while looking at the monitor. A flexible endoscope is always an instrument that is operated with both hands, requiring a first hand to operate a knob (which is at the proximal end) that controls the distal end that can be bent, and a second hand that supports the distal flexible part of the endoscope outside the patient's nostril. Therefore, one clinical engineer needs to operate the flexible endoscope with both hands, and another clinical engineer needs to operate the pressurizing instrument with both hands. The doctor may also operate the insertion instrument with one hand and the pressurizing instrument that is operated with one hand with the other hand. The flexible endoscope follows along the inside of the anatomical structure and causes less compression on soft tissues, so it is more comfortable for the patient. Skilled surgeons perform flexible endoscope surgeries using only anesthetic gel or spray, but because the instrument moves inside the nose, not everyone can tolerate it.

[0012] Reducing movement and using a flexible endoscope would likely lead to reducing the patient's discomfort and increasing their willingness to undergo surgery.

[0013] An analog flexible endoscope with an eyepiece that does not require an expensive monitor is a major diagnostic tool for otolaryngologists and is available to any private practitioner. However, unfortunately, an analog flexible endoscope cannot be used in combination with a balloon dilation instrument. The reason is that since the operator of an analog flexible endoscope needs to have a visual image, they are forced to place one hand at the proximal end, hold the handle and the eyepiece against the eyeball, and support the flexible part of the endoscope just outside the nostril with the other hand. Therefore, the doctor does not have a free hand to operate the insertion instrument. Since the instrument in the nose cannot be operated haphazardly, it is impossible for a clinical engineer to operate the insertion instrument under the doctor's instructions, and vice versa.

[0014] When the paranasal sinuses are expanded with a balloon, all of the above points are the same. It may be more difficult to identify the location of the opening of the paranasal sinuses, and the paranasal sinus balloon insertion device may include a very thin and flexible guide wire that is inserted into a predetermined paranasal sinus cavity before balloon insertion. The guide wire advancement function may be part of the paranasal sinus balloon insertion device, together with a separate balloon advancement function.

[0015] To greatly improve the usefulness of balloon dilation of the eustachian tube and paranasal sinuses, devices and procedures are needed to support the use of flexible analog endoscopes.

[0016] To further enhance the surgical availability, it would be beneficial to be able to perform the surgery at a lower cost, in a private clinic, without the need for general anesthesia or local anesthesia with a syringe needle, and with reduced patient discomfort.

[0017] US20140074140 discloses several pressurizing devices having several different grip options, several different pressure indicator options, and several different lock mechanism options for locking and releasing the plunger body. All embodiments that enable one-handed pressurization include direct non-gear linear force transmission by hand-pushing, and have a finite number of lockable plunger body positions on a linear path relative to the syringe barrel, as seen in a linear ratchet lock. When a separate pressurizing device is connectable to balloon catheters of various sizes and there is a possibility of adding an unknown number of extension tubes between the pressurizing device and the balloon catheter, the required amount of water pumped from the pressurizing device is unknown, and a pressure monitor and lock positions of multiple plungers will be required.

[0018] US20160106960 discloses several single - hand - operable pressurizing devices equipped with means to prevent the hydraulic pressure from exceeding a certain value. In one embodiment, a conventional pressure relief valve assembly is in fluid communication with the distal end of the syringe assembly via a Y - shaped or T - shaped connection. In other embodiments, different configurations are shown that provide audible and tactile feedback to the operator in different ways when the axial force of the plunger exceeds a certain value. All embodiments require the operator to continuously apply a certain grip force to the plunger during the expansion operation, which can be tiring and may cause hydraulic pressure fluctuations if the operator loosens the grip.

[0019] US9700705 discloses a single - hand - operable pressurizing device equipped with means to prevent the hydraulic pressure from exceeding a certain value by having a valve function that blocks the fluid connection between the syringe barrel and the luer lock outlet when the internal hydraulic pressure exceeds a certain value. The operator needs to apply a certain force to the plunger throughout the surgery, which can be tiring, and the hydraulic pressure may fluctuate if the operator loosens the grip.

[0020] In all embodiments shown in the above - mentioned prior - art patent applications, the pressurizing device is a completely separate device that can be connected to a separate balloon catheter. Therefore, at least one assistant is required. To enable a doctor to perform surgery without an assistant, it would be necessary to integrate the balloon insertion function and the pressurizing function into a single device operable with one hand.

[0021] EP3368139B1 discloses an integrated device including a balloon catheter, an insertion instrument, and a pressurizing unit.

[0022] Here, the pressurizing member is a squeezable bladder (a bag for containing gas or liquid) directly connected to the balloon catheter. In EP3368139B1, it is claimed that with this design, the balloon can be easily advanced with one hand ergonomically and the balloon can be easily expanded with one hand ergonomically. However, although each operation can be performed with one hand, there are two very different hand grip positions for balloon advancement and balloon expansion, and it is not realistically feasible to change the grip position of the insertion instrument with only one hand at this point in the surgery. Once the balloon is inserted into the eustachian tube, the instrument must be held in a very stable state. Therefore, the grip cannot be changed without using both hands. Thus, the other hand does not have the freedom to operate the endoscope, and the procedure cannot be performed without at least one assistant. Furthermore, even if the bladder is compressed by the surgeon's hand, it is not possible to generate a water pressure close to the 8 - 12 bar pressure interval required for balloon dilation of the eustachian tube or paranasal sinuses.

[0023] US20180110407 discloses an instrument configuration in which a balloon catheter insertion instrument includes a fluid delivery mechanism and does not require a separate pressurizing instrument. The fluid delivery mechanism in this configuration consists of a fluid reservoir containing compressed gas, and the fluid reservoir is connected to the balloon catheter proximal filling port via a valve. When this valve is opened, pressurized gas is released from the reservoir, causing the balloon to expand and be pressurized. In this instrument configuration, if the balloon ruptures, a large amount of potential energy accumulated is released inside the inner ear, resulting in a catastrophic outcome. Furthermore, balloon advancement is performed by moving one movable part of the instrument, and opening the valve requires moving another movable part of the instrument. Therefore, it is highly likely that both hands are required to use this instrument. Although it may be possible to operate such an instrument with only one hand, in any case, the operator needs to change the position of part of the hand or part of the finger in order to first operate the movable part (of the instrument) that causes balloon advancement and then operate the movable part (of the instrument) that causes the valve to open. Changing the way of holding the instrument will cause the entire instrument to move slightly, and if the instrument has entered deep into the patient's nasal cavity, the likelihood of increasing the patient's discomfort is very high.

[0024] US20180110407 further discloses another configuration of an instrument in which a balloon catheter is connected to a pressurizing device that can be operated with one hand. In the disclosed configuration, the balloon is expanded by pulling a trigger connected to a plunger that is connected to a fluid reservoir inside the instrument. This configuration has no means for advancing the balloon relative to the instrument body or for extending and advancing the balloon from the tip of a guide tube. The disclosed configuration relies on a separately operated guide tube. This procedure requires one hand to hold the guide tube and the other hand to operate the disclosed instrument configuration consisting of the balloon catheter and the pressurizing device. To advance the balloon, the operator must apply one hand to each instrument and advance the entire assembly relative to the guide tube.

[0025] US20180110407 discloses a plurality of embodiments of an insertion instrument having a function of attaching a distal end of the insertion instrument to a part of a distal end of a rigid endoscope or a flexible endoscope. In these examples, the endoscope and the insertion instrument are bundled at the distal end inside the patient's nose and guided simultaneously. First, the physician inserts the insertion instrument and the rigid endoscope and turns the bent tip of the insertion instrument upward to improve access to the patient and avoid discomfort to the patient. Once positioned, the physician rotates the bundled set of instruments and turns the tip of the insertion instrument sideways with respect to the opening of the eustachian tube or the paranasal sinus. This rotation of the two circular instruments in this rotated configuration widens in the narrow nasal cavity, so this rotation of the bundled instruments causes a high degree of discomfort to the patient. Further, any means for attaching the two instruments, such as an external tube or a clip, will in any case increase the overall cross-sectional area of the inserted instrument and is likely to introduce edges. Further, if the distal ends of the two instruments are fixedly connected so as not to move, compared to two individual instruments that can move independently and find the best painless passage and the best position, it makes it difficult to insert into a narrow and uneven nasal passage without causing pain. In fact, any means for attaching the distal end of the insertion instrument to the distal end of the visualization instrument leads to an increase in the patient's discomfort. Firmly connecting the distal end of the scope to the distal end of the insertion instrument makes it possible to free the hand for a pressure instrument operated with one hand, but the mobility of the endoscope with respect to the insertion instrument is lost or significantly reduced, and the ability to adjust the optimal view is limited because the optimal view is likely to change during the procedure. In a sense, it may be wise to attach the endoscope to the insertion instrument, but it is preferable in many respects that the endoscope is only supported slightly outside the patient's nostril so that the tip of the endoscope can be freely moved and the view can be adjusted throughout the procedure.

[0026] As seen in US20180110407A1, the use of an insertion instrument attachable to the distal end of a flexible endoscope enables procedures using an analog flexible endoscope, but requires two people. In this case, the physician will operate the tip of the flexible endoscope and the insertion instrument with one hand and support the eyepiece at the proximal end of the flexible endoscope with the other hand. The operation of another instrument for advancing and pressurizing the balloon requires a clinical engineer technician.

[0027] In order for balloon dilation to be more accessible to a wider range of people worldwide, it is necessary to use a standard low-cost device such as an analog flexible endoscope so that a physician can perform the procedure alone. By doing so, any private clinic will be able to perform the procedure using an analog endoscope that can be used by a single physician, enabling surgery to be performed at a lower cost and with a higher utilization rate even in rooms with inadequate facilities in a hospital.

[0028] In order to achieve the highest possible utilization rate, it is necessary to reduce the cost of the necessary disposable instruments and the overall cost of the surgery. Currently, the main cost source is indirect costs, which are the costs for operating rooms with advanced equipment in hospitals and advanced clinics with a staff of two to three people. The main cost reduction will be brought about by changing these requirements. Further cost reduction will be brought about by shortening the required procedure time, preparation time, and using inexpensive disposable instruments.

[0029] Also, in the current situation where multiple disposable instruments are combined, a large amount of waste will be generated, which is not environmentally friendly. In order to improve all aspects of this procedure, the environmental footprint must also be considered.

[0030] Finally, it would be a great advantage if the pain and discomfort of the procedure could be reduced so that the procedure can be performed without using general anesthesia or injection needles for local anesthesia. Then, even people with general anesthesia or needle phobia will want to undergo the procedure. Optimally, it is to perform the treatment by reducing the cross-sectional area of the instrument and reducing the movement of the instrument in the nose. Preferably, the endoscope and the insertion instrument are handled with only one hand to reduce the relative movement between the two instruments, and each of the instruments to be inserted is configured to be able to follow the anatomical structure inside the nose so as not to give the patient discomfort as much as possible. It is extremely important that an integrated single-handed operating instrument that controls both the endoscope and the insertion instrument can be operated without changing the hand or finger grip position. By doing so, the movement of the instrument in the patient's nose is reduced and the discomfort is reduced. It is preferable to use a flexible endoscope that bends according to the anatomical structure inside the nose rather than using a hard instrument such as a rigid endoscope. Hard instruments cause greater discomfort to the patient because they force the soft tissue inside the nose to bend.

[0031] US9700705 discloses a system for the insertion and pressurization of a balloon catheter, having a hand-held insertion instrument with a guide tube through which a balloon catheter and a visualization instrument such as an endoscope are independently inserted and guided.

[0032] The pressurization instrument is not attached to the insertion instrument, and there is no guiding means between the pressurization instrument and the insertion instrument. Therefore, in order to move the balloon relative to the insertion instrument and inflate the balloon, one hand must be on the insertion instrument and the other hand must be on the pressurization instrument. A third hand is required to hold the proximal end of the endoscope. Clearly, one doctor and one assistant are required to handle this system. The fact that the endoscope is inside the guide tube may be advantageous when entering from the artificial passage of the canine fossa as shown. However, the outer diameter of the rigid guide tube is quite large to accommodate both the endoscope and the balloon catheter, so it may not be suitable for access through the nostril.

[0033] US10034681B2 discloses a system and method for dilating an eustachian tube, having a guide member with a hollow shaft portion and a handle portion, and an expandable catheter slidable relative to a guide member shaft having an expandable element disposed at a distal end and a drive member disposed at a proximal end. In one embodiment, the drive member has a bladder for inflating a balloon as presented in EP3368139B1. However, it is not feasible to push the bladder by hand to generate the 8 - 12 bar hydraulic pressure required to dilate the eustachian tube or paranasal sinus passage within the balloon. In another embodiment, a button is coupled to a plunger slidably disposed within a fluid reservoir defined within the drive member housing, such that pressing the button causes the plunger to move relative to the fluid reservoir and the balloon to inflate. No guiding means for guiding components of the drive member or syringe assembly relative to the guide member are mentioned, and it is clear that the only interface and guidance between the expandable catheter and the guide member is to coaxially align the expandable catheter shaft with the guide member shaft. It is not obvious how a user can conveniently operate a syringe coupled to or incorporated within the drive member and advance and inflate the balloon catheter with only one hand without changing the grip position of the hand or fingers for the initial advancement and subsequent inflation and operate the guide member.

[0034] In balloon dilation, before advancing a balloon catheter into the dilation passage, it is necessary to place the distal end of the balloon catheter at the correct position in front of the passage to be dilated, and a guide tube or sheath for adjusting to that position is required. For decades, balloon catheters have been used for dilating blood vessels in the human body, and steerable sheaths and guide wires are well-known as accessories used to reach specific passages that cannot be directly accessed with straight or curved guide tubes alone. For dilating passages accessible from the nose, such as the eustachian tube or paranasal passages, it is also advantageous for the distal end of the guide tube to be movable. If the guide tube can be inserted straight from the nostril and bent into a predetermined state inside the nose, the pain during insertion may be reduced. If the distal end of the guide tube can be manipulated, the same guide tube can be used to dilate various passages located at various angles.

[0035] US11020136B2 discloses a steerable guide catheter and method, including a method of using a steerable guide catheter for performing transnasal procedures in the ear, nose, throat, paranasal sinuses or intracranial cavity. Some of the steerable guide catheters of US11020136B2 include a substantially rigid tube, a helical spring attached to and extending from the distal end of the substantially rigid tube, a tubular plastic inner jacket, and an outer plastic jacket substantially covering at least the helical spring member. The spring member is bendable to deform the distal portion of the guide catheter into a curved state. In embodiments for transnasal use, the steerable guide catheter can have a length of less than 25 cm.

[0036] US11376401B2 discloses an apparatus including a body, a drive member assembly, and a guide catheter extending distally from the body. The guide catheter includes an open proximal end, an open distal end, a rigid proximal portion, a bendable distal portion, and a pull wire extending from the bendable distal portion to the rigid proximal portion. The proximal end of the pull wire is coupled to the drive member assembly. The drive member assembly is operable to translate the pull wire relative to the rigid proximal portion, thereby articulating the bendable distal portion.

[0037] All embodiments and descriptions in the introduced prior art show the design of a bendable catheter with a pull wire, where one end of the pull wire is attached to the most distal part of the bendable portion and the other end is attached to a drive member assembly arranged to generate a pulling force on the pull wire. Most of the presented solutions require rotating a knob to generate a pulling force on the pull wire and require both hands. In other drive member assemblies, it is necessary to pull the drive member in the proximal direction. Abstract

[0038] The aim is to increase the availability of procedures mainly including eustachian tube dilation but also including maxillary sinus passage dilation. Currently, only a small fraction of patients who visit an otolaryngology department due to eustachian tube or maxillary sinus passage dysfunction can undergo balloon dilation. This is despite the fact that more patients would benefit from this surgery. The present disclosure greatly changes the requirements of the surgery so that it can be performed in hospitals and advanced clinics with less pain and less anesthesia, more quickly and at a lower cost than conventionally, and can be performed by a single physician in any individual otolaryngology clinic using an available low-cost analog flexible endoscope or rigid endoscope.

[0039] Another aim is to better integrate the balloon catheter, the insertion instrument, the pressurizing instrument, and the endoscope. This can improve the surgery so that it requires fewer personnel and less expensive equipment and reduces the discomfort of the patient.

[0040] As described above, this surgery requires an expandable balloon catheter, an insertion instrument with a hollow guide tube for positioning the balloon adjacent to the opening of the eustachian tube, means for advancing the balloon catheter from the guide tube into the eustachian tube or other passage, a pressurizing instrument for pressurizing the balloon, and an endoscope for visually confirming the correct placement of the balloon. In all available devices and most prior art, at least one assistant is required to assist the physician during the surgery.

[0041] Several aspects and possible implementations aim to improve the surgery in many ways that lead to reducing the patient's discomfort, reducing the number of staff, and reducing the cost of the equipment.

[0042] In the following embodiments and descriptions, a "syringe assembly" includes a syringe barrel having a cylindrical lumen with a fully open proximal end and a distal end having a fluid connection port, a movable seal element that moves linearly along its central axis inside the syringe barrel and is arranged to seal against the cylindrical inner surface, and a plunger rod. The plunger rod is connected to the movable seal element such that the linear movement of the plunger rod relative to the syringe barrel provides an equal linear movement of the movable seal element relative to the syringe barrel.

[0043] According to a first aspect, there is provided a handheld insertion instrument for balloon dilation of the eustachian tube or other anatomical passage of a human. This instrument includes a balloon catheter, a syringe assembly having a plurality of components including a syringe barrel, a seal element, and a plunger rod, a balloon catheter guide tube for receiving and guiding the balloon catheter, an instrument body fixedly attached to the proximal end of the balloon catheter guide tube, and is provided with The balloon catheter has a distally expandable portion that extends from the distal end of the balloon catheter guide tube and advances, and a proximal portion that can be fluidly connected to the syringe assembly for inflation and pressurization of the balloon catheter. The instrument body has guiding means for the movement of one or more parts of the syringe assembly towards the guide tube. The balloon catheter is coupled to one or more parts of the syringe assembly in order to extend and advance the balloon catheter from the distal end of the balloon catheter guide tube by the linear movement of the one or more parts of the syringe assembly.

[0044] By having guiding means for the movement of the syringe assembly towards the guide tube for advancing the balloon catheter, it becomes possible to operate the handheld insertion instrument with one hand without changing the grip position of the hand or fingers. In contrast, prior art instruments require two-handed operation or at least a change in the hand or finger grip position during surgery.

[0045] In an example of an implementation form of the first aspect, the guiding means for the movement of the syringe assembly towards the guide tube is configured to guide the syringe assembly in a straight or slightly curved trajectory towards the guide tube.

[0046] In an example of an implementation form of the first aspect, the guiding means for the movement of the syringe assembly is arranged at the connection between one or more inner surfaces of the opening cavity of the instrument body and one or more outer surfaces or one or more parts of the syringe assembly.

[0047] In an example of an implementation form of the first aspect, the guiding means for the linear movement of the syringe assembly with respect to the guide tube is arranged between the outer surface of the syringe barrel and the inner surface of the instrument body.

[0048] In an example of the implementation form of the first aspect, the guiding means for the linear movement of the syringe assembly relative to the guide tube is disposed between the outer cylindrical surface of the syringe barrel and the inner cylindrical surface of the instrument body.

[0049] In an example of the implementation form of the first aspect, the guiding means for the linear movement of the syringe assembly relative to the guide tube is provided as one or more axial grooves on the outer surface of the syringe barrel and one or more protruding fins on the inner surface of the non-hidden portion of the instrument body.

[0050] In an example of the implementation form of the first aspect, the guiding means for the linear movement of the syringe assembly relative to the guide tube is provided as one or more axial grooves on the inner surface of the non-hidden portion of the instrument body and one or more protruding fins on the outer surface of the syringe barrel.

[0051] In an example of the implementation form of the first aspect, the guiding means for the linear movement of the syringe assembly relative to the instrument body is provided as a rail on the outer surface of the syringe barrel and an opposing rail track on the instrument body so that the syringe assembly can be fully exposed and observed.

[0052] In an example of the implementation form of the first aspect, the insertion instrument is configured to expand a passage accessible from a human nostril, such as an eustachian tube or a nasal sinus passage.

[0053] In an example of the implementation form of the first aspect, the insertion instrument is configured to expand a passage of the urinary system accessible to humans, such as a ureter.

[0054] In an example of the implementation form of the first aspect, the insertion instrument is configured to expand a human blood vessel, such as a coronary artery.

[0055] In an example of the implementation form of the first aspect, the syringe assembly is arranged within the cavity of the instrument body so as to move partially or entirely linearly.

[0056] In an example of the implementation form of the first aspect, the syringe assembly may be arranged such that the distal end of the syringe barrel having the fluid connection port faces the balloon catheter guide tube, and the balloon catheter is in fluid communication with the distal end of the syringe barrel and is attached directly or indirectly to the syringe barrel with respect to the instrument body.

[0057] In an example of the implementation form of the first aspect, the syringe assembly may be arranged in the opposite direction with respect to the instrument body. In that case, the plunger rod is arranged facing the balloon catheter guide tube, the balloon catheter is in fluid communication with the syringe barrel through the lumen of the plunger rod, and the balloon catheter is attached directly or indirectly to the plunger rod.

[0058] In an example of the implementation form of the first aspect, the syringe assembly may be pre-filled with liquid at the manufacturing stage of the insertion instrument. In that case, no pre-operative preparation work is required other than unpacking the insertion instrument. The liquid to be pre-filled may be an exact amount of liquid necessary to fill and pressurize the balloon catheter to an appropriate pressure when the plunger rod and the seal element are arranged at a predefined exact position with respect to the syringe barrel.

[0059] In an example of the implementation form of the first aspect, the instrument body and the guide tube may define a reusable insertion instrument into which a disposable custom single-use syringe assembly and a balloon catheter can be inserted and operated.

[0060] In an example of the implementation form of the first aspect, the insertion instrument including the instrument body, the guide tube, the balloon catheter, and the syringe assembly may be pre-assembled and of a disposable type that can be used only once.

[0061] In an example of the implementation form of the first aspect, the insertion instrument has a first configuration in which the syringe assembly and the balloon catheter are in a first position, the distal portion of the balloon catheter is not inflated, and the plunger rod is retracted with respect to the syringe barrel and is completely housed in the guide tube, and the syringe barrel is preferably filled with water; a second configuration in which the syringe assembly and the balloon catheter are in a second position where the distal portion of the balloon protrudes from the tip of the guide tube and advances; and a second configuration in which the plunger rod is retracted with respect to the syringe barrel; and a third configuration in which the plunger rod is inserted into the syringe barrel, the balloon catheter is in an inflated state, and the syringe assembly and the balloon catheter are in the second position. It has.

[0062] In an example of the implementation form of the first aspect, when the syringe assembly and the balloon catheter are in the second position, it is provided with an end stop that prevents further distal movement of the distal end of the syringe assembly.

[0063] In an example of the implementation form of the first aspect, the distal end of the syringe assembly may be lockable at a number of positions with respect to the instrument body such that the forward distance of the balloon from the distal end of the guide tube is variable and lockable, where the locked position with the balloon fully advanced is understood to be the second position of the syringe assembly and the balloon catheter.

[0064] In an example of an implementation form of the first aspect, the insertion instrument has a first thruster and a second thruster. The first thruster is coupled to the distal portion of the syringe assembly and is configured to move the syringe assembly and the balloon catheter from the first position to the second position. The second thruster is coupled to the proximal portion of the syringe assembly and is configured to move the plunger relative to the syringe barrel for inflation and pressurization of the balloon catheter.

[0065] When the balloon is advanced out of the distal end of the guide tube and inserted into the passage to be expanded, it is very important to stably hold this position of the advanced balloon before and during balloon inflation. This is not difficult when the physician holds the balloon insertion instrument in a stable grip at an appropriate position while the assistant operates a separate pressurizing instrument for balloon inflation. If a pressurizing function is integrated into an insertion instrument that is operated with one hand, it is not desirable to have two different drive members, triggers, or thrusters (pressing tools) that engage. This is because the operator needs to change the hand or finger grip position of the instrument between the advancement and inflation of the balloon catheter, and changing the hand or grip position of an instrument operated with one hand is likely to cause movement of the guide tube and the advanced balloon while it is inserted into the patient's passage. Once the balloon has been properly advanced, the next step, of course, is to immediately inflate the inflatable portion of the balloon catheter. In many respects, it is preferable to move one movable member of the instrument with one finger to advance the balloon and continue the movement of that one finger on that one movable member to inflate the balloon, as this can minimize the movement of the instrument between these treatment steps.

[0066] In an example of an implementation form of the first aspect, the insertion instrument has only one single thruster coupled to the proximal end of the syringe assembly, and the single thruster is configured to first move the syringe assembly and the balloon catheter from the first position to the second position, and then move the plunger relative to the syringe barrel for inflation and pressurization of the balloon catheter.

[0067] If the balloon is accidentally inflated partially or completely while being housed within the guide tube, the balloon catheter may be damaged. Also, if the operator attempts to advance a balloon that has become immobile within the guide tube due to partial inflation, the balloon catheter may be damaged. In a configuration where two different thrusters are used to advance and inflate the balloon respectively, there is a possibility that the wrong thruster will operate first and the balloon will be partially inflated within the guide tube. Using a balloon insertion instrument with only one thruster for advancing and inflating the balloon increases the risk of the balloon inflating within the guide tube. To reduce the risk of damaging an expensive balloon catheter and avoid surgical failure, it would be advantageous to have means to prevent balloon inflation until the balloon has advanced completely.

[0068] In an example of an implementation form of the first aspect, the insertion instrument includes a locking mechanism for preventing movement of the plunger relative to the syringe barrel when the syringe assembly and the balloon catheter are in the first position or between the first position and the second position.

[0069] In an example of an implementation form of the first aspect, the locking mechanism includes one or more resistance elements that create resistance between the plunger and the syringe barrel such that a second force F2 required to move the plunger relative to the syringe barrel is substantially greater than a first force F1 required to move the syringe assembly and the balloon catheter from the first position to the second position.

[0070] In an example of the implementation form of the first aspect, the resistance element is the seal element, the seal element is an element that seals radially with respect to the syringe barrel, and a second frictional force F2 between the seal element and the syringe barrel is significantly greater than a first frictional force F1 between the syringe assembly and the balloon catheter with respect to the instrument body and the guide tube.

[0071] In an example of the implementation form of the first aspect, the resistance element is one or more deformable elements arranged on either the plunger rod or the syringe barrel, and prevents the movement of the plunger rod into the syringe barrel. The second force F2 applied axially to a part of the syringe assembly is necessary to deform the deformable element radially to such an extent that the plunger rod can be inserted into the syringe barrel. In an example of the implementation form of the first aspect, the resistance element is a valve configured to control the passage of liquid between the liquid in the syringe barrel and the balloon catheter lumen. The valve is closed when the hydrostatic pressure of the liquid in the syringe barrel is below the pressure limit and opens when the hydrostatic pressure of the liquid in the syringe barrel exceeds the pressure limit. The second force F2 applied to a part of the syringe assembly is necessary to reach the pressure limit.

[0072] In an example of the implementation form of the first aspect, the resistance element is a flow restriction orifice between the fluid containing space in the syringe barrel and the balloon catheter.

[0073] In an example of the implementation form of the first aspect, the locking mechanism has a first locking mechanism. The first locking mechanism has a movable locking member, the movable locking member preferably has a spherical form, and the movable locking member has a locking position where relative movement between the syringe barrel and the plunger rod is blocked, and an unlocking position where relative movement between the syringe barrel and the plunger rod is possible.

[0074] In an example of the implementation form of the first aspect, in the locking position, the movable locking member is partially received in a recess of the plunger rod and is also partially received in a recess of the syringe barrel. In the unlocking position, the movable locking member is partially received in a recess of the syringe barrel and is also partially received in a recess of the instrument body. The recess of the instrument body is adapted to receive a part of the movable locking member when the syringe assembly and the balloon catheter are in the second position.

[0075] In an example of the implementation form of the first aspect, the means for preventing the balloon from expanding when the balloon is within the guide tube is a hydraulic lock. The hydraulic lock prevents the passage of liquid from the syringe barrel to the fluid connection port of the balloon catheter until the syringe assembly and the balloon catheter are in the second position. Three radial seal rings on the outer surface of the syringe barrel are seals against a cylindrical cavity in the instrument body. A fluid port at the distal end of the syringe barrel penetrates the wall of the syringe barrel radially between the most proximal radial seal ring and the intermediate seal ring. Another fluid port arranged between the intermediate radial seal ring and the most distal radial seal ring is connected to the balloon catheter. One or more grooves on the inner surface of the cylindrical cavity allow fluid to pass from the syringe barrel to the balloon catheter beyond the intermediate radial sealing ring only when the expandable portion of the balloon catheter has advanced completely out of the guide tube and the syringe assembly is in the second position.

[0076] In an example of the implementation of the first aspect, a third force F3 acting directly on a part of the syringe assembly or via a movable member of the insertion instrument is required to pressurize the balloon catheter to a predetermined hydrostatic pressure necessary for successful expansion.

[0077] In an example of the implementation of the first aspect, the first force F1, the second force F2, and the third force F3 are exerted on one end of the syringe - plunger assembly directly or indirectly via other members of the insertion instrument from the same single finger or the same single hand - engagement interface, whereby the operator can advance, inflate, and pressurize the balloon while maintaining the grip of the same hand or finger on the insertion instrument throughout the advancement, inflation, and pressurization of the balloon.

[0078] In an example of the implementation of the first aspect, the first force F1 is from 0 to 5 N, preferably the first force F1 is from 1 to 4 N, and more preferably the first force F1 is from 2 to 3 N.

[0079] In an example of the implementation of the first aspect, the second force F2 is from 2 to 8 N, preferably the second force F2 is from 3 to 7 N, and more preferably the second force F2 is from 4 to 6 N.

[0080] In an example of the implementation of the first aspect, the third force F3 is from 4 to 40 N, preferably the third force F3 is from 7 to 25 N, and more preferably the third force F3 is from 10 to 20 N.

[0081] In general balloon dilation of the eustachian tube or paranasal sinuses, it is necessary to expand the balloon at 8 - 12 bar, for example 10 bar, for several minutes, usually 2 minutes. Applying an external force to the plunger with respect to the syringe barrel and accurately achieving 10 atmospheres over 2 minutes can be physically exhausting and difficult. It is preferable to provide a means for maintaining the pressure during expansion within the insertion instrument without applying an external force.

[0082] In an example of the implementation form of the first aspect, the proximal end of the syringe assembly is lockable at one or more positions directly or through other lockable members of the insertion instrument with respect to the distal end of the syringe assembly.

[0083] In an example of the implementation form of the first aspect, the thruster connected to the proximal end of the syringe assembly is the lockable member that is lockable at one or more positions with respect to the instrument body.

[0084] In an example of the implementation form of the first aspect, an elastic element is disposed between the lockable member of the insertion instrument and the sealing element that seals radially within the syringe barrel, and the elastic element preferably has one or more of a metal spring, a polymer spring, a gas spring, or a spring made of an elastic material.

[0085] In an example of the implementation form of the first aspect, all elastic elements disposed between the movable and lockable member of the insertion instrument and the movable sealing element within the syringe barrel portion of the insertion instrument have a first state and a second compressed state, The third force F3 applied directly or indirectly to a part of the syringe assembly is necessary to compress the elastic element to the second compressed state, and the compressed spring, even when the external force is released, directly or indirectly applies the third force F3 to the movable sealing element within the syringe barrel when the lockable member is locked.

[0086] In an example of the implementation form of the first aspect, here, the lockable member of the insertion instrument is lockable at exactly one predetermined position, This position locks the syringe assembly when the balloon has advanced completely, the balloon has inflated completely, and is completely pressurized to a predetermined hydrostatic pressure. The locking member is locked when the elastic element is in the second compressed state.

[0087] In an example of the implementation form of the first aspect, a pressure relief valve is in fluid communication with the fluid chamber of the syringe barrel, The pressure relief valve is adjusted to open when the hydrostatic pressure exceeds a predetermined hydrostatic pressure required for the expansion procedure.

[0088] In an example of the implementation form of the first aspect, a lumen passing through the plunger rod forms part of the fluid communication between the fluid in the syringe barrel and the pressure gauge.

[0089] In an example of the implementation form of the first aspect, the elastic element is disposed on the liquid side of the movable seal element in the syringe barrel and is connected such that the elastic element is compressed when the plunger rod moves within the syringe barrel

[0090] The elastic element is configured to push back the movable plunger rod when the force applied to the plunger rod is released.

[0091] In an example of the implementation form of the first aspect, an elastic element is connected to the instrument body and the syringe assembly, and when the syringe assembly is moved from the first position to the second position, the elastic element is either compressed or extended, The elastic element biases the syringe assembly to return from the second position to the first position when the applied external force is removed.

[0092] In an example of the implementation form of the first aspect, the cylindrical cavity in the instrument body functions as the syringe barrel of the syringe assembly.

[0093] In an example of the implementation form of the first aspect, the proximal end of the balloon catheter is directly connected to a movable seal element within the syringe barrel.

[0094] In an example of the implementation form of the first aspect, the movable seal element connected to the proximal end of the balloon catheter has a proximal radial seal ring and a distal radial seal ring, a fluid connection port between the two radial seal rings is in fluid communication with the lumen of the balloon catheter, one or more grooves are provided on the inner wall of the syringe barrel, and the grooves form a fluid passage straddling the proximal radial seal ring only when the proximal radial seal ring is axially aligned with the grooves.

[0095] In an example of the implementation form of the first aspect, the instrument body includes an endoscope support structure arranged in conjunction with the hand or finger grip portion of the instrument body to partially support a flexible or rigid endoscope. Only when one or more fingers or a part of the hand of the operator are firmly placed on the grip portion of the instrument body, and thereby a part of the endoscope is pressed against the support structure, the endoscope is fully supported. Such a support structure can be configured as an open groove along at least a part of the outer surface of the instrument body. The open groove is parallel to the balloon catheter guide tube, the depth of the groove is at least 1 mm, the width is at least 2 mm, and the length is at least 10 mm. Preferably, the depth of the groove is 2 mm, the width is 4 mm, and the length is at least 50 mm. Alternatively, the support structure is configured as one or more rows of holes or tubes arranged on the side surface of the instrument body. The holes or tubes preferably have an opening wider than 3 mm and higher than 3 mm. Also, the holes or tubes have a central axis parallel to the guide tube. Alternatively, the support structure is configured as one or more forks arranged in a row on the side surface of the instrument body. The forks preferably have an opening wider than 3 mm and higher than 1 mm. The forks have a central axis parallel to the guide tube.

[0096] In an example of the implementation form of the first aspect, the instrument body includes an endoscope support structure including an elastic band or an elastic clip for fixing a part of the endoscope to the outer surface of the instrument body.

[0097] In an example of the implementation form of the first aspect, the insertion instrument includes a guide wire for confirming correct placement into the anatomical passage before balloon insertion. The guide wire is adapted to move within the lumen of the balloon catheter. Such guide wire components and procedures are well known in combination with balloon catheters and conventional balloon insertion instruments and may be required as part of the first aspect to enable balloon dilation of the paranasal passages.

[0098] In an example of the implementation form of the first aspect, the insertion instrument includes an integrated digital endoscope as part of a disposable complete instrument connectable to an external monitor. The digital endoscope has a camera chip or a lens incorporated at the tip of an optical fiber and / or at a position close to the tip of the guide tube as part of the balloon catheter guide tube. The default field of view of the digital endoscope covers the tip of the guide tube.

[0099] In an example of the implementation form of the first aspect, a single instrument operable with one hand is an integration of an insertion instrument and a pressurizing instrument. A doctor can insert the guide tube into the nostril with one hand without changing the grip of the instrument, push a movable member with one finger to advance the balloon into the eustachian tube or the passage of the paranasal sinus, inflate the balloon, and further push the same movable member forward with the same finger to pressurize the balloon. This integration reduces the number of disposable instruments used in the surgery, which is advantageous both environmentally and cost - effectively. In a certain configuration, this aspect can be used in combination with a digital rigid endoscope operable with one hand, enabling a single doctor to perform the surgery without an assistant. The doctor holds and operates the integrated instrument with one hand and operates the digital rigid endoscope with the other hand while looking at the monitor for navigation.

[0100] In another, more advantageous configuration, the integrated instrument further includes an endoscope support means. In this case, the physician can operate the integrated instrument and use the same hand to support a part of a flexible endoscope or a rigid endoscope. As a result, the other hand of the operator is completely free to support and control the eyepiece part of the analog endoscope or the proximal part of other analog endoscopes or digital endoscopes. By integrating the pressurizing instrument and the insertion instrument into one instrument and providing means for supporting the endoscope on the instrument body, it becomes possible to perform this operation simply and quickly by only one operator without the need for an expensive digital monitoring system, and the pain of the patient is also reduced. Having one small disposable instrument instead of two or three large disposable instruments shortens the preparation time, reduces the cost of the instrument, and is also environmentally friendly.

[0101] According to a second aspect, a method for balloon dilation of an eustachian tube, a nasal sinus passage, or any other anatomical passage accessible from a person's nostril using the insertion instrument according to the first aspect or any possible embodiment thereof is provided. This method comprises a) While gripping the insertion instrument with one hand, inserting the guide tube portion of the insertion instrument into the patient's nostril and into the opening of the anatomical passage to be dilated until it is correctly positioned; b) Extending the distal portion of the balloon catheter out of the distal end of the guide tube and applying a first force F1 in the distal direction to the proximal end of the syringe assembly of the insertion instrument with one finger of the same hand to advance it into the anatomical passage to be dilated; c) Subsequently, applying a second force F2 greater than the first force in the distal direction to the same proximal end of the syringe assembly of the insertion instrument with the same one finger of the same hand to inflate the inflatable portion of the balloon catheter; d) Subsequently, applying a third force F3 greater than the second force in the distal direction to the same proximal end of the syringe assembly of the insertion instrument with the same one finger of the same hand to pressurize the balloon catheter to dilate the anatomical passage; e) In some embodiments, locking the proximal end of the syringe assembly relative to the distal end of the syringe assembly and maintaining the required hydrostatic pressure without applying an external force; f) In some embodiments, unlocking the locked syringe assembly; g) Releasing the force applied to the proximal end of the syringe assembly to release the pressure within the balloon catheter after completion of inflation; h) Retracting the deflated balloon; and including.

[0102] In an example of an implementation of the second aspect, the method includes rotating or bending the distal end of the guide tube to direct the distal end of the guide tube toward the passage to be expanded.

[0103] In an example of an implementation of the second aspect, the method includes advancing a guide wire into the passage to confirm the placement.

[0104] According to a third aspect, there is provided a method of balloon dilating an eustachian tube or any other anatomical passage accessible from a person's nostril using an insertion instrument according to the first aspect or any possible embodiment thereof. The method includes a) Inserting the guide tube portion of the insertion instrument into the nostril and into the opening of the anatomical passage to be expanded while holding the insertion instrument with one hand until it is correctly positioned; b) Rotating or bending the distal end of the guide tube to direct the distal end of the guide tube toward the passage to be expanded; c) Advancing a guide wire into the passage to confirm the placement; d) Using the finger of one hand to push the movable member of the insertion instrument distally from a first position to a second position in order to extend the balloon out of the distal end of the guide tube and advance it into the anatomical passage to be expanded; e) Using the same finger to further push the same movable member forward from the second position to a third position for inflation and pressurization of the balloon catheter; f) In some embodiments, to maintain the required hydrostatic pressure within the balloon catheter without applying an external force, locking the same movable member at a specific position or specific hydrostatic pressure with respect to the instrument body; g) In some embodiments, unlocking the same movable member; h) In some embodiments, pulling the same movable member rearward in the proximal direction from the third position to the second position to contract the balloon; i) In some embodiments, pulling the same movable member rearward in the proximal direction from the second position to the first position to retract the balloon from the passage into the guide tube; j) After successful dilation, pulling out the guide tube and the balloon catheter from the passage and the nostril; including.

[0105] According to a fourth aspect, a handheld insertion instrument for balloon dilation of the eustachian tube or other anatomical passage accessible from a person's nose is provided. The insertion instrument includes a balloon catheter, a balloon catheter guide tube for receiving and guiding the balloon catheter, wherein the balloon catheter has a distal inflatable portion and a proximal portion, the distal inflatable portion is an element that extends out from the distal end of the balloon catheter guide tube, the proximal portion is fluidly connectable to an internal or external inflation / pressurization device for inflation and pressurization of the balloon catheter, and the insertion instrument further includes a drive member coupled to the proximal end of the balloon catheter, an instrument body fixedly connected to the proximal end of the guide tube, and comprising, at least a part of the guide tube extending from the proximal end of the guide tube towards the distal end of the guide tube is linear, the instrument body is in a shape and size that can be held and operated by an operator, The instrument body is provided with a linear track configured to support and guide a part of the cylindrical shaft of a rigid endoscope or a flexible endoscope. The linear track extends parallel to the linear portion of the guide tube.

[0106] In an example of the implementation form of the fourth aspect, the linear track is provided such that the endoscope shaft guided and engaged by the track is disposed in proximity to the guide tube and parallel to the linear portion of the guide tube.

[0107] In an example of the implementation form of the fourth aspect, the linear track consists of a linear groove provided on the outer surface of the instrument body. The groove preferably has a depth of at least 1 mm, a width of 2 mm, and a length of at least 10 mm.

[0108] In an example of the implementation form of the fourth aspect, the linear track has a plurality of U-shaped or C-shaped or V-shaped guide elements arranged to form a linear track for guiding a part of the endoscope shaft.

[0109] In an example of the implementation form of the fourth aspect, the linear track has a plurality of guide plates or walls sandwiching at least a part of the track. The guide plates or walls provide a guide surface facing the track, and the guide surface includes at least one linear element parallel to the linear portion of the guide tube.

[0110] In an example of the implementation form of the fourth aspect, the track is configured to allow longitudinal displacement and rotation of the endoscope shaft with respect to the instrument body, and to restrict lateral movement of the cylindrical object with respect to the instrument body in all directions or in all directions except one direction.

[0111] In an example of the implementation form of the fourth aspect, the instrument body and the track are configured such that a part of the hand of the operator holding the insertion instrument can selectively apply pressure to the endoscope shaft. When pressure is applied, the longitudinal displacement and rotation of the cylindrical object with respect to the instrument body are selectively hindered.

[0112] In an example of the implementation form of the fourth aspect, the linear track is arranged at the distal grip portion of the instrument body. The linear track defines a first central axis parallel to the central axis of the guide tube. The instrument body has a proximal longitudinally elongated portion including a drive member for the forward and backward movement of the balloon catheter. The proximal longitudinally elongated portion of the instrument body has a second central axis.

[0113] In an example of the implementation form of the fourth aspect, an angle is provided between the first central axis defined by the linear track and the second central axis defined by the proximal longitudinally elongated portion of the instrument body. The proximal longitudinally elongated portion of the instrument body is supported by the linear track so as to move away from the central axis of the endoscope shaft in order to obtain more space at the proximal end of the rigid endoscope. The angle is preferably 5 - 90 degrees, more preferably 10 - 60 degrees, and even more preferably 20 - 45 degrees.

[0114] In an example of the implementation form of the fourth aspect, the drive member is engaged with a linear guide track on the downward-facing surface of the proximal longitudinally elongated portion, which faces the position of the endoscope. It is advantageous to arrange any type of drive member on the downward-facing surface of the instrument body because, since the endoscope is arranged on the upper surface, arranging the drive member on the upper surface of the instrument body will collide with the movement of the endoscope and the fingers.

[0115] In an example of the implementation form of the fourth aspect, the insertion instrument includes an inflation / pressurization device for inflating and pressurizing the balloon catheter.

[0116] In an example of the implementation form of the fourth aspect, the pressurizing / dilating device includes a syringe assembly, and the syringe assembly includes a syringe barrel, a plunger rod, and a seal element.

[0117] According to the fourth aspect, an insertion device having an instrument body and a guide tube has support means for supporting an intermediate portion of an endoscope shaft at a hand or finger rest portion of the instrument body, and the intermediate portion is located at a position about 100 mm from the distal end of the entire shaft. The support means is configured to partially support the endoscope, and the endoscope is fully supported only when a doctor firmly holds the hand or finger rest portion of the instrument body, and when the holding is slightly loosened, the position of the endoscope with respect to the guide tube can be adjusted.

[0118] In this aspect, a doctor can operate the insertion device with one hand and support the analog flexible endoscope near the patient's nostril, and operate the proximal end and the eyepiece of the endoscope with the other hand. Meanwhile, an assistant can operate the pressurizing device. Another doctor may choose to use this same aspect in combination with a digital rigid endoscope. Such a doctor can operate the insertion device and the rigid digital endoscope with one hand, operate the pressurizing device operated with the other hand, and perform the treatment alone without an assistant. The advantages of the unique endoscope support function on the instrument body of the insertion device lead to co-guide instruments that free up one hand to reduce staff, make the outer periphery of the instrument inserted into the nostril as small as possible, and reduce the relative movement of the instrument inside the nose, all of which lead to minimizing pain as much as possible.

[0119] According to the fifth aspect, a method for balloon dilating an eustachian tube or any other anatomical passage accessible from a person's nose is provided using the insertion device according to the fourth aspect or any possible interpretation thereof. This method includes a. disposing the endoscope shaft on or within a linear track on the instrument body of the balloon insertion device; b. Grasp the grip portion of the instrument body with a finger or any part of one hand, press a part of the endoscope shaft against the linear track of the instrument body, and fully support at least a part of the endoscope shaft; c. Insert the guide tube of the insertion instrument and the endoscope shaft into a person's nostril simultaneously; d. In some embodiments, adjust the endoscope shaft relative to the guide tube by slightly loosening the grip of the hand portion holding the endoscope shaft relative to the linear track and further rotating the endoscope shaft or translating it inward or outward with the other hand; e. Once the position is confirmed in the visible image of the endoscope, advance the balloon from the tip of the guide tube into the anatomical passage to be expanded; f. Inflate the balloon to expand the anatomical passage; g. Deflate and retract the balloon. including.

[0120] According to a sixth aspect, there is provided an instrument for guiding a balloon catheter through a nostril to an opening of the eustachian tube, paranasal sinus, or other anatomical passage of a person. The instrument includes an instrument body connected to a rigid hollow balloon catheter guide tube and a balloon catheter having an inflatable distal portion and a proximal portion having a fluid connection port. The proximal portion is formed as a cylindrical element configured to move linearly within the cylindrical cavity of the instrument body, one or more radial seal elements on the cylindrical element seal against the inner surface of the cylindrical cavity of the instrument body, the balloon catheter is retracted into the guide tube when the cylindrical element is in a first proximal position, the inflatable portion of the balloon catheter fully advances when the cylindrical element is in a second most distal position relative to the cylindrical cavity of the instrument body.

[0121] In an example of the implementation form of the sixth aspect, a thruster is connected to the cylindrical element in the instrument body, The sealed closed space in the cylindrical cavity of the instrument body adjacent to the cylindrical element defines a gas spring, The gas pressure in the gas spring is 1 atm when the cylindrical element is in the first closest position, When a force is applied in the distal direction to the thruster to move the cylindrical element in the distal direction, a vacuum is formed in the gas spring, and when the force applied to the thruster disappears, the vacuum in the gas spring pulls the cylindrical element, and thus the balloon catheter, back in the proximal direction.

[0122] In an example of the implementation form of the sixth aspect, immediately after successful expansion, a port opens between the gas chamber and the balloon catheter, and a part of the vacuum in the gas chamber is used for the contraction of the balloon, and then the balloon is pulled back into the catheter.

[0123] In an example of the implementation form of the sixth aspect, a fluid connection port penetrating the wall of the instrument body in the radial direction can be connected to an external pressurizing instrument, The cylindrical element disposed in the cylindrical cavity of the instrument body functions as a valve for controlling the passage of fluid flowing from the fluid connection port through the cylindrical element into the balloon catheter, The cylindrical element prevents fluid from passing through the balloon catheter when it is in the first position and any position between the first position and the second position, The cylindrical element allows fluid to pass from the fluid connection port into the balloon catheter only when in the second position. By providing such a valve function, it is possible to prevent the balloon from inflating earlier than intended while the balloon is within the guide tube. Also, with such a valve function, the balloon can be automatically inflated from an external fluid cartridge that is prepared and filled so that the required amount of water can be released at the required hydrostatic pressure.

[0124] In an example of an implementation of the sixth aspect, an elastic element is disposed between the distal end of the cylindrical element and the most distal end of the cylindrical cavity. The elastic element is engaged immediately before the cylindrical element reaches the second position. Before the cylindrical element reaches the second position that allows fluid connection between the fluid connection port and the balloon catheter, the elastic element needs to be compressed. By providing this elastic element, significant tactile feedback is generated for the operator such that the opening of the fluid connection is intentionally performed.

[0125] In an example of an implementation of the sixth aspect, the thruster is connected to the cylindrical element via a rod. This rod is sealed against an internal cylindrical cavity incorporated as part of the instrument body.

[0126] According to a seventh aspect, a system for inflating and pressurizing a balloon catheter is provided. The system includes a balloon catheter, a distal syringe barrel portion having a distal opening for connection to the balloon catheter, a proximal thruster guide portion, and a syringe body having a shape for engagement with an external hand or finger, a distal plunger head having a radial seal element for sealing against the inner surface of the syringe barrel, and a plunger having a plunger rod, a thruster having an engagement portion with a finger or hand at the proximal end. a thruster rod and a spring element, and is provided with the plunger head of the plunger is inserted into the syringe barrel portion of the syringe body, the thruster rod is inserted into the thruster guide portion of the syringe body, the spring element is disposed between the thruster and the plunger such that an axial external force applied to the thruster in the distal direction is transmitted to the plunger via the spring element, the thruster and the syringe body have locking means for locking the thruster to exactly one axial position with respect to the syringe body.

[0127] In an example of an implementation form of the seventh aspect, the locking position of the thruster with respect to the syringe body holds the plunger in a specific position with respect to the syringe barrel when the balloon is fully inflated, and the spring element acts on the plunger head with a specific force to generate a specific hydrostatic pressure required for the inflation procedure inside the syringe barrel and the balloon, so as to hold the spring element at a specific compressed length.

[0128] In the above-described implementation of the seventh aspect, a pressure gauge is not required, nor is an adjustable plunger that an operator operates. In some cases, the operator may misread the dial or numbers on the pressure gauge, or the pressure applied to the balloon may be too high or too low. To reduce the risk of errors, it is desirable for the pressurizing device to have only two modes: a non-inflation mode and an inflation-lock mode in which the correct pressure is applied. Such a system is possible when the wearable balloon is paired with a syringe assembly and the required inflation volume of the balloon is known. However, in the case of such a system, the tolerances of the parts, the spring stiffness, the size of the balloon catheter, and the amount of water filled in the syringe barrel can all affect the tolerance of the internal pressure of the balloon at a specific lock position. It would be advantageous to configure the system such that the amount of water filled injected from the syringe barrel is always higher than the required amount of water in the balloon catheter, and a pressure relief valve in fluid communication with the syringe barrel discharges water when the hydrostatic pressure exceeds a specific pressure required. In this way, with a single lock position, the hydrostatic pressure will not be too low or too high. The closed water volume of the system is calibrated for the specific balloon attached, and subsequent inflation of the balloon is accurately performed at the inflation pressure of one lock position of the thruster.

[0129] In an example of the implementation of the seventh aspect, a pressure relief valve is in hydraulic communication with the water of the syringe assembly, when the hydrostatic pressure in the syringe barrel exceeds a specific pressure required for the expansion procedure, the pressure relief valve opens and discharges water.

[0130] In an example of the implementation of the seventh aspect, the plunger rod has an outer cylindrical diameter that is slightly smaller than the diameter of the inner cylindrical cavity of the thruster rod, the plunger rod is configured to move axially within the thruster rod cavity, a helical spring element is arranged on the plunger rod, The external force applied to the thruster in the distal direction is transmitted from the distal surface of the thruster rod to the plunger head through the helical spring. When an external force is applied to the thruster and the pressure inside the syringe barrel increases, the helical spring is compressed axially.

[0131] In an example of the implementation form of the seventh aspect, two radial seal elements are arranged proximally to the plunger rod and are configured to seal radially against the inner surface of the cylindrical cavity in the thruster rod. A first radial port on the surface of the plunger rod, which is arranged between the two radial seal elements, is in fluid communication with the syringe barrel space through the inner axial lumen of the plunger. A second radial port in the thruster rod connects the inner surface of the cylindrical cavity in the thruster rod to the outer surface of the thruster rod. The second radial port is located at an axial position proximal to the most proximal radial seal element on the plunger rod only when the syringe assembly is in a first stage where the pressure in the syringe barrel is lower than a set value. When the pressure in the syringe barrel becomes higher than the set value, the plunger is further moved proximally relative to the thruster beyond the point where the most proximal radial seal element on the plunger rod passes through the second radial port, thereby forming an open fluid connection from the outer surface of the thruster rod, through the second radial port, through the first radial port, and through the axial lumen of the plunger to the syringe barrel space. In this configuration, the same spring element is used, partly to produce a pressure relief function and partly to apply a force to the plunger head when the thruster is locked.

[0132] In an example of the implementation form of the seventh aspect, the thruster has an axial end stop that is positioned exactly at the lock position or slightly distally of the lock position.

[0133] In an example of the implementation form of the seventh aspect, the locking means has one or more radial structures provided on the outer surface of the thruster rod and one or more opposing structures provided on the inner surface of one or more radially flexible and deformable portions of the thruster guide portion of the syringe body.

[0134] In an example of the implementation form of the seventh aspect, the locking means has one or more internal axial ribs provided on the inner cylindrical surface of the thruster guide portion of the syringe body and a two-part thruster rod having a proximal part and a distal part separate from each other and connected to the thruster engaging portion. The proximal part and the distal part have a cylindrical surface having a diameter slightly smaller than the diameter of the inner cylindrical surface of the thruster guide portion of the syringe body. The proximal part and the distal part have one or more axial grooves aligned with the axial ribs. The proximal thruster rod part has a plurality of angled cam surfaces at its distal end. A plurality of angled cam surfaces that fit exactly to the plurality of angled cam surfaces are provided at the proximal end of the distal thruster part. The angled cam surfaces are configured to convert the axial force from the proximal thruster part into the rotational force of the distal thruster part. The distal thruster part can rotate freely when passing through the end of the internal axial rib at a certain axial position. The cam surfaces of the distal thruster part have one or more axial grooves in the lower cam region every other one, and the cam surfaces of the distal thruster part have a locking surface configured to lock against the distal end of the axial rib in the lower cam region every other one. The axial external force from the gripping portion of the thruster is transmitted from the proximal thruster part to the distal thruster part through the cam surface, and is transmitted from the distal surface of the distal thruster part to the plunger through the spring element. The distal thruster part is toggleable between a state in which it can freely translate along the axial rib and a state in which it is axially locked to the distal end of the axial rib.

[0135] In an example of an implementation form of the seventh aspect, the balloon catheter pressurizing device is pre-assembled and filled with liquid during manufacture.

[0136] In an example of an implementation form of the seventh aspect, the system includes a guide tube for inserting the balloon catheter through a person's nostril in order to expand the eustachian tube or the passage of the paranasal sinus.

[0137] The balloon catheter is configured to move within the guide tube.

[0138] In an example of an implementation form of the seventh aspect, the system includes a guide sheath for inserting the balloon catheter into a person's blood vessel.

[0139] The balloon catheter is configured to move within the guide sheath.

[0140] In an example of an implementation form of the seventh aspect, the system includes a guide sheath for inserting the balloon catheter into the urinary system such as the ureter.

[0141] The balloon catheter is configured to move within the guide sheath.

[0142] In an example of an implementation form of the seventh aspect, the system includes a guide sheath for inserting the balloon catheter into any passage within the human body through a natural or artificial body opening.

[0143] According to an eighth aspect, there is provided a method of inflating and pressurizing a balloon catheter for expanding a passage within a human body using an instrument according to the seventh aspect or any possible interpretation thereof. This method includes a) In some embodiments, while the distal fluid connection port of the syringe body is connected to a liquid source, retract the thruster from the most distal position to the most proximal position to draw the liquid back into the syringe barrel; b) In some embodiments, expel air from the liquid within the syringe barrel; c) In some embodiments, attach the balloon catheter to the catheter connection port of the syringe body; d) Grasp the instrument with only one hand and push the thruster distally into the syringe body until it reaches a firm end stop position where the thruster is automatically locked; e) Lock the thruster in the end stop position relative to the syringe body; f) Release the lock of the thruster; g) Retract the thruster to deflate the balloon; and the like.

[0144] According to a ninth aspect, there is provided a method of inflating and pressurizing a balloon catheter for expanding a passageway within a human body using the instrument according to the seventh aspect or any possible interpretation thereof. This method includes a) In some embodiments, while the distal fluid connection port of the syringe body is connected to a liquid source, retract the thruster from the most distal position to the most proximal position to draw the liquid back into the syringe barrel; b) In some embodiments, expel air from the liquid within the passageway to be expanded; c) In some embodiments, attach the balloon catheter to the catheter connection port of the syringe body; d) Grasp the instrument with only one hand and push the thruster distally into the syringe body until it reaches a firm end stop position where the thruster is automatically locked; e) Push the same thruster distally again to automatically release the lock of the thruster; f) Retract the thruster to deflate the balloon; and the like.

[0145] According to a tenth aspect, there is provided a handheld insertion instrument for expanding an eustachian tube or a paranasal sinus passage accessible from a human nostril. This insertion instrument includes a balloon catheter having a balloon expandable distally and a fluid connection port proximally, a guide tube capable of inserting and guiding the balloon catheter, an instrument body attached to the guide tube, and a drive member, the guide tube has a proximal rigid portion and a distal deformable portion, the guide tube has one lumen for guiding the balloon catheter and one lumen for a pull wire, the pull wire in the pull wire lumen of the guide tube has one end attached to the distal end of the guide tube and the other end fixedly attached to the instrument body for fixing the pull wire, the guide tube can translate linearly relative to the instrument body along its central axis, the drive member is connected to the guide tube, movement of the drive member distally causes the guide tube to move distally relative to the instrument body and the fixed pull wire, thereby bending the deformable portion of the guide tube.

[0146] In an example of an implementation form of the tenth aspect, the deformable portion is biased to be elastically straight.

[0147] In an example of an implementation form of the tenth aspect, the distal deformable portion is deformable only in one plane of deformation.

[0148] In an example of the implementation form of the tenth aspect, the guide tube of the insertion instrument has a deformable tube having the balloon catheter lumen and the pull wire lumen. The proximal end of the deformable tube is connected to the drive member of the insertion instrument, and the distal end thereof is attached to the pull wire. The deformable tube has equal flexibility throughout its entire length. The guide tube further has a rigid straight tube fixedly connected to the instrument body. To prevent the portion of the deformable catheter within the rigid straight tube from bending, and also so that when the drive member, and thus the entire deformable tube, is advanced distally relative to the rigid straight tube and also relative to the pull wire, a part of the deformable tube extending from the distal end of the rigid straight tube can bend, the deformable tube is guided within the rigid straight tube for linear movement.

[0149] In an example of the implementation form of the tenth aspect, the guide tube of the insertion instrument has a deformable tube having the balloon catheter lumen and the pull wire lumen.

[0150] The guide tube of the insertion instrument further includes a rigid straight tube, and the deformable tube is attached and adhered to the rigid straight tube. One distal portion of the deformable tube extends from the distal end of the rigid straight tube, and one proximal portion of the deformable tube is positioned inside the rigid straight tube. One end of the pull wire is attached to the distalmost end of the deformable tube, and the other end is fixedly attached to the instrument body. The rigid straight tube can translate linearly relative to the instrument body. The drive member is attached to the proximal end of the rigid straight tube. The forward distal movement of the drive member, and thus the rigid straight tube, relative to the instrument body and the pull wire causes the deformable portion of the deformable tube to curve.

[0151] In an example of the implementation form of the tenth aspect, a hub is adhered to the proximal end of the deformable tube, an elastic member is disposed between the hub and the instrument body, and when the deformable tube is pushed forward in the distal direction, the elastic member is compressed or stretched.

[0152] In an example of the implementation form of the tenth aspect, any curved state of the distal end portion of the guide tube can be locked by locking the drive member at several positions with respect to the instrument body, the lock preferably includes a releasable one-way lock.

[0153] In an example of the implementation form of the tenth aspect, the one-way lock has a serrated surface along the drive member and a serrated releasable cam of the instrument body facing it, the distal movement of the drive member is enabled by the serrated cam, the proximal movement is not allowed by the cam, and the cam is releasable using a lever.

[0154] In an example of the implementation form of the tenth aspect, in order to rotate the guide tube, a knob attached to the proximal end of the guide tube may be rotated with respect to the instrument body.

[0155] In an example of the implementation form of the tenth aspect, the insertion instrument further includes a second drive member attached to a guide wire disposed within the lumen of the balloon catheter, and the distal movement of the second drive member advances the guide wire from the distal end of the deformable guide tube.

[0156] In an example of the implementation form of the tenth aspect, the insertion instrument further includes a third drive member attached to the balloon catheter, The distal movement of the drive member advances the inflatable portion of the balloon catheter from the distal end of the deformable guide tube.

[0157] In one example of an implementation of the tenth aspect, the insertion instrument further includes a fourth drive member attached to a plunger of a syringe assembly connected to the instrument body, the syringe assembly being in fluid connection with the balloon catheter, and the distal movement of the drive member causing the plunger to move relative to the syringe barrel for inflation of the inflatable portion of the balloon.

[0158] According to these embodiments of the tenth aspect, an insertion instrument that can be conveniently operated with only one hand can be provided. In this insertion instrument, one grip position of the hand does not change during the procedure, and one finger, for example, the thumb, can selectively push the drive member distally to bend the guide tube, advance the guide wire, advance the balloon, and inflate the balloon. The ability to push all drive members distally and have them within reach of one finger, such as the thumb, may be the only possible way to operate all of the functions with one insertion instrument with one hand without changing the grip position.

[0159] According to an eleventh aspect, there is provided a method of inserting and inflating a balloon catheter for expanding an eustachian tube, a nasal sinus passage, or other passage accessible from a person's nostril using the insertion instrument according to the tenth aspect or any possible interpretation thereof. The method includes a) rotating the guide tube of the insertion instrument to a desired angle suitable for reaching the passage to be expanded, depending on the embodiment; b) grasping the insertion instrument with only one hand and inserting the straight guide tube into the person's nostril; c) using the thumb to push the first drive member distally to bend the distal end of the guide tube along the passage to be expanded; d) In some embodiments, using the same thumb of the same hand, pushing a second drive member distally to advance a guide wire within a passageway; e) Using the same thumb of the same hand, pushing a third drive member distally to extend and advance the inflatable portion of the balloon catheter out of the distal end of the guide tube; f) In some embodiments, using the same thumb of the same hand, pushing a fourth drive member distally to inflate the inflatable portion of the balloon catheter; g) After expansion is complete, deflating and retracting the balloon; and including.

[0160] According to a twelfth aspect, there is provided a hand-held insertion instrument for dilating an eustachian tube or paranasal sinus passageway accessible from a person's nostril. The insertion instrument comprises a balloon catheter having an inflatable balloon distally and a fluid connection port proximally, a guide tube for inserting and guiding the balloon catheter, an instrument body attached to the guide tube, a first drive member connected to the proximal end of a mandrel, a second drive member connected to the proximal end of the balloon catheter, and comprising, the first and second drive members being linearly slidable along the instrument body, the guide tube having a proximal rigid portion and a distal deformable portion, the guide tube having one lumen for guiding the balloon catheter and one lumen for guiding the mandrel, the mandrel having a curved and elastically flexible distal end that has a significantly higher rigidity than the distal deformable portion of the guide tube and a significantly lower rigidity than the proximal rigid portion of the guide tube, The movement of the drive member from the first proximal position to the second distal position moves the curved tip of the mandrel from a retracted position inside the rigid portion of the guide tube to a forward position inside a part or all of the distally deformable portion of the guide tube for partial or complete deformation of the distally deformable portion of the guide tube.

[0161] In an example of an implementation of the twelfth aspect, the first drive member may be rotated to rotate the mandrel relative to the guide tube, and while the guide tube is in a patient's nose, the deflection surface and degree of deflection of the guide tube may be manipulated by a single drive member.

[0162] In an example of an implementation of the twelfth aspect, any deflection position and rotational position of the distal end of the guide tube are automatically locked due to the high frictional force between the drive member and the track along which the drive member moves.

[0163] According to a thirteenth aspect, there is provided a hand-held insertion instrument for expanding an eustachian tube or paranasal sinus passage accessible from a person's nostril. The insertion instrument includes a balloon expandable distally, a balloon catheter having a fluid connection port proximally, a guide tube having a curved and flexible distal end for inserting and guiding the balloon catheter, a rigid straight tube surrounding a part of the guide tube, an instrument body for gripping the insertion instrument, a first drive member for moving the guide tube relative to the rigid straight tube, a second drive member connected to the proximal end of the balloon catheter for advancing and retracting the balloon, and the first and second drive members are guided to slide linearly along the instrument body, when the first drive member is in a first position, the curved and flexible distal end of the guide tube is completely retracted into the rigid straight tube, When the drive member is in the second position, the curved and flexible distal end of the guide tube extends completely or partially from the distal end of the rigid straight tube.

[0164] In one example of the implementation of the 13th aspect, the first drive member is connected to the guide tube, and the rigid straight tube is fixedly connected to the instrument body. In the first proximal position of the drive member, the curved and flexible distal end of the guide tube is completely retracted into the rigid straight tube. In the second distal position of the drive member, the curved and flexible distal end of the guide tube extends completely or partially from the distal end of the rigid straight tube.

[0165] In one example of the implementation of the 13th aspect, the first drive member is connected to the rigid straight tube, and the guide tube is fixedly connected to the instrument body. In the first distal position of the drive member, the curved and flexible distal end of the guide tube is completely retracted into the rigid straight tube. In the second proximal position of the drive member, the curved and flexible distal end of the guide tube extends completely or partially from the distal end of the rigid straight tube.

[0166] In one example of the implementation of the 13th aspect, a knob for rotating the guide tube is connected to the proximal end of the guide tube.

[0167] In one example of the implementation of the 13th aspect, a single drive member may rotate and translate the guide tube relative to the rigid tube, and during the guide tube is in the patient's nose, the single drive member may operate the deflection surface and the degree of deflection of the guide tube.

[0168] In one example of the implementation of the 13th aspect, due to the high frictional force between the drive member and the track along which the drive member moves, any deflection position and rotational position of the distal end portion of the guide tube are automatically locked.

[0169] Balloon insertion devices often have a drive member that can be pushed distally with a finger to advance a guide wire distally, and a drive member that can be pushed distally with a finger to advance a balloon catheter distally. When an operator operates such an insertion device with only one hand without changing the grip position, it would be advantageous to have a drive member that can be pushed distally with a finger to bend the distal end of the guide tube while the guide tube is being inserted into the patient's nose.

[0170] According to a fourteenth aspect, a hand-held insertion device for balloon dilating an eustachian tube or other anatomical passage in a human head is provided. The insertion device a pressurizing device connected to a movable member configured to be moved by a finger of an operator's hand holding the insertion device, a balloon catheter, a guide tube for receiving and guiding the balloon catheter, and wherein the balloon catheter has a distally expandable portion that will project distally from the distal end of the balloon catheter guide tube, and a proximal portion fluidly connected to the pressurizing device for inflation and pressurization of the balloon catheter, the insertion device further comprising a drive member coupled to the balloon catheter and configured to project and advance the distally expandable portion distally from the distal end of the guide tube, the drive member also being coupled to the movable member, the movable member being configured to move substantially distally from a most proximal position to an intermediate position and from the intermediate position to a most distal position, the drive member being configured to project and advance the distally expandable portion distally from the distal end of the balloon catheter guide tube when the movable member is moved from the most proximal position to the intermediate position, the pressurizing device being configured to inflate and pressurize the balloon catheter when the movable member is moved from the intermediate position to the most distal position.

[0171] These aspects and other aspects will become further apparent from the examples and embodiments described below.

Brief Description of the Drawings

[0172] Hereinafter, various concepts, embodiments, and implementation examples will be described in detail with reference to the exemplary embodiments shown in the drawings.

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[0173] FIG. 1 is a side view of the head 1 of a human patient, showing a prior art instrument for eustachian tube dilation inserted into the nose. A typical insertion instrument 2 includes a balloon catheter guide tube 3 that holds a balloon catheter therein. The proximal portion of the balloon catheter extends out of the proximal portion of the insertion instrument 2 and can be connected to a pressurizing instrument 4 via a flexible tube. A flexible endoscope 5 having a flexible distal portion 6 inserted into the same nostril is also depicted. Using the depicted instruments requires three people to perform the surgery. The physician (operator) operates the insertion instrument 2 and advances the balloon into the eustachian tube using the slider of the insertion instrument. The first clinical engineer (operator) holds and operates the pressurizing instrument 4 with both hands. The second clinical engineer (operator) holds and operates the flexible endoscope 5. One hand holds the proximal portion of the endoscope and operates the movable distal tip of the scope, and the other hand supports the flexible intermediate portion 6 of the endoscope near the patient's nostril.

[0174] FIG. 2 is a partial vertical cross-sectional view through the nasal cavity 8 on the right side of the human head 1, showing a typical prior art instrument. From this cross-sectional view, it can be seen that in order to reach the opening of the eustachian tube 7, the guide tube 3 of the insertion instrument 2 must be placed deep within the nasal cavity 8. A flexible endoscope 6 is depicted, but it is clear that the tip of any endoscope must be adjacent to the tip of the guide tube 3 in order to visually confirm the position of the tip of the guide tube in front of the opening of the eustachian tube 7 before inserting the balloon.

[0175] FIG. 3 shows a procedure being performed on a fully sedated patient 12 using a rigid (hard) digital endoscope 13 connected to a digital monitor 7 to easily visualize the interior of the nose. A trained physician 10 can operate the rigid endoscope 13 with one hand and a typical prior art insertion instrument 2 with the other hand. A clinical engineer (operator) 11 operates the typical prior art pressurizing instrument 4 with both hands. Although it may be possible for a trained physician 10 to operate both the insertion instrument 2 and the rigid endoscope 13, it is highly uncomfortable for the patient and requires either a general anesthesia or a local needle injection anesthesia.

[0176] Figure 4 shows a procedure performed by only one doctor (operator) 10 using the handheld insertion instrument 16 according to the embodiment on a fully awake patient 14 with the analog flexible endoscope 15. The doctor 10 grips the insertion instrument 16 with the first hand, and also supports the flexible part of the analog endoscope 15 with the same first hand. The doctor 10 holds the proximal part of the analog flexible endoscope 15 with the second hand. The doctor 10 can hold the insertion instrument 16 at the same finger grip position (i.e., without changing the finger grip position) during the insertion into the nose, during the advancement of the balloon, during the inflation, pressurization, and contraction of the balloon, during the final withdrawal from the nose, and throughout the entire procedure in this way. By controlling the tip of the guide tube of the insertion instrument 16 and the tip of the analog flexible endoscope 15 with the same hand without changing the finger grip position, the instrument can be moved hardly at all inside the nose, and it is almost impossible to give discomfort to the patient 14, increasing the possibility that the patient can tolerate the procedure using only a cotton pledget soaked with a local anesthetic and a decongestant.

[0177] Figures 5a and 5b show an example of a balloon catheter 20 having a proximal fluid connection port 21 for connection to an inflation device, an inner catheter shaft, and a distal inflatable balloon. Figure 5a shows a state where the balloon is not inflated. Figure 5b shows a state where the balloon is inflated. The catheter shaft is a tubular element having a lumen communicating with the inside of the inflatable part. The proximal connection part is configured to be connected to an inflation / pressurization device. The inflatable part is configured to inflate into a substantially cylindrical balloon having a predetermined diameter in the inflated state.

[0178] When expanding the eustachian tube or the paranasal sinus passage with a balloon, the size of the inflated balloon can be about 3 - 7 mm in diameter and about 15 - 30 mm in length. The balloon catheter 20 may have a lumen for a guide wire. Any of the balloon catheters 20 in the following embodiments may be configured to include a lumen for a guide wire, a guide wire port, and a guide wire. One kind of available balloon catheter 20 with and without a guide wire is well known to anyone in this field.

[0179] Figures 5c, 6A-C, 7A-B and 8A-B show a first embodiment of the handheld insertion instrument 17 with an integrated pressurizing device. The insertion instrument 17 enables a single physician to perform a surgery in combination with a digital rigid endoscope. The physician (operator) holds the digital rigid endoscope in one hand and the insertion instrument 17 in the other hand. After preparation of the insertion instrument, the physician can hold the insertion instrument 17 with one hand, at one finger grip position, throughout the insertion of the instrument, advancement of the balloon, inflation of the balloon and pressurization.

[0180] The insertion instrument 17 has an instrument body 18 firmly attached to the balloon catheter guiding tube 19. This assembly can be of single-use or reusable type and is autoclave sterilizable. In the initial state, the balloon catheter 20 is pre-loaded in the insertion instrument 17. The balloon catheter 20 is provided with guiding means for guiding the balloon catheter 20 linearly with respect to the instrument body 18. It also has a proximal connection part 21 with a connection interface for preventing fluid leakage (i.e., for sealing) in the fluid connection with the syringe barrel 22. A manometer gauge 23 is attached to the connection part 21. The connection part 21 smoothes the fluid connection among the balloon catheter 20, the syringe barrel 22, and the manometer gauge 23. The insertion instrument including an improved syringe barrel 22 having an improved plunger rod 24 has guiding means 25 that enable insertion into the instrument body 18 and linear guiding with respect to the instrument body 18 respectively. In this embodiment, the guiding means 25 has lateral fins extending from the syringe body, and the tips of the fins are received in axially extending grooves on the opposing inner surfaces of the instrument body 18. Alternatively, the guiding means 25 may comprise laterally extending fins guided by the inner surface of the instrument body (not shown). The guiding means 25 can also be formed by axially extending guiding rails inside the instrument body that engage with grooves on the outer surface of the syringe barrel or grooves on the protruding part from the syringe barrel. Such a protruding part of the syringe barrel may be provided with an eyelet (small hole) for the guiding rail to extend (not shown). The instrument body 18 has an interface operated by the thumb or other finger formed by a recess or hole 26 on one side. Through this interface, the operator can monitor the positions of the plunger rod and the syringe barrel, and through this interface, the operator's thumb can access the finger interface 26 of the plunger rod 24. The plunger rod 24 has one or more valves (returns) configured to interlock with the linear ratchet corresponding part 27 of the instrument body 18.

[0181] Figures 6A, 6B, and 6C respectively show three different stages of preparation before inserting a syringe assembly with a syringe barrel 22 and a plunger rod 24 into the instrument body 18. Figure 6A shows the first stage.

[0182] At this time, the plunger rod 24 is at the back (fully inserted position) of the syringe barrel 22. Figure 6B shows the state after the operator fully withdraws the plunger rod 24, thereby filling the syringe barrel 22 with a fluid such as water from another container. The plunger rod 24 is at the uppermost position (fully withdrawn position). Figure 6C shows the final position after discharging air from the syringe barrel 22. This final position of the plunger rod 24 relative to the syringe barrel 22 is felt by the operator as a tactile feedback given by a sudden increase in resistance when pushing the plunger rod 24. One or more bumps (protrusions) 28 are provided on the plunger rod 24 at a predetermined position, protruding beyond the inner diameter of the syringe barrel 22. To deform the plunger rod 24 and further push the plunger rod 24 into the syringe barrel 22, it is necessary to increase the force applied to the plunger rod 24. These bumps 28 partially serve to inform the operator that the air discharge is completed and the position of the plunger rod is correct during preparation, and also secondarily serve as a preventive measure to ensure that the balloon advances prior to liquid injection and balloon inflation when a force is applied to the plunger rod 24. This is because the force required to advance the balloon is much smaller than the force required to further move the plunger rod 24 into the syringe barrel 22.

[0183] Figure 7A is a perspective view of the insertion instrument 17. A slot 30 is provided in the instrument body 18 on one side of the insertion instrument 17 where a prepared syringe assembly 29 is ready to be loaded into the instrument body 18. The slot 30 enables the manometer 23 to advance and further enables the operator to monitor the movement of the syringe assembly 29.

[0184] Figure 7B is also a perspective view of the insertion instrument 17 according to the same embodiment. In the state of Figure 7B, the syringe assembly 29 is fully inserted into the instrument body 18 and is connected to the balloon catheter proximal connection portion 21. The thumb / finger interface 26 on the plunger rod 24 can be pushed and pulled using the thumb so that the balloon can be inflated and deflated when attempting to enter the eustachian tube or other passage to be dilated.

[0185] Figure 8A is a cross-sectional view of the insertion instrument 17 of this embodiment, in the first position where the insertion instrument 17 is loaded and ready. The syringe barrel 22 with the plunger rod 24 is fully inserted into the instrument body 18 and is connected to the connection portion 21 of the balloon catheter 20. The connection portion 21 can be provided with a protruding bump 31 that engages with the hole of the instrument body 18, functions as a tactile feedback indicating the correct starting position of the assembly, and also introduces a first force that needs to be overcome to start the advancement of the balloon catheter 20. The force required to advance the balloon is significantly smaller than the force required to move the plunger rod 24 and thus the movable seal element 202 relative to the syringe barrel 22 in order to inject the fluid 32 from within the syringe barrel 22 into the balloon catheter 20. Thereby, the advancement of the balloon catheter 20 is ensured prior to the inflation of the balloon.

[0186] Figure 8B is a cross-sectional view of the insertion instrument 17 of this embodiment in the second position.

[0187] At this time, the balloon catheter 20, the connection part 21, the syringe barrel 22, and the plunger rod 24 have all advanced to a second position relative to the instrument body 18 in order to completely advance the inflatable distal part of the balloon catheter 20 from the guide tube 19. The protruding bump 31 of the connection part 21 is deformed so as to allow relative movement with respect to the instrument body 18. However, since the bump 28 of the plunger rod 24 has not yet been deformed, it can be seen that the plunger rod 24 and the movable seal element 202 are kept such that their relative positions with respect to the syringe barrel 22 do not change. The balloon catheter 20 and the syringe assembly may be able to move back and forth between a fully retracted position and a fully advanced position without relative movement between the plunger rod 24 and the syringe barrel 22 and without the plunger rod 24 interlocking with the ratchet lock function of the instrument body 18. In this way, the operator can push and pull the finger interface 26 of the plunger rod with the thumb to extend and retract the balloon catheter 20 from the tip of the guide tube 19, and attempt to insert the balloon catheter 20 into the eustachian tube or other passage to be dilated.

[0188] Figure 9A is another vertical cross-sectional view of the insertion instrument 17 in the third configuration of this embodiment.

[0189] As the balloon catheter 20 advances and the plunger rod 24 moves relative to the syringe barrel 22 (entering the syringe barrel 22), fluid 32 is injected from the syringe barrel 22 into the balloon catheter 20 for balloon inflation. In this cross-sectional view, the fluid connection between the syringe barrel 22, the balloon catheter 20, and the manometer 23 can be seen. In this cross-sectional view, the state in which the plunger rod 24 and the instrument body 18 are engaged with each other at the ratchet interface 27 to prevent the reverse movement of the plunger rod 24 with respect to the instrument body 18 is shown.

[0190] FIG. 9B is a cross-sectional detail view of a linear ratchet lock 27 between the plunger rod 24 and the instrument body 24. To release the ratchet lock 27, the operator applies force to the release lever 34 with the thumb 33 and pulls the proximal end of the plunger rod 24 slightly outward to release the ratchet lock 27, thereby releasing the pressure within the balloon catheter 20.

[0191] FIG. 10 is a graph showing the relationship between the force F and the distance S when the operator pushes the insertion instrument 17 to advance, expand, and pressurize the balloon. This graph shows the force-distance relationship for the first and second embodiments of the insertion instrument 17. The operator needs to overcome the force f1 to start the advancement of the balloon catheter 20. There are bumps that need to be deformed or friction between parts in the insertion instrument 17. Once the force f1 is overcome, the operator can move the finger interface 26 from s0 to s1, thereby fully advancing the balloon. When the balloon catheter 20 is fully advanced, the operator feels a large resistance. Unless f2 is exceeded during advancement, the operator may repeat retracting and advancing the balloon catheter 20 again. When the operator fully advances the balloon catheter 20 and further applies a force of f2 or more to the finger interface 26, the plunger rod 24 moves relative to the syringe barrel 22, and as a result, the liquid for balloon inflation is injected from the syringe barrel 22 into the balloon. The force f2 may be due to deformation of parts or friction between the plunger rod 24 or the movable seal element and the syringe barrel 22. The force f2 may be large at first and may slightly decrease during the movement of the plunger relative to the syringe. The difference between the forces f1 and f2 is important because it functions as a preventive measure to prevent the balloon from being inflated accidentally while it is still inside the guide tube 19. The distance s2 of the finger interface 26 is reached when the balloon is fully inflated. Considerable force f3 needs to be applied to reach the rated balloon pressure for the expansion stage. The system is very "hydraulically" "stiff". However, only a very small movement from s2 to s3 is required to reach the required force f3. Because the system is very "stiff", the possible ratchet positions (which prevent reverse rotation of the plunger rod 24) have a large impact on the resulting pressure. Furthermore, small deformations of the instrument parts or tissue can cause a rapid pressure loss and may require readjustment.

[0192] Figures 11 to 18 show a second embodiment 35 of a handheld insertion instrument. Also in the case of the handheld insertion instrument 35 according to this embodiment, in combination with a digital rigid endoscope, a treatment can be performed by only one doctor (operator). The doctor operates the insertion instrument with one hand while looking at the digital monitor of the rigid endoscope for navigation, and operates the rigid endoscope with the other hand.

[0193] Figure 11 is a perspective view of this second embodiment 35 of the handheld insertion instrument. In this embodiment, the handheld insertion instrument 35 includes an instrument body 36 firmly coupled to a balloon catheter guide tube 37, an inverted syringe barrel 42 partially and loosely inserted into the instrument body 36 and preferably having linear guiding means (e.g., radial fins as shown, or other protrusions from the instrument body 36), and a plug 40 capable of sealing a syringe barrel filling port 39. The syringe barrel 42 is in fluid communication with a manometer gauge 38. The syringe barrel 42 further has a filling port 39.

[0194] Figure 12 is a cross-sectional view of the handheld insertion instrument 35 at a first preparation stage. A water-filled syringe 41 (which may be an existing technology syringe) is connected vertically upward to the filling port 39 of the syringe barrel 42 of the insertion instrument 35. A plunger rod 43 having a seal element 44 and a resistance element 45 has an internal fluid connection lumen 46 and is directly connected to a balloon catheter 47. The plunger 43 is locked to the instrument body 36 by a locking portion 48 and does not move relative to the instrument body 36 at any preparation stage. In the initial starting position, the plunger 43 is located at the back of the syringe barrel 42 of the insertion instrument 35.

[0195] Figure 13 shows the second preparation stage of the handheld insertion instrument 35 according to this second embodiment. By pulling out the syringe barrel 42 of the instrument with respect to the plunger rod 43, a part of water or any liquid 49 is transferred from the ordinary syringe 41 to the syringe barrel 42 of the insertion instrument 35. At this time, the position of the plunger rod 43 with respect to the instrument body 36 does not change due to the lock portion 48. The movement of the syringe barrel 42 is restricted by the one-way lock portion 52.

[0196] Figure 14 shows the handheld insertion instrument 35 in the third preparation stage. At this stage, when the syringe barrel 42 is pushed back into the instrument body 36 to a certain position, air is discharged from the syringe barrel 42 of the insertion instrument 35. When the syringe barrel 42 of the insertion instrument 35 is sufficiently pushed back to a predetermined position, visual and tactile feedback is provided to notify the operator. For this purpose, a resistance element 45 such as an O-ring or a protrusion on the plunger rod 43 is provided. The resistance element 45 is arranged at a position such that the insertion of the resistance element 45 into the syringe barrel 42 of the insertion instrument 35 causes a sharp increase in resistance when the plunger 43 is accurately positioned with respect to the syringe barrel 42 of the handheld insertion instrument 35. At this stage, since the orifice inside the balloon catheter 47 generates a high flow resistance to water compared to the orifice of the open filling port 39, no liquid enters the balloon catheter 47.

[0197] Figure 15 shows the handheld insertion instrument 35 after the final preparation stage, in a state where the plug 40 is attached to the syringe barrel filling port 39 and the insertion instrument 35 is ready for use, that is, in the primary configuration. The interface between the syringe barrel 42 and the plug 40 may preferably be a screw-type Luer lock connection portion 50. The lock portion 48 between the plunger rod and the instrument body 36 has been removed to enable movement of the parts.

[0198] FIG. 16 shows a state where the balloon catheter 47, the plunger rod 43, and the syringe barrel 42 are pushed forward with respect to the instrument body 36, whereby the balloon catheter 47 advances forward so as to exit from the tip of the guide tube 37, that is, a handheld insertion instrument 35 in a secondary configuration. The balloon catheter 47 may be movable back and forth after removing the locking portion 48 between the instrument body 36 and the locking interface 51 of the plunger rod 43. In order to improve the grip of the instrument body 36 and facilitate the movement of the fingers for pushing and pulling, the finger engaging portions can be configured in various ways. For example, the finger engaging portions of the insertion instrument 35 may be a recess or surface for engagement by the thumb and one or two recesses or surfaces for engagement by the two fingers before holding the insertion instrument 35. During this stage, the liquid 49 is not injected from the syringe barrel 42 into the balloon catheter 20. This is because a considerably large force is required to push the resistance element 45 on the plunger rod 43 into the syringe barrel 42 compared to the force required to move the balloon catheter 47 in and out of the guide tube 37. When the balloon has advanced completely and the front portion of the plunger rod 43 collides with the innermost part of the instrument body 36 and the operator continues to apply force to the syringe barrel 42, the syringe barrel 42 moves beyond the resistance element 45 on the plunger rod 43, the liquid 49 is pushed into the balloon catheter 47, and at the distal end of the balloon catheter 47, the advanced balloon is inflated.

[0199] FIG. 17A shows the handheld insertion instrument 35 after injecting the liquid 49 from the syringe barrel 42 into the balloon catheter 47 for balloon inflation. A sharp element made of a hard material such as steel, for example, a blade or a pin, functions as a one-way lock 52 by cutting into the soft material of the syringe barrel 42. Such a locking method may be preferable because it can be locked at any position, in contrast to a ratchet lock with a limited number of lockable stages.

[0200] FIG. 17B is a detailed close-up view of the one-way lock 52 of the hand-held insertion instrument 35 according to the second embodiment.

[0201] FIG. 18 shows a second embodiment of the insertion instrument 35. FIG. 18 depicts another way to release the pressure within the balloon catheter 20, showing that the pressure is released by partially opening a plug 40 that seals the inlet 39 of the syringe barrel 42. In this embodiment, the operator slightly moves the thumb to press the lever of the plug 40 and rotates it, for example, 90 degrees to loosen the plug screw 50 and release the pressure within the syringe barrel 42. When releasing the pressure, a small amount of liquid 49 needs to be discharged from the filling port 39. To avoid spillage, the plug is configured to have a liquid collection reservoir 53. This method of releasing the pressure can reduce patient discomfort because there is no release of mechanical preloading elements, such as the release of a ratchet lock. Releasing a mechanically loaded lock is likely to cause a sudden noise or a sudden movement of the instrument parts, which is undesirable for an instrument that is partially placed within the patient's nose.

[0202] FIG. 19 is a perspective view of a type of hand-held insertion instrument 35 according to a type of the second embodiment. In this embodiment, the balloon guide tube 54 is composed of a flexible proximal portion 54 and a rigid distal portion 55. The rigid distal portion 55 has a bent tip 56 and means 57 for temporarily attaching to the distal cylindrical portion of any endoscope.

[0203] Figure 20 depicts the handheld insertion instrument 35 of this type of the second embodiment being attached to the rigid endoscope 58. This embodiment is advantageous for use with any rigid endoscope, whether digital or analog. Since the rigid endoscope 58 is an instrument that can be operated with one hand, the physician can operate the rigid endoscope 58, and thereby, by the attachment means 57, also operate the distal portion of the guide tube 55 with only one hand. The physician (operator) can advance and pressurize the balloon catheter 20 using the handheld insertion instrument 35 with the other hand. This embodiment can be a preferred solution for clinics using rigid endoscopes. This is because the hand movement for the insertion and pressurization instrument is completely separated from the part of the instrument located inside the nose. However, bundling the instruments in the nose may increase the discomfort of the patient.

[0204] Figure 21 is a side view of another type of handheld insertion instrument 35 of the second embodiment. In this embodiment, means for attaching and supporting a flexible endoscope or a rigid endoscope 64 are added. The open groove 65 on one side of the instrument functions as a flexible attachment part of the endoscope 64 to the instrument body 36 in combination with one or two rubber bands 63. The support mechanism enables at least rotation along the axis of the endoscope 64 itself and translation parallel to the axis of the endoscope 64 itself with respect to the instrument body 36 for adjusting the visual field during the procedure. The open groove 65 forms a linear track configured to support and guide a part of the cylindrical shaft of the rigid endoscope or the flexible endoscope.

[0205] The attachment means may be a separate rubber band 63 or, for example, a clip that can be closed. In this embodiment, the doctor can support the middle part of the endoscope 66 with the same hand that controls the insertion instrument 35. As a result, the other hand becomes completely free and can support the proximal end 60 of the analog flexible endoscope 64 or any endoscope. With this endoscope support structure, an inexpensive analog flexible endoscope can be used, and surgeries can be performed more widely even in private clinics where it is difficult to use a digital endoscope. Therefore, this endoscope support structure is a feature of the handheld insertion instrument 35. In order to cause as little discomfort to the patient as possible, the distal end of the endoscope 66 and the guide tube 37 must be arranged closely to minimize the perimeter of the part that enters the patient's nose from the nostril. This embodiment is shown with a bent guide tube 37. The guide tube 37 can have a soft S-shaped bend 68, for example, after exiting from the center of the instrument body 36, so that it is arranged parallel to and close to the middle part of the endoscope 66 supported on the side of the instrument body 36. Minimizing the total perimeter of the two instruments leads to reducing the pain and discomfort of the patient. Furthermore, co-guiding the two instruments leads to less pain and discomfort for the patient. This is because if the two instruments are handled separately by two different hands or two different operators, there may be a large relative movement between the two instruments. The flexible connection means between the two instruments is located at a position at least 100 mm from the distal end 59 of the guide tube 37. This flexible connection means allows torsion between the instruments and enables the two instruments to remain vertically above and below each other within the narrow horizontal nasal opening even when rotating the instrument assembly to find the opening of the eustachian tube. In this embodiment, the insertion instrument bends according to the nasal anatomy and soft tissue, rather than forcibly displacing the soft tissue as seen in embodiments where the instrument is tightly bundled at the distal end of the endoscope. For these reasons, this embodiment is more advantageous compared to the bundling examples of the instrument as seen in FIGS. 20 and US2018 / 0110407A1.

[0206] Figure 22 is a perspective view of this kind of hand-held insertion instrument 35 of the second embodiment. This kind of hand-held insertion instrument 35 according to the second embodiment has a pre-filled syringe ready for use inside the instrument body 36, and means for ensuring the correct pressure and means for locking and holding the pressure. The instrument body 36 further has alternative means for supporting the endoscope. One advantage of this second embodiment is that there is no preparation stage. The instrument can be used immediately after unpacking. The second advantage is that the method of ensuring the proper pressure inside the balloon is simpler throughout the procedure. The third advantage of this kind of hand-held insertion instrument 35 according to the second embodiment is that the attachment of the endoscope to the instrument body is more convenient and better positioning is possible throughout the operation.

[0207] FIG. 23 is a perspective view of a hand-held insertion instrument 69 according to the third embodiment. FIG. 23 depicts the hand-held insertion instrument 69 after the balloon 71 has been advanced and inflated. The interface 72 for placing the thumb is a component integrated with the drive member (manual actuator) 73 and may be, for example, a thumb ring as shown in the figure, or a thumb plate, or other suitable surface or recess along the thumb for applying a pressing force or a pulling force to the drive member 73. The drive member 73 is adapted to be pushed into the instrument body 70 to advance the balloon 71, subsequently inflate it, and finally pressurize it. The guide tube 74 is attached to the instrument body 70 via a guide tube connection portion 75 that functions as part of the instrument body 70. The instrument body 70 has a finger-rest interface 76 at the front of the instrument so that two fingers can provide a counterforce when the drive member 73 is pushed into the instrument body 70 using the thumb. The finger-rest interfaces at both the front and the rear enable pushing the drive member 73 into the instrument body 70 and pulling the drive member 73 out of the instrument body 70. The trigger 77 is located on the lower side of the instrument body 70 and serves to release the pressure of the balloon 71. This embodiment is intended to place the index finger on top of the guide tube 74 and the middle finger below the guide tube 74 at the two finger-rest interfaces 76 at the front of the instrument. The finger-rest interface 76 may be, for example, a finger ring, or a finger-rest plate 76 as shown in the figure, or other suitable surface or recess that enables the finger to apply a proximal or distal force to the instrument body 70. Also, it is intended that the ring finger can be used to press the trigger 77 after expansion to release the pressure. The endoscope support structure has a groove 78 provided along the instrument body 70 parallel to the guide tube 74 and a slot 79 provided in a finger-rest portion protruding from the instrument body 70. This support structure partially supports the endoscope such that the endoscope is fully supported only when the operator's finger is firmly placed on the finger-rest interface that presses the endoscope against the support structure.

[0208] FIG. 24 is a cross-sectional view of the hand-held insertion instrument 69 according to this third embodiment, showing the first stage and the first configuration in which the insertion instrument 69 is unpacked and ready for use. The drive member 73 having the thumb hook interface 72 is loosely fitted in the instrument body 70 and is guided to move linearly with respect to the instrument body 70. The instrument body 70 has means for preventing rotation such that the only possible movement is a translation parallel to the axis of the guide tube 74. The drive member 73 has an internal cylindrical cavity 80 that houses the metal coil spring element 81. The end of the plunger rod 82 fits into the cylindrical cavity 80. The shape of the end of the plunger rod 82 facing the spring 81 enables compression of the spring 81 and guidance within the cylindrical cavity 80. The other end of the plunger rod 83 is located within the syringe barrel 84 and is attached to a seal element 90 that seals the pre-filled liquid portion 85. The syringe barrel 84 is locked against any rotation and has guiding means for linearly moving within the instrument body 70 so that it can only translate parallel to the guide tube 74. The balloon catheter 86 is attached to the syringe barrel 84 via a catheter connection portion 87. The balloon catheter 86 is connected at a position offset from the center of the syringe barrel 84 such that the balloon catheter guide tube 74 can approach the side wall of the instrument body 70 as closely as possible. The trigger 77 is an integral part of the injection-molded instrument body 70 in this embodiment and has a thumb hook projection and a locking engagement shape 88 for interlocking with the drive member 73.

[0209] FIG. 25 shows a cross-sectional view of the hand-held insertion instrument 69 according to this third embodiment at a second stage where the drive member 73, the spring 81, the syringe assembly 89, and the balloon catheter 86 have advanced to the end stop position. This end stop position corresponds to the state where the balloon has advanced completely. This complete assembly can be advanced and retracted multiple times to extend and retract the balloon inside and outside the guide tube 74. The seal element 90 at the back of the plunger rod 83 has a high frictional force against the inner cylindrical wall of the syringe barrel 84, so that the assembly can be moved back and forth without causing premature inflation of the balloon due to the relative movement between the syringe barrel 84 and the plunger rod 83.

[0210] FIG. 26 shows a cross-sectional view of the hand-held insertion instrument 69 according to the third embodiment at a third stage. At this stage, the drive member 73, the spring 81, and the plunger rod 83 have advanced relative to the instrument body 70 and the syringe barrel 84, and as a result, the liquid 85 is discharged from the syringe barrel 84 and injected into the fully inflated balloon. Since the force required to fill the balloon is much smaller than the force required to compress the spring 81, the spring element 81 is not yet compressed.

[0211] Figure 27 shows a cross-sectional view of the handheld insertion instrument 69 according to the third embodiment at the fourth stage. At this stage, the drive member 73 has been moved further back relative to the instrument body 70. Since the balloon is fully inflated and non-flexible, the spring 81 is compressed. The drive member 73 is pushed into and moved within the instrument body 70 until it reaches a terminal stop (end stop) defined to obtain an appropriate pressure in the balloon. The trigger lock structure 88 engages with a counter lock 91 on the drive member 73. The external force applied by the operator can be released. The syringe barrel 84 is pre-filled with a liquid 85 of a known volume, and since the internal volume of the components is known, it is possible to define a predetermined spring force, and thus a predetermined balloon pressure, for a certain relative position of the drive member 73 with respect to the instrument body 70, resulting in a constant spring compression. The advantage of this solution is that a pressure gauge is not required. Since the liquid 85 is pre-pressurized by the spring element 81, the balloon pressure does not significantly decrease due to minor leakage or deformation of the components or tissues. As a result, during the surgery, the pressure is kept constant and there is no need to monitor or readjust the pressure. After successfully dilating the anatomical passage, the operator can apply pressure to the drive member 73 using the thumb and then pull the trigger 77 to release the lock structure 88 from the counter lock 91, thereby releasing the pressure inside the balloon.

[0212] Figure 28 is a side view of the handheld insertion instrument 69 according to this third embodiment in combination with an analog flexible endoscope 92.

[0213] Figure 29 is a perspective view of the handheld insertion instrument 69 according to the third embodiment in combination with an analog flexible endoscope 92. Support features on the instrument body such as the groove 78 and the slots of the protruding finger hook interface 79 are not sufficient to support the endoscope. In fact, the endoscope is fully supported only when the operator holds the insertion instrument and presses at least a part of the endoscope against the groove 78. The operator may adjust the force applied to a part of the endoscope to enable some adjustment of the position of the endoscope 92 during the procedure.

[0214] Figure 30 is a side view of the hand-held insertion instrument 69 according to the third embodiment, combined with the digital rigid endoscope 93. The operator can operate the insertion instrument with one hand and support and adjust the proximal part of the endoscope 94 with the other hand.

[0215] Figure 31 is a perspective view of the hand-held insertion instrument 69 according to the third embodiment, combined with the rigid endoscope 93. The endoscope support groove 78 is provided on both the instrument body 70 and the drive member 73 so that the thumb can support the weight of the proximal part of the rigid endoscope when the operator needs to temporarily free one hand. The endoscope support groove 78 forms a linear track configured to support and guide a part of the cylindrical shaft of the flexible endoscope 92.

[0216] Figures 32 - 35 show a fourth embodiment of the first aspect of the hand-held insertion instrument 95. This fourth embodiment has many similarities with the third embodiment, but is based on an internal gas spring system and has alternative endoscope support means.

[0217] Figure 32 is a perspective view of the hand-held insertion instrument 95 according to this fourth embodiment in its initial stage. The insertion instrument 95 is unpacked and ready for use. The endoscope support means on the instrument body 96 is provided as two slots 97 of two protruding finger hooks 98 arranged on the guide tube 99. Similar to the previous embodiments, the endoscope is fully supported only when the operator firmly grasps the instrument and presses a part of the endoscope against the bottom surface of the slot 97 with a finger. One slot may be made larger than the other to allow for a slight angular movement of the endoscope. The drive member 100 having an alternative thumb hook interface 101 is loosely fitted into the instrument body 96 having guide means for linear translational movement with respect to the instrument body 96, and only translational movement parallel to the guide tube 99 is possible.

[0218] Figure 33 is a cross-sectional view of the handheld insertion instrument 95 according to this fourth embodiment. The insertion instrument 95 is in a ready-to-use state. The drive member 100 is attached to the proximal portion of the plunger rod 102 within the insertion instrument 95. Thereby, the force of the operator is transmitted via the drive member 100 and the plunger rod 102 to the rear seal element 107 at the distal end of the plunger rod 102. The distal end of the plunger rod 102 is located within the syringe barrel 104. The syringe barrel 104 is disposed inside the instrument body 96 and has guiding means for linearly translating relative to the instrument body 96. The balloon catheter 105 is mounted directly to the distal end of the syringe barrel 104. Inside the syringe barrel 104 are two movable seal elements.

[0219] The front seal element 106 is disposed on the side of the balloon catheter 105, and the rear seal element 107 is disposed on the side of the plunger rod 102. Inside the syringe barrel 104, there is an accurately pre-filled amount of liquid between the front seal element and the attached balloon catheter. Air 108 is enclosed between the two seal elements, and the enclosed air 108 acts as a gas spring. This gas spring provides a spring biasing force that acts on the front seal element 106 when the plunger rod 102 and the rear seal element 107 have advanced to the locked position relative to the instrument body 96. A small vent hole 110 may be provided as close as possible to the rear seal element 107. This vent hole is for preventing a negative or positive pressure from being generated in the enclosed air 108 as a function of temperature change before use of the instrument. When the rear seal element 107 moves beyond the vent hole 110, the space between the front and rear seal elements is sealed, and the enclosed air 108 can be compressed as a spring element.

[0220] FIG. 34 is a cross-sectional view of the hand-held insertion instrument 95 according to the fourth embodiment at the second stage. At this stage, the drive member 100, the plunger rod 102, the syringe barrel 104, the rear seal element 107, and the front seal element 106, as well as the balloon catheter 105 as an assembly, have all been moved from the first position to a recognizable end stop position. This end stop position is in the second position corresponding to the fully advanced balloon. Since the protruding bump 111 of the plunger rod 102 protrudes outside the inner diameter of the syringe barrel 104, a considerably large force is required for the drive member 100 to further push the plunger rod 102 into the syringe barrel 104 for balloon inflation. The entire assembly can be pushed and pulled several times with respect to the instrument body 96 by the operator before inflating the balloon. The protruding bump 111 of the plunger rod 102 needs to undergo a deformation that requires a considerably large force when further moving the plunger rod 102 into the syringe barrel 104.

[0221] FIG. 35 shows a cross-sectional view of the hand-held insertion instrument 95 according to the fourth embodiment at the third stage. At this stage, the drive member 100, the plunger rod 102, and the two seal elements 106, 107 have advanced with respect to the syringe barrel 104 to positions corresponding to the fully inflated balloon and the fully pressurized balloon.

[0222] At this position, the amount of liquid required for inflation is injected into the balloon, and the enclosed air 108 is compressed. The operator pushes the drive member 100 into the instrument body 96 until it geometrically stops firmly. When the drive member 100 is released, the drive member 100 can return slightly to the locked position where the lock 112 between the instrument body 96 and the drive member 100 engages. The volume 108 of the enclosed air has decreased corresponding to the pressure required within the balloon. For example, the volume of air is compressed to 1 / 10 of its original volume corresponding to a pressure increase from 1 bar to 10 bar. The lock 112 holds the drive member 100 in a locked state at a predetermined position relative to the instrument body 96. After successful dilation of the anatomical passage, the operator may release the lock 112 using the trigger 113.

[0223] FIG. 36 is a graph showing the relationship between the force applied to the drive member and the distance the drive member moves relative to the instrument body, and describes both the third and fourth embodiments of the hand-held insertion instrument. To initially move the drive member to advance the balloon, a certain force f1 must be overcome. The force f1 is desirably as small as possible and is mainly the friction between components. The operator may move the drive member back and forth between s1 and s2. To further move the drive member relative to the instrument body, thereby starting to move the plunger and the seal element relative to the syringe barrel and causing the balloon to inflate, a force greater than f2 must be applied. The force f2 is mainly given by the friction of the seal element within the syringe and the deformation of deformable elements such as protruding bumps. When the balloon inflates completely without receiving great resistance, the distance s2 is reached. The movement of the drive member beyond s4 is geometrically limited, whereby the force f4 becomes the maximum force that the operator can apply to the inner seal element within the syringe barrel. Thus, the operator cannot accidentally exceed the allowable pressure of the balloon. When the operator releases the drive member, the drive member returns slightly to the distance s3 of the locked position and becomes the force f3. In this case, the force f3 is applied only by the internal spring element of the instrument, and the f3 applied to the seal element within the syringe barrel supplies the necessary pressure within the balloon. Small leaks or small deformations of components or tissues that increase the internal pressurized volume cause only a slight pressure drop because the system has a spring element and low rigidity. In contrast, in FIG. 10, which described the first embodiment of the hand-held insertion instrument, there is no spring element, the rigidity of the system is very high, and any small deformation that leads to an increase in the internal volume causes a significant pressure drop, requiring pressure monitoring and readjustment.

[0224] FIGS. 37 through 42 show a hand-held insertion instrument 114 according to the fifth embodiment. In this embodiment, for bilateral surgery on a single patient, multiple spring return functions are integrated for ergonomic improvement and excellent reusability of the insertion instrument.

[0225] FIG. 37 is a perspective view of the hand-held insertion instrument 114 according to this fifth embodiment. It shows the state at the first stage when the insertion instrument is unpacked and ready for use. In this instrument, the internal syringe assembly is pre-filled with water and no preparation stage is required. This instrument has an alternative form of support means that does not pass through holes or slots for supporting the endoscope on the instrument body. This support means employs an open slot 115 as part of a finger hook interface 116 disposed above the guide tube 117 for more quickly and conveniently positioning the endoscope. A plunger rod 118 having a thumb hook interface 119 is configured to be fixed and guided for linear translational movement into the instrument body 120 for the advancement, inflation, and pressurization of the balloon.

[0226] FIG. 38 is a perspective view of the hand-held insertion instrument 114 according to the fifth embodiment in combination with a rigid endoscope 121. The endoscope 121 is not sufficiently supported only by the support means of the hand-held insertion instrument 114. However, when the operator firmly grasps the instrument 114 so as to press a part of the endoscope against the instrument body and the bottom of the opening slot 109, the endoscope is fully supported. The operator may operate the insertion instrument 114 with one hand and support and adjust the rigid endoscope 121 with the other hand. The open slot 109 forms a linear track configured to support and guide a part of the cylindrical shaft of the rigid endoscope 121.

[0227] FIG. 39 is a perspective view of the hand-held insertion instrument 114 according to the fifth embodiment in combination with an analog flexible endoscope 122. The endoscope 122 is not sufficiently supported only by the endoscope support means of the insertion instrument 114. However, when the operator firmly grasps the insertion instrument 114 so as to press a part of the endoscope against the instrument body and the bottom of the opening slot 109, the endoscope 122 is fully supported. The operator may operate the insertion instrument 114 with one hand and support and adjust the proximal portion of the flexible endoscope 123 with the other hand.

[0228] FIG. 40 is a cross-sectional view of the hand-held insertion instrument 114 in the first stage according to this fifth embodiment.

[0229] The insertion instrument 114 is unpacked and ready for use. The double syringe barrel body 124 disposed inside the instrument body 120 has guiding means for precisely translating relative to the instrument body 120 parallel to the axis defined by the cylindrical guide tube 117. This guiding means may include fitting or tightly fitting the double syringe body 124 snugly inside the instrument body 120. The double syringe barrel body 124 has an upper syringe barrel 125 pre-filled with a predetermined amount of water for balloon pressurization and a lower gas spring syringe barrel 126. The gas spring syringe barrel has a gas spring plunger rod 127. The gas spring plunger rod 127 is connected to and held by a rear end structure 128 connected to the rear end of the instrument body 120. The gas spring assembly provides a spring return function such that the operator does not need to pull back the drive member for balloon retraction. When the direction of the force changes when pushing or pulling the drive member, the entire instrument will move, causing discomfort to the patient. Also, when the instrument does not fit well with the size of the operator's hand, it may be difficult to perform the pulling-back operation with the thumb. For these reasons, it is much better for the operator and the surgery if the drive member has a spring return function. As shown in this embodiment, the gas spring 126 is configured to be a vacuum gas spring. This is because the vacuum gas spring provides favorable characteristics as a spring. The upper syringe barrel 125 includes a front spring 129, a seal element 130, and a rear spring 131. The plunger rod 118 has a connection portion 132 facing the rear spring 131 and transmits the force applied by the operator to one end of the rear spring 131. In the assembled and prepared instrument, the springs 129, 131 are pre-tensioned by the plunger rod 118. The plunger rod 118 is held at a position relative to the double syringe barrel 114 where it can pre-tension these springs.The force required to fully retract the gas spring 126 is significantly smaller compared to the force required to further compress the pre-tensioned springs 129, 131. The front spring 129 is much softer compared to the rear spring 131.

[0230] Figure 41 is a cross-sectional view of the handheld insertion instrument 114 according to this fifth embodiment at the second stage.

[0231] At this stage, the plunger rod 118 and the double syringe barrel body 124 assembly are advanced towards the end position. This end position corresponds to the state where the balloon has fully advanced. A vacuum space 133 is formed within the gas spring syringe 126. Thus, when the plunger rod 118 is released, the assembly retracts and the balloon retracts. This may be repeated several times until the balloon advances to the correct position.

[0232] Figure 42A is a cross-sectional view of the handheld insertion instrument 114 according to this fifth embodiment at the third stage.

[0233] At this stage, the plunger rod 118 is pushed into the end stop position. At the end stop position, the balloon is fully inflated and pressurized, and both the front spring 129 and the rear spring 131 are compressed. The operator can at any time release the force on the plunger rod 118 and return to the previous stage. As the compression force is gradually released, the stiffest spring in the system always extends first. When the force is released, the rear spring 131 extends and the pressure in the balloon decreases. When the force is further released, the front spring 129 extends and pushes back the seal element 130, extracting liquid from the balloon. When the force is further released, the gas spring 126 returns to its original position and pulls back the balloon. In order for the balloon to enter the guide tube again, it is necessary to fully contract the balloon. Therefore, it is important to contract the balloon before attempting to fully contract it.

[0234] Figure 42B is a cross-sectional view of the handheld insertion instrument 114 according to the fifth embodiment at the fourth stage.

[0235] At this stage, the plunger rod 118 is locked in its final position relative to the instrument body 120. In this embodiment, the locking function 134 requires the operator to move the plunger 118 slightly downward to shift its position to an angle where it can be interlocked with an end cap 135 firmly connected to the instrument body 120. To release the plunger rod 118, the operator may push and shift the plunger rod 118 upward. If the operator has to press the spring-loaded plunger rod 118 before unlocking, there will be no sudden release of energy that causes sudden movement or a sudden sound.

[0236] FIG. 43 is a graph showing the relationship between the force applied to the plunger rod and the movement distance of the plunger rod relative to the instrument body, and describes a fifth embodiment of the hand-held insertion instrument. The initial force f1a is necessary to start the movement of the plunger rod, and with the gas spring, the required force gradually increases as a function of the spring stiffness. To reach the position s1 where the balloon fully advances, the force f1b is required. For further movement, a larger force f2a is required. The difference between f1b and f2a functions as a tactile feedback to inform the operator that the balloon has fully advanced and to prevent the balloon from inflating prematurely. The operator may release the force on the plunger rod and retract the balloon at any time. When the force f2a is applied, the inflation of the balloon is started, but for further movement, it is necessary to compress the front spring element, and the required force becomes a function of the stiffness of the front spring. When the force f2b is applied to the plunger rod, the drive member moves to the position s2, and the balloon fully inflates but is not pressurized. When further force is applied, the pressurization of the balloon is started, and at the position s4 and the force f4, the plunger rod is at the end position and cannot move further. This functions as a safety precaution to avoid balloon rupture. When the operator returns the plunger rod to the lock position s3, the correct force f3 supplies the correct pressure into the balloon. After successful expansion, the operator may release the lock of the plunger rod and gradually release the force. Then the balloon decompresses, shrinks, and is retracted. This procedure can be conveniently and quickly repeated for the opposite side of the same patient or for other anatomical passages. All other prior art instruments are made for single-sided procedures only and cannot be easily reused.

[0237] Figures 44 to 47 show a sixth embodiment of the handheld insertion instrument. In this embodiment, the syringe barrel and the instrument body are integrated, resulting in the most compact and low-cost instrument design. This insertion instrument is provided with a unique hydraulic lock that prevents premature balloon inflation during balloon advancement and retraction. The insertion instrument of this embodiment can be combined with an endoscope support structure as seen in other embodiments. Also, similar to other embodiments, it can be combined with a spring element to avoid a pressure gauge and a ratchet lock.

[0238] Figure 44 is a perspective view of the handheld insertion instrument 136 according to this sixth embodiment. It shows the instrument in the initial stage when it is unpacked and ready for use. The instrument body 137 has a threaded connection portion for attaching the pressure gauge 138. The instrument body 137 has a ring-shaped finger hook interface 139 for two fingers. The guide tube 140 is firmly fixed to the front surface of the instrument body 137. The plunger rod 141 is connected at its proximal end to a ring-shaped thumb hook interface 142. At the distal end, on the other hand, it holds a seal element that seals against the inside of the integrated syringe barrel within the instrument body 137. The lock element 143 is firmly attached to the end of the instrument body, serves the purpose of guiding the plunger rod 141, and has a ratchet lock interface 144 for the plunger rod 141.

[0239] FIG. 45 is a cross-sectional view of the handheld insertion instrument 136 according to this sixth embodiment in a first stage. The insertion instrument is unpacked and ready for use and is in its primary configuration. Inside the instrument body 137, there is a cylindrical cavity that functions as an integrated internal syringe barrel 145. The plunger rod 141 has a seal element 146 for sealing within the syringe barrel 145. The proximal end of the balloon catheter 147 is directly connected to a double seal element 148 disposed within the internal syringe barrel 145. The double seal element 148 has two seal rings, a rear seal ring 149 located on the side of the plunger rod and a front seal ring 150 located on the side of the guide tube. A fluid connection channel 151 disposed between the two seal rings connects the outer periphery of the seal element 148 and the lumen of the balloon catheter 147. In this first stage, there is a pre-filled liquid 152 between the seal element 146 of the plunger rod and the double seal element 148. This narrow space is completely closed and sealed from the surrounding air. Since force is transmitted through the non-compressible pre-filled liquid 152, any movement of the plunger rod 141 results in a corresponding movement of the double seal element 148 and, in turn, a corresponding movement of the balloon catheter 147.

[0240] FIG. 46 is a cross-sectional view of the handheld insertion instrument 136 according to the sixth embodiment at the second stage. At this stage, the insertion instrument 136 is in the secondary configuration, and the plunger 141 is pushed into the instrument body 137 until the double seal element 148 reaches the end stop at the bottom of the inner syringe barrel 145, and the balloon has advanced completely. At this position of the double seal element 148, since the rear seal ring 149 passes through the groove 153 on the inner wall of the inner syringe barrel 145, the pre-filled liquid 152 can flow from the space between the plunger seal 146 and the rear seal ring 149 into the fluid connection channel 151 of the double seal element 148, and further into the lumen of the balloon catheter 147. In fact, when the double seal element 148 is in the innermost position, the liquid 152 is connected to the balloon catheter 147, and when the plunger rod 141 is further pushed in, the balloon is filled with the liquid. In the previous embodiment, a difference in applied force was used as a method to avoid premature filling of the balloon during the movement of the balloon. In this embodiment, a hydraulic lock is used to prevent the balloon from being filled before it has advanced completely. In manufacturing, it may be advantageous to combine the position of the groove 151 with the screw interface for the pressure gauge 138.

[0241] FIG. 47 is a cross-sectional view of the handheld insertion instrument 136 according to the sixth embodiment at the third stage. At this stage, the insertion instrument 136 is in the tertiary configuration, and the plunger rod 141 has advanced to the final position where the balloon is fully inflated and pressurized. The ratchet interface 144 and the lock element 143 on the plunger rod 141 lock the position of the plunger 141 relative to the instrument body 137 and hold the pressure throughout the procedure. The operator can monitor the pressure and readjust the pressure as needed. To release the ratchet lock, the plunger 141 may be rotated 90 degrees. In this embodiment, the insertion instrument is not reusable.

[0242] FIG. 48 is a perspective view of a hand-held insertion instrument 155 according to a seventh embodiment similar to the fifth embodiment. This hand-held insertion instrument includes an illumination guide wire 156 used to confirm the position before the balloon advances and expands. Such a feature of having such a guide wire 156 is considered favorable for the dilation of any paranasal sinus passage. In such an embodiment, the operator first advances the guide wire 156 into the paranasal sinus for position confirmation, and then, before the balloon is inflated and pressurized, advances the balloon and positions it around the guide wire 156. The guide wire of the insertion instrument is well-known and widely used, but when used in paranasal sinus dilation, it can be considered an essential and unique part of the fully integrated hand-held insertion instrument 155. The guide wire 156 may also be combined with the previously described embodiments.

[0243] FIG. 49 is a perspective view of a hand-held insertion instrument 157 according to an eighth embodiment similar to the fifth embodiment. In this embodiment, the instrument body 158 has an integrated digital endoscope 159. The integrated digital endoscope 159 has an image sensor 160 disposed near the tip of the guide tube 161 and a cabled plug 162 extending from a part of the instrument body 158. The cable 162 is for connecting to a digital monitor. The integration of the digital endoscope 159 can be combined with the insertion instruments according to any of the previously described embodiments.

[0244] Figure 50A is a perspective view of a hand-held insertion instrument 164 according to the ninth embodiment. An instrument body 165 is coupled to a guide tube 166. A slider 167 disposed in the instrument body 165 is connected to an internal balloon catheter, and the balloon catheter is advanced to a forward position where it exits the guide tube 166 by forward movement of the slider 167. The proximal end of the balloon catheter 168 extends out of a hole in the instrument body 165 and has a connection portion 169 for connection to an external pressurizing instrument. An open groove 170 is formed in the instrument body 165 along one side surface of the instrument body 165 parallel to the guide tube 166 to partially support an endoscope. This open groove 170 is "V"-shaped in this example and has a depth that supports at least the lower 1 / 3 of a cylindrical element having a diameter of 3-4 mm, such as the thin cylindrical flexible portion of a flexible endoscope or the thin cylindrical rigid portion of a rigid endoscope. The open groove forms a linear track configured to support and guide a part of the cylindrical shaft of a rigid or flexible endoscope. However, other shapes and sizes may also be possible.

[0245] Figure 50B is a perspective view of the hand-held insertion instrument 164 according to this ninth embodiment, depicting an endoscope 171 disposed in the open groove 170 of the instrument body 165. The endoscope is not fully supported only by the open groove 170 of the instrument body 165, but it will be apparent that the endoscope is fully supported when the operator firmly holds the instrument body 165 with one hand, presses a part of the thin cylindrical portion of the endoscope 171 against the open groove 170, and supports the proximal portion of the endoscope with the other hand. An assistant can operate a separate pressurizing instrument connected thereto.

[0246] FIG. 51A is a perspective view of a hand-held insertion instrument 164 according to the ninth embodiment, but includes other means for supporting an endoscope. An instrument body 173 is coupled to a guide tube 174. A slider 175 disposed on the instrument body 173 is connected to an internal balloon catheter, and the balloon catheter is advanced to a forward position where it exits the guide tube 174 by moving the slider 175 forward. The proximal end of the balloon catheter 176 extends through a hole in the instrument body 173 and has a connection portion 177 for connection to an external pressurizing instrument. The instrument body 173 has a tubular hole 178 disposed on the upper surface of the distal end and directed toward the guide tube 174. The tubular hole in this example is 5 mm wide, 10 mm high, and 25 mm long, but the tubular hole may have other sizes and shapes. The most important thing is that the width of the tubular hole is wider than 4 mm, the height is higher than 4 mm, and the length is longer than 10 mm. The thin cylindrical portion of a flexible endoscope or a rigid endoscope may be inserted into the tubular hole to partially support the endoscope. The tubular hole is larger than the thin cylindrical portion of an endoscope with a diameter of 3-4 mm and cannot fully support the endoscope. The length of the tubular hole gives an angular limitation to the endoscope and keeps it parallel to the guide tube. The operator can insert the endoscope through the tubular hole to a desired position where the field of view covers the tip of the guide tube 174, and while pressing a part of the endoscope against the upper surface 179 of the instrument body 173 with one or more fingers or a part of the hand to fully support the endoscope at the desired position, the instrument body can be held with one hand. The tubular hole forms a straight track configured to support and guide a part of the cylindrical shaft of a rigid or flexible endoscope.

[0247] FIG. 51B is a perspective view showing one kind of the ninth embodiment, but it is provided with other means for supporting an endoscope. An instrument body 181 is coupled to a guide tube 182. A slider 185 disposed on the instrument body 181 is connected to an internal balloon catheter, and the balloon catheter is advanced to a forward position where it exits the guide tube 182 by moving the slider 185 forward. The proximal end of the balloon catheter 183 extends out of a hole in the instrument body 181 and has a connection portion 184 for connection to an external pressurizing instrument. The instrument body 181 has two forks 186 disposed at an interval of about 50 mm, and the forks have a central gap with a width of 5 mm. A thin cylindrical portion of a flexible endoscope or a rigid endoscope may be disposed in the gap between the two fingers of the forks so that the tip of the endoscope is adjacent to the tip of the guide tube 182. The operator may dispose the endoscope between the two fingers of the two forks at a desired position such that the field of view covers the tip of the guide tube 174, and the operator can hold the instrument body with one hand while pressing a part of the endoscope against the upper surface 187 of the instrument body 181 with one or more fingers or a part of the hand to completely support the endoscope at the desired position. The two forks 186 form a linear track configured to support and guide a part of the cylindrical shaft of a rigid endoscope or a flexible endoscope.

[0248] FIG. 52A is a perspective view of a hand-held insertion instrument according to the tenth embodiment. A balloon insertion instrument 188 has an instrument body 189 coupled to a guide tube 190 into which a balloon catheter 195 is inserted. A forward drive member 191 connected to a thumb interface 192 is partially disposed inside the instrument body 189 and is connected to the balloon catheter 195 for advancing and retracting the balloon catheter 195. A fluid connection port 193 protrudes from the instrument body 189 through a slot 194 in the instrument body 189.

[0249] FIG. 52B shows a cross-sectional view of the hand-held insertion instrument according to the tenth embodiment at a first stage, and the balloon in the first position is drawn into the guide tube 190. The forward drive member 191 has a sealing element 198 (e.g., an O-ring) that seals against the cylindrical internal cavity 202. The forward drive member further seals against a sealing element 200 (e.g., an O-ring) held in place by an end cap 199. The enclosed space 201 is sealed by the two seals 200 and 198. The balloon catheter 195 is connected to the forward drive member 191 by a proximal connection portion 196. The guide tube 190 is connected to the instrument body 189 via a front cap 197.

[0250] FIG. 52C shows a cross-sectional view of the hand-held insertion instrument 188 according to the tenth embodiment at a second stage, and the balloon in the second position has exited the guide tube 190 and is fully advanced. The forward drive member 191 is pushed in until it reaches an end stop in order to fully advance the balloon catheter 195. Accordingly, since the sealed space 201 has increased in size, the pressure is much lower than the ambient pressure. When the force applied to the forward drive member 191 is released, as a result of the pressure difference on the left and right of the sealing element 198, the drive member 191 and the balloon catheter 195 retract. It is convenient that the balloon can be retracted without having to pull it with the thumb. This solution provides a less uncomfortable procedure because the act of repeatedly pushing and pulling the insertion instrument may lead to moving the instrument partially placed inside the nose within the nose.

[0251] FIG. 53A shows a handheld insertion instrument 200 according to the 11th embodiment. In this embodiment, the instrument body 202 includes a static handle 206 that is integral with the instrument housing 202 for engagement by one or more fingers of the operator, and a longitudinally displaceable handle 208 that is coupled to components inside the instrument body 202. The balloon catheter guide tube 204 extends from the instrument body 202 as an oval-shaped extension of the instrument body 202. The distal end (tip) 205 of the balloon catheter guide tube 204 is shown bent, but it should be understood that the tip 205 of the balloon catheter guide tube may be straight. In FIG. 53A, the handheld insertion instrument 200 is in a primary configuration in which the balloon catheter 20 is within the catheter guide tube 204.

[0252] FIG. 53B shows the handheld insertion instrument 200 according to the 11th embodiment, in which the inflatable portion of the balloon catheter 20 protrudes from the distal end of the insertion instrument but is not inflated. The longitudinally displaceable handle 208 is pushed forward to an intermediate position by the operation of the operator's thumb, whereby the inflatable portion of the balloon catheter 20 is pushed out of the catheter guide tube 204. In FIG. 53B, the handheld insertion instrument 200 is in a secondary configuration. That is, the inflatable portion on the distal side of the balloon catheter 20 protrudes from the catheter guide tube 204.

[0253] FIG. 53C shows the handheld insertion instrument 200 of FIG. 53B, in which the inflatable portion of the balloon catheter 20 protrudes from the distal end of the insertion instrument and is inflated, and is in a tertiary configuration. The inflatable portion of the balloon catheter 20 is inflated when the operator pushes the longitudinally displaceable handle 208 forward from the intermediate position.

[0254] FIG. 54A is a cross-sectional view of the handheld insertion instrument 200 in the primary configuration shown in FIG. 53A. The longitudinally displaceable handle 208 is in the fully retracted position and projects from the instrument body 202 through the elongated slit 219. The longitudinally displaceable handle 208 is connected to the plunger rod 212 via a second locking mechanism 230, which in turn acts on the helical spring 211. The longitudinally displaceable syringe barrel 214 is received within the instrument body 202. In this embodiment, a seal element 215 is provided that sealingly engages the inner surface of the syringe barrel 215 with respect to the plunger rod 212. The plunger rod 212 is in the longitudinal position range of the syringe 214 with respect to the instrument housing barrel in which relative movement with respect to the syringe barrel 214 is blocked by a first locking mechanism 220 (shown in detail in FIGS. 55A-C). The pressure relief valve 207 limits the maximum pressure within the syringe barrel. This will be explained in more detail later.

[0255] FIG. 54B is a cross-sectional view of the handheld insertion instrument 200 in the secondary configuration shown in FIG. 53B. The longitudinally displaceable handle 208 is being pushed by the operator's action on the handle 208 and is moving to an intermediate position. The syringe barrel 214 is locked to the plunger rod 212, and the plunger rod 212 is connected to the longitudinally displaceable handle 208 via a helical spring 211. Thus, the syringe barrel 214 is moving integrally with the plunger rod 212 toward the distal end of the handheld insertion instrument 200. Since the proximal end of the balloon catheter 20 is connected to the distal end of the syringe barrel 214, the balloon catheter 20 advances, and the inflatable portion of the balloon catheter 20 protrudes from the tip of the catheter guide tube 204. At this position of the syringe barrel 214 relative to the instrument body 202, the first locking mechanism 220 no longer prevents relative movement between the plunger rod 212 and the syringe barrel 214. Thus, when the operator further pushes the longitudinally displaceable handle 208 toward the distal end of the handheld insertion instrument 200, the plunger rod 212 moves into the syringe barrel 214, pushing the water in the syringe barrel into the balloon catheter 20, thereby inflating the balloon catheter 20. This is shown in FIG. 54C, and the handheld insertion instrument 200 is transitioning to the tertiary configuration.

[0256] Figure 55A shows the first locking mechanism 220 in more detail with the handheld insertion instrument 200 in its primary configuration. The locking member 222, which is a ball-shaped locking member in this embodiment, is received within the radial bore of the syringe barrel 214, and a portion of the locking member 222 protrudes into the annular groove of the plunger rod 212. At all positions of the syringe barrel 214 relative to the instrument body 202 except for one longitudinal position, the locking member 222 cannot disengage from the annular groove of the plunger rod 212. However, when the syringe barrel 214 is fully advanced to the distal end of the instrument body 202, the position of the locking member 222 aligns with the recess 224 of the instrument body 202. Then, the locking member 222 can move radially outward of the instrument body 202 and can disengage from the annular groove of the plunger rod 212 as shown in Figure 55B. Figure 55C shows the locking member 222 moving radially outward, thereby releasing the lock of the plunger rod 212 from the syringe barrel 214 and allowing the plunger rod 212 to move within the syringe barrel 214 to inject water within the syringe barrel 214 into the balloon catheter 20 and inflate the balloon catheter 20.

[0257] When the plunger rod 212 is retracted from the position shown in Figure 55C, because the recess 224 is angled proximally, when the annular groove of the plunger rod comes into axial alignment with the locking member 222 and the recess 224 (see Figure 55B), the locking member 222 re-engages and is thereby pushed into the annular groove of the plunger rod 212. For further retraction of the piston rod 212, the syringe barrel 214 moves integrally with the piston rod 212 as shown in Figure 55A, whereby the inflatable portion of the balloon catheter 22 is retracted into the catheter guide tube 204. Thus, the syringe barrel 214, and thus the balloon catheter 20, cannot be retracted before the balloon contracts, thereby preventing damage to the inflatable portion of the balloon catheter 20.

[0258] FIG. 56A is a perspective view of the instrument body 202. FIG. 56B is a perspective view of the syringe barrel 214 with the longitudinally displaceable handle 208, the plunger rod 212, and the balloon catheter 20 connected to the distal end of the syringe barrel 514, and is a primary configuration diagram with the plunger rod 212 fully retracted. In FIG. 56C, the plunger rod 212 is fully inserted into the syringe barrel 214. The second locking mechanism 230 has a first cylindrical cam body 231 that moves integrally with the longitudinally movable handle 208. The first cylindrical cam body 231 is preferably integrated with the handle 208. The first cylindrical cam body 231 interacts with a second cylindrical cam body 232. The second cylindrical cam body 232 has a common axis with the first cylindrical cam body 231 and is rotatable about the common axis. The first cylindrical cam body 231 includes a plurality of cam surfaces that interact with a plurality of cam surfaces of the second cylindrical cam body 232, and imparts a one-way rotational movement to the second cylindrical cam body 232. Both the first cylindrical cam body 231 and the second cylindrical cam body 232 are provided with three axial slits preferably distributed at equal intervals in the circumferential direction on their outer surfaces. These slits interact with three axially extending axial ribs 217 that extend longitudinally inwardly in the bore in the instrument body 202 in which the cam bodies 231, 232 are received. The three axially extending axial ribs 217 prevent the second cylindrical cam body 232 from rotating until it passes the distal end of the rib 217. When the second cylindrical cam body 232 passes the distal end of the rib 217, it is when the longitudinally movable handle 208 is in its most forward position, i.e., in the tertiary configuration as shown in FIG. 56C. The one-way rotational movement of the second cylindrical cam body 232 relative to the first cylindrical cam body 231 switches the second locking mechanism 230 between a locked state and an unlocked state. And the helical spring 211 biases the second cylindrical cam body 232 toward the first cylindrical cam body 231. FIG. 56D shows a state in which the second cylindrical cam body 232 has rotated to the locked angular position. The locking element has rotated to the locked angular position. In the locked state, the second locking mechanism 230 prevents the second cylindrical cam body 232 from moving proximally from its distal position. Accordingly, the plunger rod 212 is continuously pushed via the helical spring 211.And in the unlocked state, the second locking mechanism 230 allows the second cylindrical cam body 232 and thus the plunger rod 212 to move proximally from its distal position, enabling the balloon catheter 20 to contract and retract. When the operator fully presses the longitudinally movable handle 208 forward so that the handheld insertion instrument 200 is in the tertiary configuration, the second locking mechanism 230 is automatically locked, thereby maintaining the pressing force on the plunger rod 212 via the helical spring 211. The helical spring 211 assists in substantially maintaining the pressure within the balloon catheter 20. When the operator presses the longitudinally movable handle 208 again, the second cylindrical cam body 232 rotates again, thereby moving the second locking mechanism 230 to the unlocked state and enabling the plunger rod 212 to be retracted.

[0259] The longitudinal groove 213 depicted in FIG. 56A provides a track for guiding an elongated cylindrical object along the length of the handheld insertion instrument 200, such as an insertion tube, a flexible endoscope, or a rigid endoscope.

[0260] FIG. 56D is a cross-sectional view of the instrument body 202, showing internal longitudinal axial ribs 217 spaced 120° apart within the bore in which the cylindrical lock components 231 and 232 are guided, and a longitudinal slit 219 within the instrument to allow the longitudinally movable handle 208 to penetrate into the instrument body 202 and connect to the first cylindrical lock component 231.

[0261] FIG. 57 is a detailed cross-sectional view showing a state where the distal end of the syringe barrel 214 is in the rearmost position within the instrument body 202, that is, a state where the handheld insertion instrument 200 is in the three-piece configuration. The pressure relief valve 207 prevents overexpansion of the balloon catheter 20. In the present embodiment, since there is only one locking position of the plunger rod 202 in the axial direction and there is no pressure gauge, the axial tolerances of the components, the stiffness tolerances of the springs, the tolerances of the balloon size, and the filling tolerances of the water affect the final pressure within the balloon catheter 20. By using the pressure relief valve 207 set to the balloon operating pressure and the syringe barrel 214 intentionally overfilled, the need for strict tolerances is eliminated or at least reduced. Until the second locking mechanism 230 engages, water is continuously discharged through the pressure relief valve 207, for example, at 10 bar. The pressure relief valve 207 has a spring-loaded ball-shaped valve member 234 in the present embodiment and limits the maximum pressure within the syringe barrel 214. The spring, a helical spring 232 in the present embodiment, biases the spring-loaded valve member 234 against a valve seat formed in the syringe barrel 214, and an adjustment screw 237 provided at the end of the helical spring 232 opposite to the valve member 234 enables adjustment of the pressure at which the relief valve 207 opens. Accordingly, it is avoided that an operator applies an excessive force to the longitudinally displaceable handle 208 to overpressurize.

[0262] FIG. 58 shows a flowchart explaining a balloon expansion procedure using a handheld insertion instrument according to Embodiments 1 to 8, 11, 15, and any combination thereof. Depending on the embodiment, this method includes aligning the guide tube with the anatomical passage by bending or rotating at least a part of the guide tube. Grasp the insertion instrument with one hand, insert the guide tube portion of the handheld insertion instrument into the patient's nostril, and using an endoscope, penetrate deeper until correctly positioned at the opening of the anatomical passage to be expanded.

[0263] Preferably, one operator handles both the endoscope and the handheld insertion instrument. Depending on the embodiment, the operator can also guide a guide wire through the lumen within the balloon catheter and into the anatomical passage from the distal end of the guide tube to confirm the position.

[0264] Thereafter, the operator applies a first force f1 to a movable member of the handheld insertion instrument, i.e., a thruster or a handle, to advance the balloon catheter such that the balloon portion extends from the catheter guide tube and penetrates into the anatomical passage. Subsequently, the operator applies a second force f2 (which is greater than the first force f1) to the same movable member of the handheld insertion instrument to inflate the inflatable portion of the balloon catheter. Thereafter, the operator applies an even greater third force f3 to the same movable member of the handheld insertion instrument to pressurize the balloon catheter. In this state, the insertion instrument automatically locks the movable member relative to the instrument body so that the required pressure can be maintained without the operator applying an external force. After the pressurized balloon has been applied to the anatomical passage, in some embodiments, the operator may release the interlock between the movable member (plunger rod / handle) and the instrument body. This may be done, for example, by applying a new pressure to the thruster / handle for pressure release after the expansion is complete. Then the operator stops applying force to the thruster or the movable member and withdraws the deflated balloon. In the flowchart diagram, the dashed box indicates an optional (non-essential) step in the balloon expansion procedure.

[0265] FIG. 59 is a perspective view of a hand-held insertion instrument according to the twelfth embodiment having two (separate) thrusters / handles 307 and 308. Instrument body 302 includes a longitudinally extending groove 313 and a pair of guide plates 310 sandwiching groove 313. Groove 313 and guide plates 310 provide a track for guiding an elongated cylindrical object such as an insertion tube, a flexible endoscope, or a rigid endoscope along the longitudinal direction of hand-held insertion instrument 300. Similar to FIGS. 54a-54c, a syringe barrel is provided within instrument body 302, into which a plunger rod and a seal element are inserted. The proximal end of catheter guide tube 304 is connected to the distal end of instrument body 302. Distal thruster 307 is connected to the syringe barrel to linearly move the syringe assembly and balloon catheter 20 from a first position (retracted position) to a second position (extended position). Proximal thruster 308 is connected to the plunger rod to push the plunger rod into the syringe barrel only when the syringe assembly is in the second position (insertion / extended position). By having separate thrusters / handles 307, 308, the sense of control may be improved for two different procedural steps.

[0266] FIG. 60A is a perspective view of a first embodiment of a hand-held pressurizing instrument 400 for connecting to a separate balloon catheter and a luer lock connection that can be operated with a separate balloon catheter insertion instrument. Hand-held pressurizing instrument 400 has an instrument body 402 that also forms syringe barrel 414. Two rings 406 are also part of instrument body 402 and are provided to engage the operator's fingers. Plunger rod 412 is inserted into syringe barrel 414. The proximal end of plunger rod 414 is connected to thruster rod 413. A ring 408 for placing the operator's thumb is provided at the proximal end of thruster rod 413. In FIG. 60A, plunger rod 412 is fully inserted into syringe barrel 414. That is, the fluid chamber within the syringe barrel has a minimum volume, and it is the configuration of pressurizing instrument 400 when it is ready to aspirate liquid (water) into the balloon catheter via luer lock connection 418.

[0267] FIG. 60B is a cross-sectional view of a handheld pressurizing device 400 similar to that of FIG. 60A, and is a cross-sectional view in a first configuration in which the plunger rod 412 is fully inserted into the syringe barrel 414 and the liquid is ready to be filled by the retraction of the plunger. A first annular groove is provided at the proximal end of the thruster rod 413 and is aligned with a lock projection on the flexible proximal portion of the syringe body 402. The finger ring 406 on the syringe body can be moved radially outward by the operator to release the lock by the first annular groove and the lock projection. Thereby enabling the retraction of the thruster rod 413. The helical spring 415 transmits an axial force between the thruster rod 413 and the plunger rod 412. The plunger rod 414 is slidably received within the bore of the thruster rod 413 to allow for axial displacement of the plunger rod 412 relative to the thruster rod 413. A helical spring 415 is disposed between the thruster rod 413 and the plunger rod 412. An axial relief tube 417 that is in fluid communication with the chamber within the syringe barrel 414 is provided within the plunger rod 412. The relief tube 417 has a proximal radial portion that opens to the radially outer surface of the plunger rod 412. The function of the relief tube 417 will be described below.

[0268] FIG. 60C is a cross-sectional view of the handheld pressurizing device 400 in a secondary configuration. Here, the plunger rod 412 is inserted into the syringe barrel 414 but is in the retracted (proximal) position. In this state, the fluid chamber within the syringe barrel 414 is at its maximum volume after liquid suction and is filled with liquid. And the handheld pressurizing device 400 is in a state where it can be connected to the proximal end of a balloon catheter via a luer lock. A second circumferential groove is provided on the distal side of the thruster rod 413, which is adapted to align with the lock edge projection of the syringe body 402. Thereby providing a tactile sensation of the correct position and introducing an axial resistance before starting the balloon of the balloon catheter.

[0269] FIG. 61 is a cross-sectional view of a handheld pressurizing device 400 in a tertiary configuration. Here, the thruster rod 413 is locked to the syringe body 402, and the pressure in the syringe barrel exceeds the pressure set value. At this time, the plunger rod 412 moves proximally within the bore in the thruster rod 413 until the most proximal radial seal 419 (O-ring) on the plunger rod 412 reaches the axial position where it passes through the radial port 423 in the thruster rod 413, whereby an open fluid communication via the bleed tube 417 is formed between the chamber in the syringe barrel 414 and the surroundings. The helical spring 415 is compressed until such a state is reached. For this reason, water is discharged until the plunger rod 412 moves distally and the most proximal radial seal element 419 is no longer positioned proximally of the radial port 423 of the thruster rod 413. This configuration forms a pressure relief valve with relatively few parts. The water is exhausted into the cavity between the thruster rod 413 and the thruster guide portion of the syringe body 402. The distal seal element (O-ring) 424 prevents liquid (water) from flowing distally out of the clearance between the thruster rod 413 and the plunger rod 412. The exact amount of water required to fill a balloon catheter and any extension tubing that may be required is often not known. In the present embodiment, the syringe chamber is intentionally overfilled compared to the amount of water expected to be required for the balloon catheter and the extension tubing. Generally, the pressure relief function is always used, and varying amounts of water are released into the cavity of the device.

[0270] Figures 62, 63A - B, and 64A - C illustrate a second embodiment of the handheld pressurizing instrument 500. Figure 62 shows a perspective view of the handheld pressurizing instrument 500 according to the second embodiment, having an instrument body 502 with two thruster / finger hook plates 506 integrated, a distal - end luer lock for connecting to a balloon catheter, and a thruster rod 513 with a thruster / finger ring 508 at the proximal end of the thruster rod 513. Figure 63A shows the second embodiment of the handheld pressurizing instrument 500 in a filled configuration where the chamber in the syringe barrel 514 is pre - filled with water. The plunger rod 512 is slidably received within the axial bore of the thruster rod 513, similar to the first embodiment of the handheld pressurizing instrument, and a helical spring 515 transmits an axial force between the thruster rod 513 and the plunger rod 512. A lock mechanism 530 is shown and will be described in detail later. An axial relief tube 517 that provides fluid communication with the chamber in the syringe barrel 514 is provided within the plunger rod 512. The relief tube 517 has a proximal - side radial portion that opens to the radial outer surface of the plunger rod 512. The function of the relief tube 517 will also be described later.

[0271] Figure 63B shows the configuration of the handheld pressurizing instrument 500 during the inflation of the balloon catheter. (The connection portion of the balloon catheter is not depicted.)

[0272] Figures 64A - C are detailed cross - sectional views of the lock mechanism 530 and the relief valve of the handheld pressurizing instrument 500. The lock mechanism 530 has the same structure and operation as the second lock mechanism 230 of the embodiment of FIGS. 53 - 57.

[0273] The locking mechanism 530 has a first cylindrical cam body 531 that moves integrally with the thruster rod 513. The first cylindrical cam body 231 is preferably integrated with the thruster rod 513. The first cylindrical cam body 531 interacts with a second cylindrical cam body 532. The second cylindrical cam body 532 has a common axis with the first cylindrical cam body 531 and is rotatable about the common axis. The second cylindrical cam body 532 engages with a helical spring 515. The first cylindrical cam body 531 includes a plurality of cam surfaces that interact with a plurality of cam surfaces of the second cylindrical cam body 532, and imparts a unidirectional rotational movement to the second cylindrical cam body 532. Preferably, at least two or more inner axially extending ribs 533 project into a bore within the instrument body 502 that receives the first and second cylindrical cam bodies 531, 532 and interact with corresponding axially extending grooves within the first and second cam bodies 531, 532 to prevent rotation of the second cylindrical cam body 532 for most of the axial position (such as the position shown in FIG. 64A) of the second cylindrical cam body 532. However, when the second cylindrical cam body 532 is in the fully inserted position, i.e., the most distal position (such as the position shown in FIG. 64B), its rotation is not prevented. At the most distal position, the inner rib 533 disappears and the second cylindrical cam body 532 becomes rotatable. Then the second cylindrical cam body 532 comes into contact with the distal end of the rib 533, and as shown in FIG. 64C, the second cylindrical cam body 532 cannot move in the proximal direction. Thereby, the pressure on the helical spring 515, and thus on the plunger rod 512, is maintained.

[0274] In the plunger rod 512 of FIG. 64A, the external balloon catheter may already be fully filled and may be fully or partially pressurized. However, the locking mechanism has not yet been activated. In FIG. 64B, even when the balloon is fully expanded, the operator is still pushing the thruster rod 513 forward. As a result, the helical spring 515 is compressed, the force acting on the plunger rod 512 increases, and the hydraulic pressure in the chamber within the syringe barrel 514 and the balloon catheter rises. When the thruster rod 513 advances relative to the plunger rod 512, the hydraulic pressure increases. When the hydraulic pressure is less than the set value (e.g., 10 bar), the radial channel 519 in the thruster rod 513 is located proximal to the proximal O-ring 523 on the plunger rod 512. When the pressure exceeds the set value, the radial channel 519 of the thruster rod 513 is located distal to the proximal O-ring 523 of the plunger rod 512, and the pressure relief system opens. When the pressure relief system opens, water is discharged, so that the plunger rod 512 can advance relative to the syringe barrel 514. Finally, the second cylindrical cam body 532 reaches an axial position that is rotatable and axially locked against the internal axial locking rib 533 within the instrument body 502 of the lock housing. In FIG. 64C, the second cylindrical cam body 532 is rotated and locked. In this embodiment, the syringe chamber is intentionally overfilled compared to the amount of water expected to be required for the balloon catheter and the extension tube. Generally, the pressure relief function is always used, and some amount of water is released into the cavity of the instrument.

[0275] Figures 65-66 show a 13th embodiment of a hand-held balloon catheter insertion instrument 600. This hand-held insertion instrument has an instrument body 602, to which the proximal end of a balloon guide tube 604 is connected. A first trigger 608 for advancing the balloon catheter 20 is connected to the balloon catheter 20. The distal inflatable portion of the balloon catheter 20 is shown protruding from the tip of the balloon guide tube 604 in FIG. 65C. When the trigger 608 is in the retracted position (proximal position), the entire balloon catheter 20 is housed within the hand-held insertion instrument. A tube 650 is provided for connection to a separate balloon catheter pressurizing instrument. That is, in this embodiment, an integrated pressurizing instrument is not shown, but it is also possible to use an internal pressurizing instrument.

[0276] The balloon guide tube 604 has a straight proximal rigid portion and a distal flexible portion 605. The distal flexible portion 605 is normally straight when not forced into a non-straight shape. The flexible portion 605 of the balloon guide tube has two lumens 641, 642 (FIG. 66A). The first lumen 641 is for the balloon catheter, and the second lumen 642 is for the elastic control mandrel 640. The proximal end of the elastic control mandrel 640 is coupled to a second trigger 644 disposed in the instrument body 602 and is operable by the second trigger 644. In one variant of the 13th embodiment shown in FIG. 65D, the distal end 645 of the elastic control mandrel 640 is pre-bent into a semi-circular shape having a certain radius. In another variant of the 13th embodiment shown in FIG. 65E, the distal end of the elastic control mandrel 640 is pre-bent at a certain angle.

[0277] When the elastic control mandrel 640 is fully retracted into the proximal rigid straight portion of the guide tube 604, the distal flexible portion 605 of the guide tube 604 becomes straight. However, it is flexible and pliable. It is easy and painless to insert the guide tube 604 having the flexible and pliable distal guide portion 605 into the patient's nose.

[0278] In the first type of the 13th embodiment (Figs. 65A - D and 66A - E), the elastic control mandrel 640 is pre - bent, for example, into a semi - circular shape with a radius of 10 mm and a maximum of 180 degrees. In this first type, the forward movement of the elastic control mandrel 640 over a length L1 results in a first angle A1 of the flexible tip 605. Further forward movement of the elastic control mandrel 640 by the operator pressing the second trigger 644 over a length L2 results in a larger angle A2. When the elastic control mandrel 640 is fully retracted, the angle of the flexible tip 605 is 0 degrees. In the state where the elastic control mandrel 640 is fully advanced, as seen in Fig. 66E, the flexible tip 605 may be bent 180 degrees. Alternatively, when the elastic control mandrel is fully advanced, the fully bent angle of the flexible tip 605 may be only 90 degrees, or another angle between 20 - 180 degrees. Thus, the operator can control the angle of the distal end of the balloon guide tube 604 by axially displacing the elastic control mandrel 640 within the second lumen 642 relative to the guide tube 604, for example, between 0 - 180 degrees. The elastic control mandrel 640 is preferably made of stainless steel having high elasticity and resilience. Thereby, its distal portion 645 can bend the flexible distal portion 605. Also, in the straight rigid portion of the guide tube 604, it is quite easy to straighten it without applying excessive force in the straight portion of the second lumen 642. The rigidity of the elastic control mandrel 640, especially the rigidity of the curved distal portion 645, is balanced to overcome the rigidity of the flexible distal portion 605. Also, it needs to be slidable easily within the straight and rigid portion of the longitudinal range of the second lumen 642. A lubricant may be applied to the clearance between the elastic control mandrel 640 and the second lumen 642. Low - friction surfaces / materials can be used for the surfaces of the elastic control mandrel 640 and the second lumen 642.

[0279] In the second type (FIG. 65E) of the 13th embodiment, the required angle is known, and the elastic control mandrel 640 may be pre-bent at the angle by either the manufacturer or the operator. In this second configuration, the elastic control mandrel 640 can be switched between a first position where the elastic control mandrel 640 is fully retracted inside the rigid portion of the guide tube 604 and the distal end 605 of the guide tube is straight, and a second position where the elastic control mandrel 640 fully advances into the second lumen 642 and the flexible distal end 605 of the guide tube follows the angle and shape of the elastic control mandrel 640.

[0280] The operator may deform the elastic control mandrel 640 into any shape or angle when the elastic control mandrel 640 is fully advanced by plastically deforming the material of the elastic control mandrel 640. To facilitate insertion into the patient's nose, this custom shape or angle can be retracted into the rigid portion of the guide tube 604. When the distal portion 605 of the guide tube passes through the narrow region of the nose and reaches the wide portion of the nose, the operator may advance the pre-formed elastic control mandrel 640, and due to the properties of the elastic control mandrel 640 material, the custom shape reappears.

[0281] The elastic control mandrel 640 is rotated about its axis, thereby changing the plane of the angled distal portion 645 of the elastic control mandrel 640, thereby changing the direction of the angled tip 605 of the flexible portion of the guide tube 604. By the translational movement of the second trigger 644, and thus the translational movement of the elastic control mandrel 640, the operator can adjust the bending angle of the distal end 605 of the guide tube 604. By the rotational movement of the second trigger 644, and thus the rotational movement of the elastic control mandrel 640, the operator can adjust the bending direction of the distal end 605 of the guide tube 604 to any position above, below, left, right, or in between. By simply placing one finger on the trigger, the user can arbitrarily adjust the direction and tip angle of the distal end 605 of the guide tube 604.

[0282] The flexible portion 605 of the guide tube 604 is preferably made of a thermoplastic polymer material for extrusion and tip forming by melting. The double lumen extrusion tube may preferably be post-processed at the tip portion 605 by applying heat and a tip mold. This post-processing includes sealing the flexible core lumen and forming a rounded thin tip portion. The rigid portion of the guide tube 604 can be a steel tube disposed around the flexible extrusion tube. The extrusion tube has a length from the distal end 605 into the instrument body 602 and receives the balloon catheter 20 and the elastic control mandrel respectively.

[0283] In another embodiment applicable to all hand-held insertion instruments described herein, an additional (second or third) lumen within the extruded tube is included to provide a suction port. The additional lumen within the extruded tube can alternatively function as an irrigation port. In total, the extrusion profile may include four lumens selected from the balloon catheter guide tube lumen, the elastic control mandrel lumen, the suction port lumen, and the irrigation port lumen.

[0284] Figures 67A - E show a fourteenth embodiment of a hand - held balloon catheter insertion instrument 700. The hand - held insertion instrument has an instrument body 702 and a balloon guide tube 704 extending from the instrument body 702. A first trigger 708 for advancing the balloon catheter 20 is connected to the balloon catheter 20. The distal inflatable portion of the balloon catheter 20 is shown protruding from the tip of the balloon guide tube 704 in FIG. 67D. When the trigger 708 is in the retracted position (proximal position), the entire balloon catheter 20 is housed within the hand - held insertion instrument 700. A flexible tube 750 is provided for connection to a separate balloon catheter pressurizing instrument. That is, in this embodiment, an integrated pressurizing instrument is not shown, but it is also possible to use an internal pressurizing instrument.

[0285] The balloon guide tube 704 has a straight rigid outer tube 706 on the proximal side and an inner tube 705 disposed concentrically within the outer tube 706. The inner tube 705 has a distal portion that is pre - formed or pre - bent into a shape that substantially corresponds to a semi - circle having a predetermined radius. A lumen for the balloon catheter 20 is provided longitudinally within the inner tube 705. The proximal end of the inner tube 705 is coupled to the instrument body 702 so as to allow rotation about its longitudinal axis with respect to the instrument body 702, but not translational movement with respect to the instrument body 702. This rotation is imparted by the operator rotating a disk 709 that is coupled to the inner tube 705 and protrudes at least partially from the instrument body 702. The outer tube 706 is configured to be axially relatively movable with respect to the instrument body 702, and thus with respect to the inner tube 705, and the axial movement of the outer tube 706 is imparted by a trigger / handle 707 that can be engaged by the operator's finger or hand. Thus, the inner tube 705 and the outer tube 706 are configured to rotate and translate relative to each other. When the outer tube 706 is fully advanced, the guide tube 704 becomes completely straight, facilitating insertion into the patient's nose. When the outer tube 706 is fully or partially retracted, the pre - bent distal portion of the inner tube 705 is exposed, obtaining a desired angle.

[0286] Figures 68A-C show one kind of the 14th embodiment, and are essentially the same as the 13th embodiment except that there is only one thruster / handle 807 used by the operator to move the outer tube 806 of the balloon catheter guide tube 804 back and forth and rotate the inner tube 805. The balloon catheter 20 can include a proximal axial connection port for an illumination guide wire and a radial connection port for connection with a pressurizing device. The instrument body 802 can include an L-shaped slit having an axial section and a circumferential section to guide one thruster / handle 807 in one or more specific rotation planes. Alternatively, the opening of the instrument body 802 can also allow the thruster / handle 807 to rotate and translate freely. A sleeve 810 is provided to guide the axial displacement and rotational movement of the outer tube 806 relative to the inner tube 805 and the instrument body 802. In this embodiment, the balloon catheter 20 may have a handle / thruster-like element 808 for advancing and retracting the balloon catheter.

[0287] Figures 69A-69J show a first embodiment of a handheld balloon catheter insertion instrument 900 with a controllable and deformable guide tube tip 904.

[0288] Figure 69A shows the insertion instrument 900 in a first state before being inserted into a human nostril. The insertion instrument 900 has an instrument body 902 and a guide tube 904 having a distal deformable portion 906 and a proximal portion 905. The distal deformable portion is likely to return to a straight state due to its elasticity and is preferably capable of bending only within a specific plane. A rotatable knob 931 is arranged to rotate the guide tube 904 relative to the instrument body 902. An instrument body gripping portion 906 is provided so that the operator's finger can be placed thereon.

[0289] A first drive member 909 is provided to advance the guide tube 904 distally relative to the instrument body 902 to bend the bendable distal portion 906. The first drive member 909 is shown in a first position where the bendable portion 906 of the guide tube remains straight. A second drive member 910 is provided to slide linearly relative to the instrument body 902 within the guide track 911. When the second drive member 910 is slid in this way, the guide wire 917 advances from the tip of the guide tube 904. The second drive member 910 is shown in a first position where the guide wire 917 is retracted. A third drive member 907 is provided to advance the syringe assembly 914 relative to the instrument body 902 to advance the balloon catheter 920 from the distal end of the guide tube 904. The third drive member 907 is shown in a first position where the balloon catheter 920 is fully housed within the guide tube 904. A fourth drive member 908 is provided to advance the proximal end of the syringe assembly 912 relative to the distal end of the syringe assembly 913 to move the inner plunger 915 within the inner syringe barrel 916 having a certain amount of water 918 for inflation and pressurization of the balloon catheter 920. The fourth drive member 908 is shown in a first position where the inner plunger 915 is fully retracted relative to the inner syringe barrel 916.

[0290] FIG. 69B shows the insertion instrument 900 in a second possible state after insertion of the guide tube 904 into the human nostril. In this state, the first drive member 909 is in the second position and the distal deformable portion of the guide tube 906 is bent.

[0291] FIG. 69C shows the insertion instrument 900 in a third state. In this state, the second drive member 910 is also in the second position and the guide wire 917 extends from the tip of the guide tube 904.

[0292] FIG. 69D shows the insertion instrument 900 in the fourth state. In this state, the third drive member 907 is also in the second position, and the balloon catheter 920 is advancing beyond the guide wire 917 from the tip of the guide tube 904.

[0293] FIG. 69E shows the insertion instrument 900 in the fifth state. In this state, the fourth drive member 908 is also in the second position, and the balloon catheter 920 is inflated.

[0294] FIG. 69F is a partial cross-sectional view of the insertion instrument 900 in the first state. The syringe assembly 914 has a proximal portion 913 coupled to an internal plunger 915 and a distal portion 912 having a syringe barrel 916 with an internal water storage portion 918. The syringe barrel is directly coupled to the balloon catheter 920, and the water storage portion 918 is in fluid communication with the inflatable portion of the balloon catheter 920. An internal locking mechanism 924 is provided to lock the proximal portion 913 of the syringe assembly to the distal portion 912 of the syringe assembly. This locking mechanism is substantially the same as that of FIG. 64, and an internal pressure relief valve 925 configured to avoid overinflation of the balloon catheter is provided within the proximal portion 913 of the syringe assembly. The relief valve 925 is substantially the same as that of FIG. 64.

[0295] FIG. 69G shows the tip of the bendable portion 906 of the guide tube having one lumen 926 for guiding the balloon catheter 920 and another lumen 927 for the pull wire 921.

[0296] FIG. 69H is a detailed cross-sectional view of the insertion instrument 900. The proximal hub 922 is coupled to the guide tube 906 and is configured to move linearly within the instrument body 902. The pull wire 921 has one end attached to the instrument body 902 and the other end attached to the distal end of the guide tube 906 or in the vicinity thereof to fix the pull wire 921. The balloon catheter 920 is inserted into the proximal end of the guide tube 906.

[0297] FIG. 69I is a partial cross-sectional perspective view of the insertion instrument 900 in the first state. To facilitate viewing of the internal components, half of the instrument body 902 is not shown. The proximal hub 922 is shown in cross-section. The rotatable knob 931 is shown in partial cross-section. The first drive member 909 is in the first position. The first drive member is coupled to push the proximal hub 922 distally. The proximal hub 922 is guided within the insertion instrument 902 for linear movement and is partially inserted into the rotatable knob 931. The knob 931 has a key and keyway interface that allows for linear axial movement and transmits rotational force. The spring 917 between the proximal hub 922 and the rotatable knob 931 is shown at its first length where it is not compressed. The balloon catheter 920 is inserted at the proximal end of the deformable portion 906 of the balloon catheter. The deformable portion 90 is inserted at the proximal end of the rigid portion 905 of the guide tube. The deformable portion 906 of the guide tube may be able to rotate and translate freely within the rigid portion 905 of the guide tube. The pull wire 921 is fixed to the instrument body 902 and is inserted into the pull wire lumen 927.

[0298] FIG. 69J shows the insertion instrument 900 in the second state with the first drive member 909 in the second position, from the same perspective as FIG. 69I. The proximal hub 922 and the deformable portion 906 of the guide tube have moved distally relative to the instrument body 902 and relative to the pull wire 921, such that the deformable portion 906 of the guide tube is fully bent. The spring 917 is presented at its second compressed length. The serrated surface (not visible) on the rod of the first drive member 909 engages the serrated cam (not visible) of the instrument body 902 and functions as a releasable one-way lock to hold and lock any position of the drive member 909 between the first and second positions. This mechanism allows for locking at any degree of bend.

[0299] Figures 70A-70B show a 15th embodiment of a handheld balloon catheter insertion instrument 1014. In this embodiment, a linear track 1005 for supporting a part of the shaft of the endoscope 1064 is provided at the upper part of the distal portion of the instrument body 1002. The insertion instrument 1014 has a non-straight instrument body 1002 on the proximal side. The instrument body 1002 has a first drive member 1009 for advancing a guide wire and a second drive member 1008 for advancing a balloon catheter. The bent-shaped instrument body 1002 provides a space for the large hub 1065 on the proximal side of the rigid digital endoscope 1064. For this reason, there is an angle between a first central axis X defined by a linear track for supporting the endoscope 1064 and a second central axis Y defined by the longitudinally elongated portion on the proximal side of the instrument body 1002. Preferably, the longitudinally elongated portion on the proximal side of the instrument body is away from the central axis of the endoscope shaft when supported by a linear track to provide a space for the larger proximal end of the rigid endoscope. The angle α is preferably 5-90 degrees, more preferably 10-60 degrees, and most preferably 20-45 degrees.

[0300] The drive members are arranged on the lower side of the instrument body 1002 so as not to collide with any part of the endoscope shaft 1064 or the endoscope hub 1065. The second drive member is arranged in a linear guide track. The first drive member is also arranged in the same linear guide track. The second drive member is provided with a vertical connection port for connecting to an external pressurizing instrument.

[0301] Figure 71 shows a 16th embodiment of a hand-held balloon catheter insertion instrument 1114. Also in this embodiment, a linear track 1105 for supporting a part of the shaft of the endoscope 1164 is provided at the upper part of the distal portion of the instrument body 1102. The insertion instrument 1114 has a proximal, bent instrument body 1102 that includes a linear guide track 1103 for guiding the syringe assembly 1110 toward the guide tube 1104. The angle between the proximal portion of the instrument body and the linear track for supporting the shaft of the endoscope 1164 is the same as in the embodiment of FIGS. 70A-B. The syringe barrel 1101 of the syringe assembly has a rail 1107 that fits inside the linear guide track 1103 for guiding linear movement with respect to the instrument body 1102. The gripping portion 1006 is preferably provided for gripping by the middle finger of the operator. In this way, the operator can place the index finger on the endoscope shaft and push it down with respect to the linear track 1105. The syringe barrel 1101 is connected to the balloon catheter 1120 such that the water-containing space in the syringe barrel 1101 is in fluid communication with the inflatable portion of the balloon catheter 1120. A drive member 1108 is provided on the syringe barrel 1101 for advancing the balloon catheter 1120 distally and out of the distal end of the guide tube 1104 when moving the syringe assembly 1110 toward the guide tube 1104. After the balloon catheter 1120 has been extended out of the distal end of the guide tube 1104, a plunger rod 1112 having a proximal thumb interface 1109 can be pushed into the syringe barrel 1101 to inflate the balloon catheter 1120. The bent-shaped instrument body 1102 provides space for the large hub at the proximal portion of a rigid analog endoscope. The drive member assembly is disposed below the instrument body so as not to collide with any part of the endoscope.

[0302] Figures 72A-72F show a seventeenth embodiment of a hand-held balloon catheter insertion device. This embodiment includes a balloon catheter 1220, a guide tube 1204, an instrument body 1202 coupled to the proximal end of the guide tube 1204, and a cylindrical valve member 1243. The instrument body 1202 has a cylindrical internal cavity and a side port 1250 for fluid connection to an external pressurizing device. The cylindrical valve member 1243 is fluidly and connected to the proximal end of the balloon catheter 1220. Also, it has three seal rings 1252, 1254, 1255 spaced axially to seal against the inner surface of the cylindrical cavity of the instrument body 1202. Any external pressurizing device can be connected to the side port 1250 directly or via an extension tube. The depicted pressurizing device 1259 may be pre-loaded and locked as part of the preparation. The valve member 1243 is connected to a thruster rod 1242 so as to move integrally therewith and can be pushed distally to advance the balloon catheter 1220 as seen in Figure 72B. The thruster rod is sealed to the instrument body by a thruster rod seal 1251. In the state of the valve member 1243 shown in Figure 72D, the balloon catheter 1220 has advanced almost completely and the side port 1250 is located between the seal ring 1254 and the seal ring 1255. Nothing is connected to the internal channel 1249 of the valve member. Only when the valve member 1243 is in the fully advanced position, as shown in Figure 72E, a fluid connection is established between the side port 1250 and the lumen of the balloon catheter 1220 through the channel 1249 of the valve member 1243. When the pressurizing device supplies fluid (usually water) at this time, the balloon expands as shown in Figure 72C. The channel 1249 extends axially through the valve member 1243 from the distal end of the valve member 1243. It also has a radially extending portion that opens to the circumferential surface of the valve member 1243 between the radially spaced seal rings 1252 and 1254. When the valve member 1243 is in the fully advanced position, the side port 1250 is located between the axially spaced radially seal rings 1252 and 1254 and establishes a fluid connection with the channel 1249.That is, fluid can flow from side port 1250 to channel 1249. This configuration can prevent the balloon within guide tube 1204 from expanding earlier than intended. When the valve member is in the forward position, a sub-atmospheric pressure (partial vacuum) is created within chamber 1245 proximal to valve member 1243, which acts as a return spring for valve member 1243. Optional distal spring 1248 can provide a tactile resistance before valve member 1243 reaches the open valve position, so that the operator can accurately grasp when the connection between the pressurizing device and the balloon catheter will open. Helical spring 1248 may be provided according to an embodiment and is disposed between the distal end of valve member 1243 and the inner side of the distal surface of instrument body 1202. To move valve member 1243 against the bias of the return spring and helical spring 1248 to the open valve position of FIG. 72E, thruster rod 1242 needs to be pushed relatively strongly (by the operator's thumb pressing thumb plate 1204). Helical spring 1248 may be provided according to an embodiment and serves only to provide tactile feedback to the operator so that the operator can determine the timing to start inflation. To close the valve and sufficiently maintain the pressure within the balloon, the operator only needs to slightly relax the force applied to thumb plate 1204. When the force applied to thruster rod 1242 is completely released, a channel opens between chamber 1245, which is at a negative pressure, and the lumen of balloon catheter 1220, and the balloon contracts. When balloon catheter 1220 contracts, the remaining negative pressure may be configured to pull balloon catheter 1220 back into guide tube 1204. The distal end of plunger rod 1242 functions as a seat valve that closes the axially proximal port within valve member 1243 that communicates with channel 1249. This proximal port closes with only a small force applied distally to plunger rod 1242 and opens when the application of force to plunger rod 1242 is stopped.

[0303] Figures 73A - B show a cross - section of a locking mechanism that can be used in all embodiments of a handheld insertion instrument. This locking mechanism and method prevent premature inflation of the balloon before it has fully advanced from the guide tube. A plunger 1351 is slidably disposed within a syringe barrel 1322, defining a fluid - filled syringe chamber 1332. The syringe barrel 1322 is slidably and sealably received within a cylindrical cavity in the instrument body 1302. The distal end of the syringe barrel 1322 is provided with an enlarged - diameter section. The center of this enlarged section is offset from the centers of the other sections. The enlarged section is provided with three radially - spaced seals axially, illustrated as a first radial seal 1351, a second radial seal 1353, and a third radial seal 1355 respectively. These are seals to prevent leakage against the cylindrical inner surface of the instrument body 1302. The proximal end of the balloon catheter 1320 is mechanically and fluidly connected to the syringe barrel 1322 and moves with the syringe barrel 1322.

[0304] A first radial port 1362 is disposed at or near the distal end of the syringe chamber 1332. The first radial port 1362 is disposed between the first radial seal 1351 and the second radial seal 1353. The diameter - enlarged portion of the syringe barrel 1322 also includes a second radial port 1364. The second radial port 1364 is disposed between the second radial seal 1353 and the third radial seal 1355. The second radial port 1364 communicates with the lumen of the balloon catheter 1320.

[0305] On the cylindrical inner surface of the instrument body 1302, there is a recess 1366 that coincides with the second radial seal 1353 when the syringe barrel 1322 is fully advanced. As a result, the recess 1366 forms a bypass that spreads to both axial sides of the second radial seal 1353, as shown in FIG. 73B. Due to this bypass, when the syringe barrel 1322 is fully advanced, a hydraulic connection is formed between the syringe chamber 1332 and the lumen of the balloon catheter 1320 via the first radial port 1362 and the second radial port 1364. Thereby, when the plunger rod 1351 is pushed into the syringe chamber 1332, the fluid in the syringe chamber 1332 is pushed into the lumen of the balloon catheter 1322, inflating and pressurizing the balloon of the balloon catheter 1320.

[0306] When the syringe barrel 1322 has not yet been fully advanced, the discharge of fluid from the syringe chamber 1332 is blocked by the first and second radial seals 1351 and 1353 that seal against the cylindrical inner wall of the instrument body 1302. This prevents the plunger rod 1351 from being inserted into the syringe chamber 1332. Therefore, when the plunger rod 1351 is pushed, the syringe barrel 1322 moves with it. However, when the syringe barrel 1322 reaches the innermost position or when the bypass is established, by further pushing the plunger rod 1351, the liquid in the syringe chamber 1332 is discharged and the balloon is inflated and pressurized.

[0307] The space within the instrument body 1302 not occupied by the plunger rod 1351 and the syringe barrel 1322 is vented to the atmosphere (ambient) to prevent overpressure or underpressure in the instrument body cavities on both sides of the seal ring.

[0308] FIG. 74 shows a flowchart for explaining a balloon dilation procedure using a handheld insertion instrument according to Embodiments 1 to 8, 11, 15, and any combination thereof. Depending on the embodiment, as a first step, the operator may bend and rotate a portion of the guide tube to correspond to the anatomical passage to be dilated. Once ready, the operator can grasp the handheld insertion instrument with only one hand and insert the guide tube into the human nostril until it is correctly positioned in the passage to be dilated. Depending on the anatomical passage, it may be necessary to insert a guide wire into the passage to confirm the position. The guide wire may be an optional component of the insertion instrument, and advancing the guide wire into the passage may be an optional step of the procedure. When the position of the guide tube is confirmed by using an endoscope, the operator can use only one finger to push the movable member for advancing the balloon catheter from the proximal end of the guide tube into the passage from the first position to the second position without changing the grip of the insertion instrument. Thereafter, the operator can use the same finger of the same hand to further push the same movable member from the second position to the third position without changing the grip of the insertion instrument for balloon inflation and pressurization. When the movable member is moved to the third position, the movable member is automatically locked, and the hydrostatic pressure in the balloon catheter is stably maintained without applying an external force. After dilation of the passage, the operator can release the lock of the locked movable member to release the hydrostatic pressure in the balloon catheter. Thereafter, the operator can push the movable member in the reverse direction from the third position to the second position to contract the balloon, and further push the movable member from the second position to the first position to retract the balloon. Finally, the operator releases the movable member and withdraws the guide tube from the nostril.

[0309] In some cases, the operator may simply hold the movable member in the third position during the expansion of the passageway without locking and unlocking the movable member. In some cases, the operator may simply pull the guide tube out of the nostril as soon as the pressure of the balloon is released, and the contraction and retraction of the balloon may be omitted. In some cases, the pre-bent tip of the guide tube and the angle of the guide tube may be adapted to the surgery, and it may not be necessary to bend or rotate the guide tube.

[0310] FIG. 75 is a flowchart for explaining a balloon expansion procedure using a handheld insertion instrument according to a ninth embodiment. First, the operator places the endoscope shaft in a linear trajectory of the instrument body and grips the grip portion of the insertion instrument with one hand. At this time, the insertion instrument is gripped so that a part of the finger or a part of the hand presses down the endoscope shaft with respect to the linear trajectory and completely supports a part of the endoscope shaft. Then, the operator can insert the guide tube of the insertion instrument and the endoscope shaft into a person's nostril with only one hand. The operator may want to adjust the position of the endoscope in order to change the field of view or improve access to the nostril. For this purpose, the operator may loosen the pressure applied to the endoscope with a part of the finger or hand, and may translate, rotate, or slightly adjust the angle of the endoscope shaft with respect to the guide tube. Then, pressure is applied to the endoscope again to fix the adjusted position. When the guide tube is correctly positioned and a satisfactory field of view is obtained, the operator may push the drive member of the insertion instrument without changing the one-handed grip position in the insertion instrument, and advance the balloon catheter from the distal end of the guide tube into the passageway. When the balloon is completely inserted into the passageway, the balloon may be inflated using a pressurizing device such as a syringe assembly. The pressurizing device may be built into the insertion instrument or may be operated from the outside. After the passageway is expanded, the balloon may be contracted and the insertion instrument may be pulled out of the nose.

[0311] FIG. 76A is a flowchart illustrating the procedure for using a pressurizing device according to FIGS. 60A to 64C, or combinations or variations thereof. The pressurizing device may be pre-coupled to the balloon catheter and provided with water pre-filled in the syringe barrel of the device. Alternatively, as a first step, it may be necessary to couple the pressurizing device to the balloon catheter or to fill it with water. If it is necessary to couple the pressurizing device to the balloon catheter or to fill it with water, these will be the first steps. The operator immerses the distal fluid port of the syringe barrel in a water bath, pulls the thruster back from the fully inserted position to the fully retracted position, and aspirates water into the syringe barrel. It may be necessary to expel air bubbles from the syringe barrel, as is often the case when filling a syringe.

[0312] As a final preparation step, the operator connects the balloon catheter to the distal fluid port of the syringe assembly. When the pressurizing device is ready after the preparation steps, or if it is already prepared and connected, the next step is performed. The operator holds the pressurizing device with one hand, presses the thruster to the end stop position to inflate the balloon, and achieves the desired predetermined hydrostatic pressure required for the balloon. Thereafter, the operator may lock the thruster in the end stop position. In that case, the hydrostatic pressure within the balloon can be maintained without applying an external force. Thereafter, the lock of the thruster may be released. Finally, the operator may pull back the thruster to deflate the balloon.

[0313] FIG. 76B is a flowchart illustrating the procedure for using a pressurizing device according to FIGS. 60A to 64C, or combinations or variations thereof. The pressurizing device may be pre-coupled to a balloon catheter and provided with water pre-filled in the syringe barrel of the device. Alternatively, as a first step, it may be necessary to couple the pressurizing device to the balloon catheter or to fill it with water. When it is necessary to couple the pressurizing device to the balloon catheter or to fill it with water, these will be the first steps. The operator immerses the distal fluid port of the syringe barrel in a water tank, pulls back the thruster from the fully inserted position to the fully retracted position, and aspirates water into the syringe barrel. As is often the case when filling a syringe, it may be necessary to expel air bubbles from the syringe barrel.

[0314] As a final preparation step, the operator connects the balloon catheter to the distal fluid port of the syringe assembly. When the pressurizing device is ready after the preparation steps, or if it is already prepared and connected, the next step is performed. The operator holds the pressurizing device with one hand, pushes the thruster to the end stop position to inflate the balloon, and achieves the desired predetermined hydrostatic pressure required for the balloon. The thruster is automatically locked in the end stop position, and the hydrostatic pressure of the balloon is maintained without applying an external force. Thereafter, the operator can push the thruster again in the same direction to release the thruster lock. Finally, the operator may pull back the thruster to deflate the balloon.

[0315] FIG. 77 is a flowchart illustrating the procedure for using a balloon insertion device equipped with a deformable guide tube according to FIGS. 69A-69J or one of these.

[0316] As a first step, the operator may want to rotate the guide tube of the insertion device to determine the surface or direction for bending the flexible distal portion of the guide tube. This step can be omitted if the predetermined angle of the insertion device is acceptable.

[0317] The operator holds the insertion instrument with only one hand and inserts the straight guide tube into the person's nostril until the distal end of the guide tube is positioned near the passage to be expanded. Without changing the grip position of the hand holding the insertion instrument, the operator can use the thumb to push the first drive member and bend the distal end of the guide tube along the passage to be expanded. In some embodiments, the operator may further use the same thumb to push the second drive member distally and insert the guide wire into the passage without changing the grip position of the hand holding the insertion instrument. This step may not be necessary depending on the anatomical passage and may be omitted. Without changing the grip position of the hand holding the insertion instrument, the operator can use the thumb to push the third drive member distally and advance the inflation portion of the balloon catheter from the distal end of the guide tube into the passage. Without changing the grip position of the hand holding the insertion instrument, the operator can use the thumb to push the fourth drive member distally and inflate the balloon. The third drive member and the fourth drive member may be the same drive member pushed in two steps. Depending on the variation of this insertion instrument, there may be those without an integrated syringe assembly or those without a fourth drive member. In such cases, the step of pushing the fourth drive member is omitted and replaced by pressurizing the balloon using an external pressurizing device. Once the expansion is complete, the balloon is deflated and the insertion instrument is withdrawn. By the above procedure, the surgeon can operate the endoscope with a completely free hand, and the surgeon can perform the procedure without an assistant and with little discomfort to the patient.

[0318] It should be understood that any of the embodiments described herein may include various other features in addition to, or in place of, the features described above. It should also be understood that any one or more of the teachings, expressions, examples, embodiments, etc. described herein may be combined with any one or more of the other teachings, expressions, examples, embodiments, etc. described herein. Accordingly, the teachings, expressions, examples, embodiments, etc. described above should not be viewed in isolation from one another. Various suitable ways of combining the teachings of this specification will be readily apparent to those skilled in the art in light of the teachings of this specification. Such modifications and variations are also intended to be included within the scope of the claims.

[0319] The above versions can be designed to be discarded after a single use or to be used multiple times. In either case, or both, after at least one use, it may be readjusted for reuse. Readjustment may include any combination of the stages of disassembling the instrument, followed by cleaning or replacing specific parts, and then reassembling. In particular, some versions of the instrument can be disassembled, and any number of specific parts or components of the instrument can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some versions of the instrument may be reassembled for subsequent use in a readjustment facility or by the user immediately prior to the procedure. Those skilled in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly are available for readjusting the instrument. The use of such techniques and the resulting readjusted instrument are all within the scope of this application.

[0320] Merely illustrative, the versions described herein may be sterilized before and / or after surgery. In one sterilization technique, the instrument is placed in a sealed container such as a plastic or TYVEK bag. The container and instrument can then be placed in a radiation field that penetrates the container, such as gamma rays, X-rays, high-energy electron beams, etc. The radiation can kill bacteria within the instrument and container. The sterilized instrument is stored in a sterilized container for later use. Sterilization can also be achieved using other techniques known in the art. Non-exclusive examples of such techniques include beta rays, gamma rays, ethylene oxide, steam, etc.

[0321] Although various examples and embodiments have been shown and described, further adaptations of the methods and systems described herein will be achieved by appropriate modifications by those skilled in the art without departing from the scope of the invention. Some such potential modifications have been mentioned, but other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, shapes, materials, dimensions, ratios, steps, etc. described above are illustrative and not essential. Accordingly, the scope of the invention should be considered from the perspective of the following claims and is not to be limited to the details of the structures and operations shown and described in the specification and drawings.

[0322] The terms "comprising", "having", "including" as recited in the claims do not exclude the presence of elements or steps not recited. Even if it is not expressly stated that there are a plurality of elements recited in the claims, the presence of a plurality of such elements is not excluded.

[0323] The reference signs used in the claims shall not be construed as limiting the scope of the invention. Unless otherwise specified, the drawings are intended to be read together with the description and form part of the overall disclosure of the present application. In the description, terms such as "horizontal", "vertical", "left", "right", "up", "down", and their adjectival and adverbial forms (e.g., "horizontally", "rightward", "upward", etc.) merely represent the orientation of the structures illustrated in the direction in which the reader views them. Similarly, terms such as "inward direction" and "outward direction" generally represent the direction of a surface with respect to the longitudinal axis or the axis of rotation, depending on the situation. For the above-mentioned instrument, the term "distal" represents the direction towards the patient, and the term "proximal" represents the direction towards the operator of the instrument.

Claims

1. A handheld insertion instrument for balloon dilation of a human eustachian tube or other anatomical passage in the head, said instrument comprising: a balloon catheter; a syringe assembly having a plurality of components including a syringe barrel, a seal element, and a plunger rod; a balloon catheter guide tube for receiving and guiding said balloon catheter; an instrument body fixedly attached to the proximal end of said balloon catheter guide tube; and comprising: said balloon catheter having a distally expandable portion that will advance from the distal end of said balloon catheter guide tube, and a proximal portion that is fluidly connectable to said syringe assembly for inflation and pressurization of said balloon catheter; said instrument body having guiding means for the movement of one or more components of said syringe assembly towards said guide tube; said balloon catheter being coupled to one or more components of said syringe assembly for advancing said balloon catheter out of and beyond the distal end of said balloon catheter guide tube by the linear movement of said one or more components of said syringe assembly; an instrument.

2. The instrument according to claim 1, wherein said guiding means for the movement of said syringe assembly towards said guide tube is configured to guide said syringe assembly in a straight or slightly curved path towards said guide tube.

3. The instrument according to claim 1 or 2, wherein said guiding means for the movement of said syringe assembly is disposed at a connection between one or more inner surfaces of an open cavity of said instrument body and one or more outer surfaces or one or more portions of said syringe assembly.

4. The instrument according to any one of claims 1 to 3, wherein said guiding means for the linear movement of said syringe assembly relative to said guide tube is disposed between the outer surface of said syringe barrel and the inner surface of said instrument body.

5. The instrument according to any one of claims 1 to 4, configured to dilate a passage accessible from a human nostril, such as the eustachian tube or paranasal sinus passage.

6. The instrument according to any one of claims 1 to 5, wherein said syringe assembly is disposed within the cavity of said instrument body to move linearly, in part or in whole.

7. The instrument according to any one of claims 1 to 6, wherein the syringe assembly is arranged such that the distal end of the syringe barrel having a fluid connection port faces the balloon catheter guide tube, and the balloon catheter is in fluid communication with the distal end of the syringe barrel and is attached directly or indirectly to the syringe barrel, and is arranged with respect to the instrument body.

8. The instrument according to any one of claims 1 to 7, wherein the syringe assembly is arranged in the opposite direction with respect to the instrument body, the plunger rod is arranged facing the balloon catheter guide tube, the balloon catheter is in fluid communication with the syringe barrel through the lumen of the plunger rod, and the balloon catheter is attached directly or indirectly to the plunger rod.

9. The instrument according to any one of claims 1 to 8, wherein the syringe assembly is pre-filled with a liquid, and the liquid pre-filled here is preferably an exact amount of liquid required to fill and pressurize the balloon catheter to an appropriate pressure when the plunger rod and the seal element are arranged at an exact defined position with respect to the syringe barrel.

10. The instrument according to any one of claims 1 to 9, wherein the instrument body and the guide tube define a reusable instrument into which a disposable custom single-use syringe assembly and a balloon catheter can be inserted and operated.

11. The instrument according to any one of claims 1 to 10, wherein the instrument includes the instrument body, the guide tube, the balloon catheter, and the syringe assembly, is pre-assembled, and is configured as a disposable type that can be used only once.

12. A first configuration in which the syringe assembly and the balloon catheter are in a first position, the distal portion of the balloon catheter is not inflated, the plunger rod is retracted with respect to the syringe barrel, and is completely housed in the guide tube, and the syringe barrel is preferably filled with water, and The syringe assembly and the balloon catheter are in a second configuration where the distal portion of the balloon exits from the tip of the guide tube and advances, and the plunger rod is retracted relative to the syringe barrel; The plunger rod is inserted into the syringe barrel, and in a state where the balloon catheter is inflated, the syringe assembly and the balloon catheter are in the second position, a third configuration; The instrument according to any one of claims 1 to 11, having the above.

13. The instrument according to any one of claims 1 to 12, comprising an end stop that prevents further distal movement of the distal end of the syringe assembly when the syringe assembly and the balloon catheter are in the second position.

14. The distal end of the syringe assembly may be lockable at a number of positions relative to the instrument body such that the forward travel distance of the balloon from the distal end of the guide tube is variable and lockable, The locked position where the balloon is fully advanced coincides with the second position of the syringe assembly and the balloon catheter. The instrument according to any one of claims 1 to 13.

15. Having a first thruster and a second thruster, the first thruster being coupled to the distal portion of the syringe assembly and configured to move the syringe assembly and the balloon catheter from the first position to the second position, and the second thruster being coupled to the proximal portion of the syringe assembly and configured to move the plunger relative to the syringe barrel for inflation and pressurization of the balloon catheter. The instrument according to any one of claims 1 to 14.

16. Having only a single thruster coupled to the proximal end of the syringe assembly, the single thruster being configured to first move the syringe assembly and the balloon catheter from the first position to the second position, and then move the plunger relative to the syringe barrel for inflation and pressurization of the balloon catheter. The instrument according to any one of claims 1 to 15.

17. The instrument according to any one of claims 1 to 16, comprising a locking mechanism for preventing movement of the plunger relative to the syringe barrel when the syringe assembly and the balloon catheter are in the first position or between the first position and the second position.

18. The locking mechanism includes one or more resistance elements that create resistance between the plunger and the syringe barrel such that a second force F2 required to move the plunger relative to the syringe barrel is substantially greater than a first force F1 required to move the syringe assembly and the balloon catheter from the first position to the second position. The instrument according to any one of claims 1 to 17.

19. The one or more resistance elements according to claim 18 are one or more deformable elements on the plunger rod that protrude outward from the central axis of the plunger rod by a radius defined by the inner cylindrical surface of the syringe barrel.

20. The one or more resistance elements are the seal element, the seal element is an element that seals radially with respect to the syringe barrel, and a second frictional force F2 between the seal element and the syringe barrel is substantially greater than a first frictional force F1 between the syringe assembly and the balloon catheter with respect to the instrument body and the guide tube. The instrument according to claim 18 or 19.

21. The one or more resistance elements include one or more deformable elements disposed on either the plunger rod or the syringe barrel, preventing the plunger rod from moving into the syringe barrel, The second force F2 applied axially to a part of the syringe assembly is required to deform the deformable element radially to an extent that the plunger rod can be inserted into the syringe barrel. The instrument according to any one of claims 18 to 20.

22. The resistance element has a valve configured to control the passage of liquid between the liquid in the syringe barrel and the lumen of the balloon catheter, The valve is closed when the hydrostatic pressure of the liquid in the syringe barrel is below the pressure limit and opens when the hydrostatic pressure of the liquid in the syringe barrel exceeds the pressure limit. The second force F2 applied to a part of the syringe assembly is preferably required to reach the pressure limit, which is preferably higher than 2 bar, or, The resistance element includes a membrane configured to prevent the passage of liquid between the liquid in the syringe barrel and the lumen of the balloon catheter. The membrane ruptures when the hydrostatic pressure of the liquid in the syringe barrel exceeds the pressure limit that allows the passage of liquid between the liquid in the syringe barrel and the lumen of the balloon catheter. The instrument according to any one of claims 18 to 21.

23. The instrument according to any one of claims 18 to 22, wherein the one or more resistance elements include a flow restriction orifice between the fluid containing space in the syringe barrel and the balloon catheter.

24. The locking mechanism has a first locking mechanism. The first locking mechanism has a movable locking member, which preferably has a spherical form. The movable locking member has a locking position where the relative movement between the syringe barrel and the plunger rod is blocked, and an unlocking position where the relative movement between the syringe barrel and the plunger rod is possible. The instrument according to any one of claims 18 to 23.

25. In the locked position, the movable locking member is partially received in the recess of the plunger rod and partially received in the recess of the syringe barrel. In the unlocked position, the movable locking member is partially received in the recess of the syringe barrel and partially received in the recess of the instrument body. The recess of the instrument body is adapted to receive a part of the movable locking member when the syringe assembly and the balloon catheter are in the second position. The instrument according to any one of claims 18 to 24.

26. Means for preventing the balloon from expanding when the balloon is within the guide tube, the means preferably including a hydraulic lock that prevents the passage of liquid from the syringe barrel to the fluid connection port of the balloon catheter until the syringe assembly and the balloon catheter are in the second position. Three radial seal rings on the outer surface of the syringe barrel seal against the cylindrical cavity in the instrument body. A fluid port at the distal end of the syringe barrel penetrates the wall of the syringe barrel radially between the most proximal radial seal ring and the intermediate seal ring. Another fluid port disposed between the intermediate radial seal ring and the most distal radial seal ring is connected to the balloon catheter. One or more grooves on the inner surface of the cylindrical cavity allow fluid to pass from the syringe barrel through the intermediate radial seal ring to the balloon catheter only when the syringe assembly is in the second position with the expandable portion of the balloon catheter fully advanced out of the guide tube. The instrument according to any one of claims 1 to 25. **Claim 27** A third force F3 acting directly on a part of the syringe assembly or via a movable member or thruster of the instrument is required to pressurize the balloon catheter to a predetermined hydrostatic pressure necessary for successful expansion. The instrument according to any one of claims 18 to 26. **Claim 28** The first force F1, the second force F2, and the third force F3 act directly or indirectly via other members of the instrument from the same single finger or the same single hand engagement interface on one end of the syringe plunger assembly, thereby allowing the operator to advance the balloon, expand the balloon, and pressurize the balloon while keeping the instrument in the same hand or finger grip throughout. The instrument according to any one of claims 18 to 27. **Claim 29** The first force F1 is from 0 to 5 N, preferably the first force F1 is from 1 to 4 N, and more preferably the first force F1 is from 2 to 3 N. The instrument according to any one of claims 18 to 28. **Claim 30** The second force F2 is from 2 to 8 N, preferably the second force F2 is from 3 to 7 N, and more preferably the second force F2 is from 4 to 6 N. The instrument according to any one of claims 18 to 29. **Claim 31** The third force F3 is from 4 to 40 N, preferably the third force F3 is from 7 to 25 N, and more preferably the third force F3 is from 10 to 20 N. The instrument according to any one of claims 17 to 30. **Claim 32** The proximal end of the syringe assembly is lockable in one or more positions directly or through other lockable members of the instrument relative to the distal end of the syringe assembly, the instrument according to any one of claims 1 to 31.

33. The thruster connected to the proximal end of the syringe assembly is the lockable member lockable in one or more positions relative to the instrument body, the instrument according to any one of claims 1 to 32.

34. An elastic element is disposed between the lockable member of the instrument and the seal element that seals radially within the syringe barrel, and the elastic element preferably has one or more of a metal spring, a polymer spring, a gas spring, or a spring made of an elastic material, the instrument according to any one of claims 1 to 33.

35. All elastic elements disposed between the movable and lockable member of the instrument and the movable seal element within the syringe barrel portion of the instrument have a first state and a second compressed state, The third force F3 applied directly or indirectly to a part of the syringe assembly is necessary to compress the elastic element to the second compressed state, and the compressed spring, even when the external force is released, directly or indirectly applies the third force F3 to the movable seal element within the syringe barrel when the lockable member is locked. The instrument according to any one of claims 27 to 34.

36. The lockable member of the instrument is lockable in exactly one predetermined position, This position locks the syringe assembly when the balloon has advanced completely, the balloon has inflated completely, and is completely pressurized to a predetermined hydrostatic pressure, The lock member is locked when the elastic element is in the second compressed state. The instrument according to any one of claims 1 to 35.

37. Comprising a pressure relief valve in fluid communication with the fluid chamber of the syringe barrel, The pressure relief valve is adjusted to open when the hydrostatic pressure exceeds a predetermined hydrostatic pressure required for the dilation procedure. The instrument according to any one of claims 1 to 36.

38. The lumen passing through the plunger rod forms part of the fluid communication between the fluid within the syringe barrel and the pressure gauge, the instrument according to any one of claims 1 to 37.

39. The elastic element is disposed on the liquid side of the movable seal element within the syringe barrel and is connected such that the elastic element is compressed when the plunger rod moves within the syringe barrel. The elastic element is configured to push back the movable plunger rod when the force applied to the plunger rod is released. The instrument according to any one of claims 1 to 38.

40. An elastic element is connected between the instrument body and the syringe assembly, and when the syringe assembly is moved from the first position to the second position, the elastic element is either compressed or extended. The elastic element biases the syringe assembly to return from the second position to the first position when the applied external force is removed. The instrument according to any one of claims 1 to 39.

41. The instrument according to any one of claims 1 to 40, wherein a cylindrical cavity within the instrument body functions as the syringe barrel of the syringe assembly.

42. The instrument according to any one of claims 1 to 41, wherein the proximal end of the balloon catheter is directly connected to a movable seal element within the syringe barrel.

43. The movable seal element connected to the proximal end of the balloon catheter has a proximal radial seal ring and a distal radial seal ring. A fluid connection port between the two radial seal rings is in fluid communication with the lumen of the balloon catheter. One or more grooves are provided on the inner wall of the syringe barrel, and the grooves form a fluid passage straddling the proximal radial seal ring only when the proximal radial seal ring is axially aligned with the grooves. The instrument according to any one of claims 1 to 42.

44. The instrument body includes an endoscope support structure arranged in conjunction with a hand or finger grip portion of the instrument body for partially supporting a flexible or rigid endoscope, and the endoscope is fully supported only when one or more fingers or a part of the hand of the operator are firmly placed on the grip portion of the instrument body, whereby a part of the endoscope is pressed against the support structure. The instrument according to any one of claims 1 to 43.

45. The support structure can be configured as an open groove along at least a part of the outer surface of the instrument body, the open groove being parallel to the balloon catheter guide tube, the depth of the groove preferably being at least 1 mm, the width being at least 2 mm, and the length being at least 10 mm, the instrument according to claim 44.

46. The support structure is configured as one or more rows of holes or tubes arranged on the side surface of the instrument body, the holes or tubes preferably having an opening wider than 3 mm and higher than 3 mm, and the holes or tubes preferably having a central axis parallel to the guide tube, the instrument according to claim 44.

47. The support structure is configured as one or more forks arranged in a row on the side surface of the instrument body, the forks preferably having an opening wider than 3 mm and higher than 1 mm, and the forks preferably having a central axis parallel to the guide tube, the instrument according to claim 44.

48. The instrument body comprises an endoscope support structure including an elastic band or an elastic clip for fixing a part of the endoscope to the outer surface of the instrument body, the instrument according to any one of claims 1 to 47.

49. A method of balloon dilating an ear canal, a nasal sinus passage, or other anatomical passage in a human head accessible through a human nostril using a handheld insertion instrument, wherein the instrument is a balloon catheter, a syringe assembly having a proximal end, a balloon catheter guide tube for receiving and guiding the balloon catheter, and the balloon catheter has a distal inflatable portion that will project out of the distal end of the balloon catheter guide tube and a proximal portion fluidly connected to the syringe assembly for inflation and pressurization of the balloon catheter, and the method comprises a) grasping the instrument with one hand and inserting the guide tube into the patient's nostril and into the opening of the anatomical passage to be dilated until it is correctly positioned; b) pushing the distal portion of the balloon catheter out of the distal end of the guide tube and applying a first force F1 in the distal direction to the proximal end of the syringe assembly of the instrument with one finger of one hand to advance it into the anatomical passage to be dilated; c) Then, with the same single finger of the same hand, apply a second force F2 greater than the first force in the distal direction to the same proximal end of the syringe assembly of the instrument to inflate the inflatable portion of the balloon catheter; d) Subsequently, to pressurize the balloon catheter to expand the anatomical passageway, apply a third force F3 greater than the second force in the distal direction to the same proximal end of the syringe assembly of the instrument using the same single finger of the same hand; e) After completion of the expansion, release the force applied to the proximal end of the syringe assembly to release the pressure within the balloon catheter; f) Retract the deflated balloon; A method comprising the above steps.

50. g) After e) and before f), lock the proximal end of the syringe assembly relative to the distal end of the syringe assembly and hold the required hydrostatic pressure without applying an external force. The method according to claim 49.

51. g) After g) and before f), release the locked syringe assembly. The method according to claim 49.

52. The method according to any one of claims 49 to 51, comprising rotating or bending at least a part of the guide tube to direct the distal end of the guide tube towards the passageway to be expanded.

53. The method according to any one of claims 49 to 52, comprising advancing a guide wire into the anatomical passageway to confirm the placement.

54. The syringe assembly includes a plurality of components, and the plurality of components include a syringe barrel, a seal element, and a plunger rod. The method according to any one of claims 49 to 53.

55. The instrument includes an instrument body fixedly attached to the proximal end of the balloon catheter guide tube. The method according to any one of claims 49 to 54.

56. The instrument body has guiding means for the movement of one or more components of the syringe assembly towards the guide tube. The method according to claim 55.

57. The method according to any one of claims 49 to 55, wherein the balloon catheter is coupled to the one or more components of the syringe assembly to advance the balloon catheter out of the distal end of the balloon catheter guide tube by linear movement of the one or more components of the syringe assembly.

58. A method of balloon dilating an eustachian tube or other anatomical passageway in a human head accessible from the human nasal cavity using an instrument, wherein the instrument comprises a balloon catheter that may include a guide wire, a guide tube for receiving and guiding the balloon catheter, and a pressurizing device connected to a movable member, wherein the balloon catheter has a distally expandable portion that will extend out of the distal end of the balloon catheter guide tube and a proximal portion fluidly connected to the pressurizing device for inflation and pressurization of the balloon catheter, and the instrument further comprises a drive member coupled to the balloon catheter and configured to advance the distally expandable portion out of the distal end of the balloon catheter guide tube, the drive member also being coupled to the movable member, and the method a) in some embodiments, rotating or bending at least a portion of the guide tube to direct the distal end of the guide tube towards the passageway to be dilated; b) inserting the guide tube of the instrument into the nasal cavity and into the opening of the anatomical passageway to be dilated while holding the instrument with one hand until it is properly positioned; c) advancing a guide wire into the passageway to confirm placement; d) using a finger of one hand to push the movable member distally from a first position to a second position to advance the balloon out of the distal end of the guide tube and into the anatomical passageway to be dilated; e) using the same finger to further push the movable member forward from the second position to a third position for inflation and pressurization of the balloon catheter; f) in some embodiments, locking the movable member in a particular position or at a particular hydrostatic pressure relative to the instrument body to maintain the required hydrostatic pressure within the balloon catheter without applying an external force; g) in some embodiments, unlocking the same movable member. h) In some embodiments, to contract the balloon, pulling the same movable member rearward in the proximal direction from the third position to the second position; i) In some embodiments, to retract the balloon from the passage into the guide tube, pulling the same movable member rearward in the proximal direction from the second position to the first position; j) After expansion, pulling out the guide tube and the balloon catheter from the passage and the nostril; A method comprising the above.

59. A hand-held insertion instrument for balloon dilating the eustachian tube or other anatomical passage in a human head accessible from the human nose, comprising a balloon catheter, and a balloon catheter guide tube for receiving and guiding the balloon catheter, the balloon catheter having a distally expandable portion that will project out from the distal end of the balloon catheter guide tube, and a proximal portion fluidly connected to an internal or external pressurizing device for inflation and pressurization of the balloon catheter, the instrument further comprising a drive member coupled to the proximal end of the balloon catheter, and an instrument body fixedly connected to the proximal end of the guide tube, wherein at least a portion of the guide tube extending from the proximal end of the guide tube towards the distal end of the guide tube is straight, and the instrument body is shaped and sized such that it can be held and operated by an operator, the instrument body being provided with a linear track configured to support and guide a portion of the cylindrical shaft of a rigid or flexible endoscope, the linear track extending parallel to the straight portion of the guide tube, the linear track being configured to allow longitudinal displacement and rotation of the endoscope shaft relative to the instrument body, and to limit lateral movement of the cylindrical shaft relative to the instrument body in all directions except one direction. The instrument body and the linear track are configured such that a part of the hand of the operator holding the instrument can selectively apply pressure to the cylindrical shaft of the rigid endoscope or the flexible endoscope, pressing the cylindrical shaft of the rigid endoscope or the flexible endoscope against the linear track, thereby selectively preventing longitudinal displacement and rotation of the cylindrical shaft of the rigid endoscope or the flexible endoscope relative to the instrument body.

60. The instrument according to claim 59, wherein the linear track is provided such that the endoscope shaft guided and engaged by the track is disposed in proximity to the guide tube and parallel to the linear portion of the guide tube.

61. The instrument according to claim 59 or 60, wherein the linear track comprises a linear groove provided on the outer surface of the instrument body, the groove preferably having a depth of at least 1 mm, a width of 2 mm, and a length of at least 10 mm.

62. The instrument according to any one of claims 59 to 61, having a plurality of U-shaped or C-shaped or V-shaped guide elements arranged to form a linear track for guiding a part of the endoscope shaft.

63. The instrument according to any one of claims 59 to 62, wherein the linear track has a plurality of guide plates or walls sandwiching at least a part of the track, the guide plates or walls providing a guide surface facing the track, the guide surface including at least one linear element parallel to the linear portion of the guide tube.

64. The linear track is disposed at the distal grip portion of the instrument body. The linear track defines a first central axis parallel to the central axis of the guide tube, the instrument body having a proximal longitudinally extending portion having a linear drive member track for forward and backward movement of the balloon catheter, the proximal longitudinally extending portion of the instrument body having a second central axis, the second central axis being defined by the linear drive member track along which the drive member moves. The instrument according to any one of claims 59 to 63.

65. An angle is provided between the first central axis defined by the linear track and the second central axis defined by the linear drive member track. Preferably, the proximal longitudinally extending portion of the instrument body is supported by the linear track so as to move away from the central axis of the endoscope shaft in order to obtain a large amount of space at the proximal end of the rigid endoscope, and the angle is preferably 5-90 degrees, more preferably 10-60 degrees, and still more preferably 20-45 degrees. The instrument according to claim 64.

66. The instrument according to any one of claims 59 to 65, comprising an inflation / pressurization device for inflating and pressurizing the balloon catheter.

67. The instrument according to any one of claims 59 to 65, wherein the pressurization / inflation device comprises a syringe assembly, and the syringe assembly comprises a syringe barrel, a plunger rod, and a seal element.

68. A method for balloon dilating an eustachian tube or another anatomical passage accessible from a person's nose in the head of a person using a hand-held insertion instrument for balloon dilating the eustachian tube or another anatomical passage accessible from a person's nose, wherein the instrument comprises a balloon catheter, a balloon catheter guide tube for receiving and guiding the balloon catheter, and the balloon catheter has a distal inflatable portion and a proximal portion, the distal inflatable portion being an element that extends out of and advances from the distal end of the balloon catheter guide tube, and the proximal portion being fluidly connectable to an internal or external inflation / pressurization device for inflation and pressurization of the balloon catheter, and the instrument further comprises an instrument body fixedly connected to the proximal end of the guide tube, at least a part of the guide tube extending from the proximal end of the guide tube towards the distal end of the guide tube is linear, the instrument body is shaped and sized such that it can be held and operated by an operator, the instrument body is provided with a linear track configured to support and guide a part of the cylindrical shaft of a rigid endoscope or a flexible endoscope, the linear track extends parallel to the linear portion of the guide tube, and the method comprises a. disposing the endoscope shaft on or within the linear track on the instrument body of the balloon insertion instrument; b. Grasp the grip portion of the instrument body with any part of a finger or a single hand, press a part of the endoscope shaft against the linear trajectory of the instrument body, and fully support at least a part of the endoscope shaft; c. Simultaneously insert the guide tube of the insertion instrument and the endoscope shaft into a person's nostril; d. Once the position is confirmed in the visible image of the endoscope, advance the balloon from the tip of the guide tube into the anatomical passage to be expanded; e. Inflate the balloon to expand the anatomical passage; f. Deflate and retract the balloon; A method comprising the above.

69. After d) and before e), while slightly loosening the grip of the hand portion holding the endoscope shaft with respect to the linear trajectory, and further rotating the endoscope shaft or translating it inward or outward with the other hand to adjust the endoscope shaft with respect to the guide tube, the method according to claim 68.

70. An instrument for guiding a balloon catheter through the nostril to the opening of the eustachian tube, paranasal sinus, or other anatomical passage in a person's head, An instrument body connected to a rigid hollow balloon catheter guide tube, A balloon catheter having an inflatable distal portion and a proximal portion provided with a fluid connection port, Comprising: The proximal portion is formed as a cylindrical element configured to move linearly within the cylindrical cavity of the instrument body, One or more radial seal elements seal between the cylindrical element and the inner surface of the cylindrical cavity of the instrument body, The balloon catheter is retracted into the guide tube when the cylindrical element is in a first proximal position, The inflatable portion of the balloon catheter fully advances when the cylindrical element is in a second most distal position with respect to the cylindrical cavity of the instrument body, An instrument.

71. A thruster is connected to the cylindrical element within the instrument body, A sealed closed space within the cylindrical cavity of the instrument body adjacent to the cylindrical element defines a gas spring, The gas pressure within the gas spring is 1 atm absolute when the cylindrical element is in the first nearest proximal position, When a force is applied distally to the thruster to move the cylindrical element distally, a pressure of less than 1 atm absolute is formed in the gas spring. When the force applied to the thruster disappears, the pressure of the gas spring biases the cylindrical element proximally, thereby pulling the balloon catheter back proximally. The device according to claim 70.

72. Immediately after successful inflation, a port opens between the gas chamber and the balloon catheter, and a portion of the reduced pressure formed in the gas chamber is used for balloon deflation, after which the balloon is retracted into the catheter. The device according to claim 70 or 71.

73. A fluid connection port penetrating the wall of the device body radially is connectable to an external pressurizing device. The cylindrical element disposed within the cylindrical cavity of the device body functions as a valve for controlling the passage of fluid flowing from the fluid connection port through the cylindrical element into the balloon catheter. The cylindrical element blocks the passage of fluid through the balloon catheter when it is in the first position and any position between the first position and the second position. The cylindrical element allows fluid to pass from the fluid connection port into the balloon catheter only when it is in the second position. The device according to any one of claims 70 to 72.

74. An elastic element is disposed between the distal end of the cylindrical element and the most distal end of the cylindrical cavity. The elastic element is engaged immediately before the cylindrical element reaches the second position. Before the cylindrical element reaches the second position that allows fluid connection between the fluid connection port and the balloon catheter, the elastic element needs to be compressed, preferably the elastic element produces a clear tactile feedback to the operator. The device according to any one of claims 70 to 73.

75. The thruster is connected to the cylindrical element via a rod. This rod is sealed against an internal cylindrical cavity incorporated as part of the device body. The device according to any one of claims 70 to 74.

76. A system for inflating and pressurizing a balloon catheter, comprising a balloon catheter, and A distal syringe barrel portion having a distal opening for connection to a balloon catheter, a proximal thruster guide portion, and a syringe body having a shape that engages an external hand or finger. A plunger having a distal plunger head having a radial seal element for sealing against the inner surface of the syringe barrel, and a plunger rod. A thruster having an engagement portion with a finger or hand at its proximal end. A thruster rod A spring element Comprising The plunger head of the plunger is inserted into the syringe barrel portion of the syringe body. The thruster rod is inserted into the thruster guide portion of the syringe body. The spring element is disposed between the thruster and the plunger such that an axial external force applied to the thruster in the distal direction is transmitted to the plunger via the spring element. The thruster and the syringe body have locking means for locking the thruster in one exact axial position relative to the syringe body. System.

77. The locked position of the thruster relative to the syringe body holds the plunger in a specific position relative to the syringe barrel when the balloon is fully inflated, and the spring element acts on the plunger head with a specific force to generate a specific hydrostatic pressure required for the inflation procedure within the syringe barrel and the balloon. The system according to claim 76, wherein the spring element is held at a specific compressed length.

78. A pressure relief valve is in hydraulic communication with the water of the syringe assembly. When the hydrostatic pressure in the syringe barrel exceeds a specific pressure required for the inflation procedure, the pressure relief valve opens and discharges water. The system according to claim 76 or 77.

79. The plunger rod has an outer cylindrical diameter slightly smaller than the diameter of the inner cylindrical cavity of the thruster rod. The plunger rod is configured to move axially within the thruster rod cavity. A helical spring element is disposed on the plunger rod. An external force applied to the thruster in the distal direction is transmitted from the distal surface of the thruster rod through the helical spring to the plunger head. When an external force is applied to the thruster and the pressure within the syringe barrel rises, the helical spring is axially compressed. The system according to any one of claims 76 to 78.

80. Two seal elements are arranged proximal to the plunger rod and are configured to seal radially against the inner surface of the cylindrical cavity in the thruster rod, A first radial port on the surface of the plunger rod and arranged between the two radial seal elements is in fluid communication with the syringe barrel space via the internal axial lumen of the plunger, A second radial port in the thruster rod connects the inner surface of the cylindrical cavity in the thruster rod to the outer surface of the thruster rod, The second radial port is located at an axial position proximal to the most proximal radial seal element on the plunger rod only when the syringe assembly is in a first stage where the pressure in the syringe barrel is lower than a set value, When the pressure in the syringe barrel becomes higher than the set value, the plunger is further moved proximally relative to the thruster beyond the point where the most proximal radial seal element on the plunger rod passes through the second radial port, thereby forming an open fluid connection from the outer surface of the thruster rod, through the second radial port, through the first radial port, and through the axial lumen of the plunger to the syringe barrel space. The system according to any one of claims 76 to 79.

81. The thruster has an axial end stop that coincides with or is slightly distally located at the one exact axial position, and the locking means is preferably configured to automatically lock the thruster when the thruster reaches the axial end stop, and the locking means is more preferably configured to release the lock of the locked thruster when the thruster is pushed in the distal direction. The system according to any one of claims 76 to 80.

82. The locking means has one or more radial structures provided on the outer surface of the thruster rod and one or more opposing structures provided on the inner surface of one or more radially flexible and deformable portions of the thruster guide portion of the syringe body. The system according to any one of claims 76 to 81.

83. The locking means includes one or more internal axial ribs provided on the inner cylindrical surface of the thruster guide portion of the syringe body, and a two-part thruster rod having a proximal part and a distal part separate from each other and connected to the thruster engaging portion. The proximal part and the distal part have a cylindrical surface with a diameter slightly smaller than the diameter of the inner cylindrical surface of the thruster guide portion of the syringe body. The proximal part and the distal part have one or more axial grooves aligned with the axial ribs. The proximal thruster rod part has a plurality of angled cam surfaces at its distal end. A plurality of angled cam surfaces that fit precisely with the plurality of angled cam surfaces are provided at the proximal end of the distal thruster part. The angled cam surfaces are configured to convert the axial force from the proximal thruster part into the rotational force of the distal thruster part. The distal thruster part can rotate freely when passing through the end of the internal axial rib at a certain axial position. The cam surface of the distal thruster part has one or more axial grooves in the lower cam region every other one, and the cam surface of the distal thruster part has a locking surface configured to lock against the distal end of the axial rib in the lower cam region every other one. The axial external force from the finger hook portion of the thruster is transmitted from the proximal thruster part to the distal thruster part through the cam surface, and is transmitted from the distal surface of the distal thruster part to the plunger through the spring element. The distal thruster part is togglable between a state where it can move freely along the axial rib and a state where it is axially locked against the distal end of the axial rib. The system according to any one of claims 76 to 82.

84. The balloon catheter pressurizing device is pre-assembled and filled with liquid during manufacturing, and the system according to any one of claims 76 to 83.

85. It has a guide tube for inserting the balloon catheter into a person's nostril to expand the eustachian tube or the passage of the paranasal sinus. The balloon catheter is configured to move within the guide tube. The system according to any one of claims 76 to 84.

86. It includes a guide sheath for inserting the balloon catheter into a person's tube. The balloon catheter is configured to move within the guide sheath. The system according to any one of claims 76 to 85. **Claim 87** The system according to any one of claims 76 to 86, comprising a guide sheath for inserting the balloon catheter through a natural or artificial body opening into an arbitrary passage within the human body. **Claim 88** A method of inflating and pressurizing a balloon catheter for expanding a passage within a human body using the system according to any one of claims 76 to 87, the method comprising: a) In some embodiments, while the distal fluid connection port of the syringe body is connected to a liquid source, retracting the thruster from the most distal position to the most proximal position to draw the liquid back into the syringe barrel; b) In some embodiments, discharging air from the liquid within the passage to be expanded; c) In some embodiments, attaching the balloon catheter to the catheter connection port of the syringe body; d) Gripping the instrument with only one hand and pushing the thruster distally into the syringe body until it reaches a firm end stop position; e) Locking the thruster in one exact axial position relative to the syringe body; f) Releasing the lock of the thruster; g) Retracting the thruster to deflate the balloon. A method comprising the above steps. **Claim 89** A method of inflating and pressurizing a balloon catheter for expanding a passage within a human body using the system according to any one of claims 76 to 87, the method comprising: a) In some embodiments, while the distal fluid connection port of the syringe body is connected to a liquid source, retracting the thruster from the most distal position to the most proximal position to draw the liquid back into the syringe barrel; b) In some embodiments, discharging air from the liquid within the passage to be expanded; c) In some embodiments, attaching the balloon catheter to the catheter connection port of the syringe body; d) Gripping the instrument with only one hand and pushing the thruster distally into the syringe body until it reaches a firm end stop position such that the thruster is automatically locked; e) Pushing the same thruster distally again to automatically release the lock of the thruster. f) retracting the thruster to deflate the balloon; A method comprising the above. **Claim 90** A handheld insertion instrument for expanding an eustachian tube or paranasal sinus passage accessible from a person's nostril, the instrument comprising: A balloon catheter having an inflatable balloon distally and a fluid connection port proximally; A guide tube for inserting and guiding the balloon catheter; An instrument body attached to the guide tube; A drive member; Comprising; The guide tube has a proximal rigid portion and a distal deformable portion; One end of a pull wire disposed within the guide tube is fixedly attached to the guide tube at or near the distal end of the guide tube, and the other end is fixedly attached to the instrument body for fixing the pull wire. The guide tube can translate linearly relative to the instrument body along its axis; The drive member is connected to the proximal end of the guide tube; Movement of the drive member in the distal direction causes the guide tube to move distally relative to the instrument body and the fixed pull wire, thereby bending the deformable distal portion of the guide tube. Instrument **Claim 91** The guide tube has a steel tube with a proximal rigid portion and a distal deformable portion; A notch in the steel tube in the distal deformable portion allows the steel tube to flex on one flexure surface, the pull wire is preferably attached to the steel tube at a point distal from the notch by soldering or welding, distal movement of the steel tube relative to the pull wire preferably increases the deformation of the deformable portion, the drive member is preferably coupled to the proximal end of the steel tube, and the guide tube preferably comprises a flexible liner inside the steel tube for guiding the balloon catheter to protect the balloon catheter from the notch in the steel tube. The instrument according to claim 90. **Claim 92** The guide tube has a deformable tube having the balloon catheter lumen and the pull wire lumen. The deformable tube has its proximal end connected to the drive member of the instrument and its distal end fixedly attached to the pull wire. The deformable tube preferably has equal flexibility over its entire length. The guide tube preferably further has a rigid straight tube fixedly connected to the instrument body. To prevent the portion of the deformable catheter within the rigid straight tube from bending, and so that when the drive member, and thus the entire deformable tube, is advanced distally relative to the rigid straight tube and relative to the pull wire, a portion of the deformable tube extending from the distal end of the rigid straight tube can bend, the deformable tube is preferably guided within the rigid straight tube for linear movement. The instrument according to claim 90.

93. The guide tube of the instrument has a deformable tube having the balloon catheter lumen and the pull wire lumen. The guide tube of the instrument further includes a rigid straight tube, the deformable tube is attached and adhered to the rigid straight tube, one distal portion of the deformable tube extends from the distal end of the rigid straight tube, and one proximal portion of the deformable tube is positioned inside the rigid straight tube. One end of the pull wire is attached to the distalmost end of the deformable tube, and the other end is fixedly attached to the instrument body. The rigid straight tube can preferably translate linearly relative to the instrument body. The drive member is preferably attached to the proximal end of the rigid straight tube, and the forward distal movement of the drive member, and thus the rigid straight tube, relative to the instrument body and the pull wire causes the deformable portion of the deformable tube to curve. The instrument according to claim 90.

94. A hub is adhered to the proximal end of the guide tube. An elastic member is disposed between the hub and the instrument body, and when the deformable tube is pushed distally, the elastic member is preferably compressed or stretched. The instrument according to any one of claims 90 to 93.

95. The pull wire is attached to the distal end of the guide tube at a position less than 10 mm from the most distal position, and the pull wire is mechanically coupled to the guide tube on the distal side of the deformable portion, and the coupling is preferably performed by embedding the pull wire in the deformable guide tube material in the process of melting a part of the guide tube material around the pull wire, directly adhering to the guide tube, or directly welding or soldering the pull wire to the guide tube or the pull member, where the pull member may be a steel ring fixed to the guide tube on the distal side of the deformable portion. The instrument according to any one of claims 90 to 93.

96. Any curved state of the distal end portion of the guide tube can be locked by locking the drive member at one of several positions relative to the instrument body. The lock preferably includes a releasable one-way lock. The instrument according to any one of claims 90 to 95.

97. The one-way lock has a serrated surface along the drive member and an opposing serrated releasable cam of the instrument body. The distal movement of the drive member is enabled by the serrated cam. Proximal movement is not permitted by the cam. The cam is preferably releasable using a lever. The instrument according to claim 96.

98. The drive member of the instrument includes a first rotatable knob, and this rotatable knob is coupled to the proximal end of the guide tube via a tread interface. Rotation of the knob in one direction advances the guide tube distally, and rotation of the knob in the opposite direction retracts the guide tube proximally. The instrument according to any one of claims 90 to 95.

99. The guide tube is rotatably arranged relative to the instrument body for rotating the deflection surface. The instrument according to any one of claims 90 to 98.

100. It further includes a second drive member coupled to a guide wire disposed within the lumen of the balloon catheter. The distal movement of the second drive member advances the guide wire from the distal end of the deformable guide tube. The instrument according to any one of claims 90 to 99.

101. Comprising a third drive member coupled to the balloon catheter, Movement of the drive member distally causes the inflatable portion of the balloon catheter to advance from the distal end of the deformable guide tube. The instrument according to any one of claims 90 to 100

102. Comprising a fourth drive member coupled to a plunger of a syringe assembly connected to the instrument body, The syringe assembly is in fluid communication with the balloon catheter, Movement of the drive member distally causes the plunger to move relative to the syringe barrel to inflate the inflatable portion of the balloon. The instrument according to any one of claims 90 to 101

103. Preferably, a method of inserting and inflating a balloon catheter for expanding an eustachian tube, a paranasal sinus passage, or other passage in a human head accessible from a human nostril, using the instrument according to any one of claims 93 to 102, the method comprising: a) Rotating the guide tube of the instrument to a desired angle suitable for reaching the passage to be expanded, depending on the embodiment; b) Grasping the instrument with only one hand and inserting the straight guide tube into the human nostril; c) Pushing the first drive member distally using the thumb to bend the distal end of the guide tube along the passage to be expanded; d) Pushing the second drive member distally using the same thumb of the same hand to advance a guide wire into the passage, depending on the embodiment; e) Pushing the third drive member distally using the same thumb of the same hand to extend and advance the inflatable portion of the balloon catheter from the distal end of the guide tube; f) Pushing the fourth drive member distally using the same thumb of the same hand to inflate the inflatable portion of the balloon catheter, depending on the embodiment; g) Deflating and withdrawing the balloon once the expansion is complete; A method comprising.

104. A handheld insertion instrument for expanding an eustachian tube or a paranasal sinus passage in a human head accessible from a human nostril, the instrument comprising: A balloon catheter having an inflatable balloon on the distal side and a fluid connection port on the proximal side, A guide tube capable of inserting and guiding the balloon catheter, an instrument body attached to the guide tube, A first drive member connected to the proximal end of the mandrel, a second drive member connected to the proximal end of the balloon catheter; comprising; the first and second drive members are linearly slidable along the instrument body; the guide tube has a proximal rigid portion and a distal deformable portion; the guide tube has a lumen for guiding the balloon catheter and a lumen for guiding the mandrel; the mandrel has a curved and elastically flexible distal end, which has a higher rigidity than the distal deformable portion of the guide tube and a lower rigidity than the proximal rigid portion of the guide tube; the movement of the drive member from a first proximal position to a second distal position moves the curved tip of the mandrel from a retracted position inside the rigid portion of the guide tube to a forward position inside a part or all of the distal deformable portion of the guide tube, partially or completely deforming the distal deformable portion of the guide tube; instrument.

105. While the guide tube is in the patient's nose, the first drive member may be rotated to rotate the mandrel relative to the guide tube in order to operate the deflection surface and degree of deflection of the guide tube with a single drive member, the instrument according to claim 104.

106. Any deflection position and rotation position of the distal end of the guide tube are preferably automatically locked by the frictional force between the drive member and the path along which the drive member moves, or comprises a locking device configured to lock the position of the drive member; the instrument according to claim 104 or 105.

107. A handheld insertion instrument for expanding the eustachian tube or paranasal sinus passage of a human head accessible from a human nostril, the instrument comprising a balloon catheter having an expandable balloon on the distal side and a fluid connection port on the proximal side; a guide tube having a curved and flexible distal end, the guide tube for inserting and guiding the balloon catheter; a rigid straight tube surrounding a part of the axial range of the guide tube; an instrument body, preferably configured such that the instrument can be grasped by the hand of the operator of the instrument; a first drive member for moving the guide tube relative to the rigid straight tube; a second drive member connected to the proximal fluid connection port of the balloon catheter for advancing and retracting the balloon; comprising; The first and second drive members are guided to slide linearly along the instrument body, The first drive member in the first position causes the curved and flexible distal end of the guide tube to be completely drawn into the rigid straight tube, The first drive member in the second position causes the curved and flexible distal end of the guide tube to extend completely or partially from the distal end of the rigid straight tube, Instrument.

108. The first drive member is connected to the guide tube, and the rigid straight tube is fixedly connected to the instrument body, The first proximal position of the drive member causes the curved and flexible distal end of the guide tube to be completely drawn into the rigid straight tube, The second distal position of the drive member causes the curved and flexible distal end of the guide tube to extend completely or partially from the distal end of the rigid straight tube, The instrument according to claim 107.

109. The first drive member is connected to the proximal end of the rigid straight tube, The proximal end of the flexible guide tube is fixed to the instrument body, The first distal position of the drive member causes the curved and flexible distal end of the guide tube to be completely drawn into the rigid straight tube, The second proximal position of the drive member causes the curved and flexible distal end of the guide tube to extend completely or partially from the distal end of the rigid straight tube, The instrument according to claim 107 or 108.

110. A knob for rotating the guide tube is connected to the proximal end of the guide tube, The instrument according to any one of claims 107 to 109.

111. A single drive member may rotate and translate the guide tube relative to the rigid tube, and while the guide tube is in a patient's nose, the single drive member may manipulate the deflection surface and degree of deflection of the guide tube. The instrument according to any one of claims 107 to 110.

112. Any deflection position and rotational position of the distal end of the guide tube are preferably automatically locked by a high frictional force between the drive member and the path along which the drive member moves. The instrument according to any one of claims 107 to 111.

113. A handheld insertion instrument for balloon dilation of a human eustachian tube or other anatomical passage in the head, the instrument comprising A pressure-applying instrument connected to a movable member configured to be moved by fingers of an operator's hand holding the instrument, a balloon catheter, a guide tube for receiving and guiding the balloon catheter, and comprising, wherein the balloon catheter has a distally expandable portion that will emerge and advance from the distal end of the balloon catheter guide tube, and a proximal portion fluidly connected to the pressure-applying instrument for inflation and pressurization of the balloon catheter, the instrument further comprises a drive member coupled to the balloon catheter and configured to cause the distally expandable portion to emerge and advance from the distal end of the guide tube, the drive member also being coupled to the movable member, the movable member is configured to move substantially distally from a most proximal position to an intermediate position and from the intermediate position to a most distal position, the drive member is configured to cause the distally expandable portion to emerge and advance from the distal end of the balloon catheter guide tube when the movable member is moved from the most proximal position to the intermediate position, the pressure-applying instrument is configured to inflate and pressurize the balloon catheter when the movable member is moved from the intermediate position to the most distal position, instrument.

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