WO2020228726A1 - 冲鼻导管专用自动注射器及地毯式冲鼻法 - Google Patents

冲鼻导管专用自动注射器及地毯式冲鼻法 Download PDF

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Publication number
WO2020228726A1
WO2020228726A1 PCT/CN2020/089966 CN2020089966W WO2020228726A1 WO 2020228726 A1 WO2020228726 A1 WO 2020228726A1 CN 2020089966 W CN2020089966 W CN 2020089966W WO 2020228726 A1 WO2020228726 A1 WO 2020228726A1
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Prior art keywords
nasal
flushing
catheter
fluid
syringe
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PCT/CN2020/089966
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English (en)
French (fr)
Inventor
李子瑜
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通博国际有限公司
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Publication of WO2020228726A1 publication Critical patent/WO2020228726A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H35/00—Baths for specific parts of the body
    • A61H35/04—Baths for specific parts of the body for the nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor

Definitions

  • the invention discloses an auto-injector, in particular an auto-injector special for nasal flushing catheters, and a carpet type nasal flushing method using the auto-injector for nasal flushing catheters.
  • the applicant Since 2012, the applicant has been using the pre-marketing nasal catheter to spray multiple slender water columns perpendicular to the catheter to treat his chronic sinusitis, including changing the total area of the side holes and the perfusion rate to change the strength of the water column and the distribution of the side holes Range, and the special design of collapsible nose flushing catheter.
  • the average height of the water column is inversely proportional to the square of the total area of the side hole, and proportional to the square of the perfusion rate.
  • the catheters At a perfusion rate of 10cc per second, the catheters are divided into: 1. High-pressure catheters with an average vertical water column height of more than 90cm; 2 It can spray out medium-pressure pipes with an average vertical water column height of 45cm ⁇ 90cm; 3.
  • the flow rate is very fast during pressurized perfusion, which will produce turbulence and cause energy and pressure loss, so the pressure reading is not equal to the actual pressure of the lumen.
  • the vertical height of the water column is related to the lumen pressure, the lumen pressure affects the size of the side hole, the size of the side hole affects the resistance of the side hole, and the resistance of the side hole affects the height of the water column. Therefore, the vertical height of the water column is not directly proportional to the lumen pressure.
  • the collapsible nose flush catheter has a flat closed end, and the soft tube wall can collapse under pressure, because the flat closed end has a much smaller diameter than the proximal end, which has the advantages of large catheters, large flow and easy manipulation, and small catheters to enter Advantages of small gap-like space.
  • Various methods can improve the symptoms of nasal congestion. Among them, the collapsible nasal catheter is the best, but the nasal congestion will still recur at most one week, and the nasal catheter still needs to be cleaned. It is not the purpose of our previous invention to allow patients to use nasal flushing catheters endlessly, and we still need to find a better way.
  • the purpose of the present invention is to provide a special auto-injector for nasal flushing catheters and a carpet-style nasal flushing method.
  • the present invention provides a special auto-injector for nasal flushing catheter, which is used to connect a nasal flushing catheter with a closed end and a plurality of side holes.
  • the perfusion washing liquid sprays multiple slender water columns from the side holes for nasal flushing treatment.
  • the number of repeated perfusions can be set.
  • the automatic injector for nasal flushing catheter includes a flushing fluid source, a flushing fluid delivery device connected to the flushing fluid source, and a power unit connected to the flushing fluid delivery device.
  • the above-mentioned flushing liquid delivery device is a peristaltic pump.
  • the peristaltic pump includes a pump casing, an elastic tube arranged in the pump groove, a rotor arranged in the pump groove, and at least one roller arranged on the periphery of the runner .
  • One end of the elastic round tube is connected with the source of the flushing liquid, and the other end is connected with a nasal flushing catheter.
  • the power unit is used to precisely control the rotation speed, rotation cycles, pause time and repetition times of the peristaltic pump.
  • the peristaltic pump is used for precise, quantitative and constant-speed perfusion of flushing fluid to spray multiple slender water columns from the multiple side holes for nasal flushing treatment.
  • the flushing liquid delivery device described above includes a three-way connector, a syringe, and a power conversion unit.
  • the three-way connector is respectively connected with the flushing liquid source, the injection barrel, and the nose flushing catheter.
  • a one-way check valve is respectively arranged between the three-way connector, the source of the flushing liquid and the connection of the nasal flushing catheter.
  • the injection barrel is connected with the power conversion unit, and the power conversion unit is connected with the power unit.
  • the power unit can precisely control the rotation speed, the number of rotations, the pause time and the number of repetitions.
  • the circular motion of the power unit is converted into a linear reciprocating motion by the power conversion unit to drive the plunger of the syringe barrel to perform filling and suction irrigation liquid Actions.
  • the bending modulus of the elastic round tube is not more than 603 MPa, and the ratio of the outer diameter to the thickness of the tube wall is not more than 41.55.
  • the bending modulus of the elastic round tube is not more than 170 MPa, and the ratio of the outer diameter to the thickness of the tube wall is not more than 26.9.
  • the bending modulus of the above-mentioned elastic round tube is not more than 12 MPa, and the ratio of the outer diameter to the thickness of the tube wall is not more than 11.11.
  • the present invention also provides a carpet type nasal flushing method, which is suitable for using a nasal flushing catheter with a closed end and a plurality of side holes, and the above-mentioned special autoinjector for nasal flushing catheters.
  • the carpet-style flushing method includes an extension step, a catheter position confirmation step, a setting step, a filling and exit step.
  • the closed end of the nose flushing catheter enters the nasopharynx through a slit-like path from the nasal vestibule.
  • step of confirming the position of the catheter take an appropriate amount of flushing liquid and pressurize it into the nasal flushing catheter to confirm that the nasopharynx has a jet of water, or use an endoscope to confirm that a part of the side hole at the end of the catheter has entered the nasopharynx.
  • the nasal flushing catheter is connected to the dedicated autoinjector for nasal flushing catheters, and the executor sets the perfusion volume, perfusion speed, pause time, and repeated perfusion times on the dedicated autoinjector for nasal flushing catheters.
  • the automatic syringe for flushing the nasal catheter is used to perform multiple infusions, and the nasal flushing catheter is slowly withdrawn during the infusion process until the water column is sprayed out in the nasal vestibule to completely clean the place Mucus and booger through the path.
  • it also includes repeating steps, using the nose flushing catheter to enter the nasopharynx through other slit-like paths, and then repeating the catheter position confirmation steps, setting steps, perfusion steps, and exit steps to completely clean the mucus in the path. And booger.
  • the nose flushing catheter has a flat closed end.
  • the beneficial effect of the present invention is that the auto-injector can completely replace the performer to perform an unlimited number of perfusion actions, and quickly clean the mucus and nose in the path of the catheter; the carpet-style flushing method can clean all the nasal space and effectively improve Symptoms of nasal congestion benefit the patient.
  • Figure 1 is a coronal cross-sectional view of the posterior 1/3 of the nasal cavity of a patient with stenosis chronic sinusitis, illustrating the shape of the turbinate larger than the nasal passage;
  • Figure 2 is a schematic side sectional view illustrating the shape of the collapsible nose flushing catheter with a flat closed end
  • Figure 3 is a schematic cross-sectional view illustrating the state where the flat closed end is placed upright
  • Figure 4 is a schematic cross-sectional view illustrating the horizontal placement of the flat closed end
  • Figure 5 is a side cross-sectional view of the nasal cavity of a human body, illustrating the configuration of a flush nasal catheter extending upward in the nasal vestibule at a large angle;
  • FIG. 6 is a cross-sectional view of the human nasal cavity, illustrating the shape of the nose punching catheter extended into the nasal vestibule at a large angle, bending the part outside the nose punching catheter so that the front end of the nose punching catheter enters the nasopharynx through the space above the nasal cavity in a horizontal direction;
  • Figure 7 is a coronal section at the rear 1/3 of the nasal cavity of a patient with obstructive chronic sinusitis, indicating that mucus and nasal excrement accumulate from top to bottom, almost completely obstructed, with only some gaps left;
  • Figure 8 is a schematic diagram of a device, illustrating a form of infusing a flushing fluid into a nasal flushing catheter with a peristaltic pump to spray multiple elongated water columns;
  • Figure 9 is a schematic diagram of a device, illustrating a syringe driver with a linkage mechanism to drive the plunger of the syringe to suck flushing fluid into the syringe;
  • Figure 10 is a schematic diagram of the device, illustrating the syringe driver with a linkage mechanism to drive the plunger of a syringe, infusion of irrigation fluid sprays multiple slender water columns from the side hole of the nose tube;
  • Figure 11 is a schematic diagram of a device, illustrating a syringe drive with a cam mechanism to drive the plunger of the syringe to suck flushing fluid into the syringe;
  • Figure 12 is a schematic diagram of the device, illustrating that the syringe driver drives a plunger of a syringe with a cam mechanism, and the perfusion flushing liquid sprays multiple slender water columns from the side holes of the nose tube;
  • Figure 13 is a schematic diagram of a device, illustrating a fluid control valve in a first position to control fluid to enter a first space of a piston module, and to make a piston push rod of the piston module pull the push rod out of the syringe;
  • FIG. 14 is a schematic diagram of the device, illustrating the fluid control valve in the second position to control fluid to enter a second space of the piston module, and the piston push rod of the piston module pushes the push rod into the syringe;
  • Figure 15 is a schematic diagram of a device, illustrating the fluid control valve in the third position, and stop the flow of fluid to suspend the movement of the push rod;
  • Figure 16 is a side cross-sectional view of the nasal cavity of a human body, illustrating the shape of a nasal flushing catheter spraying multiple elongated water columns in the nasopharynx;
  • Figure 17 is a side cross-sectional view of the human nasal cavity, illustrating the shape of the nasal flushing catheter spraying multiple elongated water columns in the nasal vestibule;
  • Figure 18 is a flowchart of the carpet-style flushing method of the present invention.
  • Chronic sinusitis can be divided into two types: stenosis and obstruction based on computed tomography images.
  • FIG. 1 is a coronal cross-sectional view of the rear third of the narrow nasal cavity.
  • the nasal cavity is a triangle with a height of about 4cm ⁇ 5cm and a base of 3cm.
  • Three nasal passages are separated by three plate-shaped turbinates. And a temporary septal space, the surface area of which is much wider than that of the tubular structure.
  • the mucus discharged from the sinuses forms a thin layer on the surface of the nasal cavity, and then dries into a thin layer of nasal feces. Repeatedly, finally resulting in the form of a huge nasal passage with a narrow nasal passage.
  • the turbinate is smaller or the same as the nasal passage.
  • Figure 2 Figure 3, Figure 4, which is a collapsible nose flushing catheter.
  • 2 illustrates the collapsible nasal flushing catheter with a flat closed end
  • Figures 3 and 4 show the flat closed end upright and horizontally. Because the flat closed end is much smaller in diameter than the proximal end, the soft tube wall can collapse under pressure.
  • the collapsible nose flushing catheter has the advantages of large catheters, large flow and easy manipulation, and also has the advantages of small catheters entering small gap-like spaces. Therefore, it is easy to enter the nasopharynx through the nine narrow slit-like paths mentioned above.
  • Flat closed end if placed upright, it can pass through narrow gap-like spaces on the left and right, such as upper adjacent septum space 12, middle adjacent septum space 13, lower adjacent septum space 14, middle nasal passage vertical section upper half 15,
  • the lower half 16 of the vertical section of the middle nasal passage and the vertical section 18 of the lower nasal passage if placed horizontally, it can pass through narrow gap-like spaces, such as the horizontal section 17 of the middle nasal passage and the horizontal section 19 of the lower nasal passage.
  • FIG. 5 and Fig. 6 side cross-sectional views of the nasal cavity. It must enter the nasopharynx through the upper adjacent septum space 12, the upper nasal passage 11, or the upper half of the vertical section of the middle nasal passage 15 to enter the nasopharynx. A small angle is insufficient for height, and an upward angle is too large. Because the nasal cavity is a space with a narrow upper and lower gap, it is easy to get stuck in a narrow space. When the catheter is pushed from the outside, the catheter cannot be advanced and will only bend in the nasal cavity and cannot enter. Nasopharynx. Because the catheter is very soft and does not cause pain, the performer cannot recognize that the catheter is bent in the nasal cavity.
  • nasal flushing can be performed at this time, a lot of the nasal cavity surface will be missed. This is because the nasal congestion has not improved as expected in the past few years, and it is easy to relapse The reason, and therefore, is doubtful about the efficacy of nasal flushing, but after successful experience of carpet flushing, the applicant is convinced that the nasal congestion of chronic sinusitis has only one simple disease mechanism (pathophysiology, or pathophysiology): mucus and nose The physical properties of feces change and accumulate in the nasal cavity, any treatment should be based on this disease mechanism.
  • pathophysiology or pathophysiology
  • the flat closed end of the catheter can be placed upright against the nasal septum.
  • the lower adjacent septum space 14 directly extends in the horizontal direction
  • the middle adjacent septum space 13 slightly upwards about 2cm and then directly extends into the nasopharynx 52; if you want to pass through the upper adjacent diaphragm space 12, it will move upward about 3cm.
  • the catheter outside the nasal vestibule is bent and then slowly pushed in, then the arc-shaped catheter can guide the foremost end to a horizontal direction and continue to extend into the nasopharynx 52.
  • the flat closed end can be turned outward to pass through the upper nose.
  • the passage 11 extends into the nasopharynx 52; if you want to pass through the lower nasal passage horizontal section 19, you only need to put the catheter close to the bottom of the nasal cavity slightly outward, and place the flat closed end horizontally to directly extend into the nasopharynx 52; if you want to pass the lower nose.
  • the vertical section of the passage 18, the catheter is closer to the bottom of the nasal cavity, and the flat closed end is placed upright to enter the nasopharynx 52; if you want to pass through the horizontal section of the middle nasal passage 17, it is about 1.5cm upwards and slightly outward from the nasal vestibule.
  • the horizontal section does not have the problem of being stuck in a narrow space; if you want to pass through the lower half of the vertical section 16 of the middle nasal passage, you need to place the flat closed end upright.
  • After 1.5cm bend the catheter outside the nasal vestibule and slowly push it into the nasopharynx 52; pass through the upper half 15 of the vertical section of the middle nasal passage, and place the flat closed end upright 2.5cm upwards and outwards. Then bend the catheter outside the nasal vestibule and slowly push it in to enter the nasopharynx 52 through a horizontal path.
  • the nasal flushing catheter should enter the nasopharynx through all the above spaces, rather than only entering these spaces. This is the secret of the successful carpet flushing method.
  • the catheter After the catheter enters the nasopharynx from the above-mentioned path, start to infuse vigorously with a 10cc syringe.
  • the multiple elongated water jets sprayed from the side holes are cleaned.
  • the catheter is slowly withdrawn until the water jets can be sprayed in the nasal vestibule. If each path is infused with a syringe more than ten times, it can ensure that no place is missed, including the last end of the three turbinates. This is the place that needs cleaning after the nasal congestion is improved, because the mucus will move to the last end of the turbinate in the prone position. Sleep occupies one-third of the time, so it is easy to cause mucus and nose to accumulate.
  • FIG. 7 This is the coronal section of the rear third of the obstructive nasal cavity, indicating that mucus and nose are almost completely blocked from top to bottom, leaving only the nose There are still gaps in the horizontal section 19 of the passage.
  • This type can only place a nasal flushing catheter into the nasopharynx from the gap below. Firstly, clean the mucus and booger under the nasal cavity, gradually expand the breathing passage, and then place the nasal flushing catheter from the opened breathing passage to clean the mucus and snot above.
  • This obstructive type is different from the narrow type and cannot clean all the nasal space at once.
  • obstructive chronic sinusitis In obstructive chronic sinusitis, the remaining air passage under the nasal cavity is not necessarily slit-shaped, and it does not necessarily need a flat-shaped closed-end collapsible nasal nasal catheter, or a round-end nasal nasal catheter.
  • Obstructive chronic sinusitis has more mucus and nose than stenotic chronic sinusitis, requires more infusions and treatments, and requires automatic injectors to replace manpower.
  • the carpet flushing method can restore to the original condition of chronic sinusitis without nasal congestion. In this case, troublesome catheter flushing can be avoided, and you can sleep normally, but because the sinuses keep producing mucus, you still need to wash frequently with bare hands when you are awake
  • the nasal method cleans the mucus newly discharged into the nasal cavity from the sinuses to prevent the mucus from drying out into nose. If the nose feces accumulate to a certain thickness, if the bare-hand nose flushing method is invalid, then the carpet flushing method is required.
  • the free-hand nasal washing method is a nasal washing method that is easy to learn without any tools. Use one hand to make a cup to fill the rinsing liquid, cover one nostril, and the other hand to press the other nostril, head down as far as possible, and then inhale strongly to cup the hand.
  • the flushing fluid is sucked from the nasal cavity and discharged from the nasopharynx. You will be proficient in practicing a few times. With the head facing down, the washing fluid enters the nasopharynx from the top of the nasal cavity, and the air is sucked into the nasopharynx from the lower part of the nasal cavity and then enters the trachea, so it does not affect breathing.
  • the mucus will only move back and forth, not downwards, because the width of the slit-like space of the same height is the same, the mucus does not become a thin layer but maintains the shape of water droplets, and the contact area with air It is much smaller than the thin layer, and even completely blocks the air circulation, so it is not easy to dry, and it can be washed after waking up.
  • the turbinate plus mucus occupies a large volume and the nasal passage is very small, but the soft tissue of the nasal concha and the air space of the nasal passage are approximately equal when there is no nasal congestion after the treatment of the nose catheter
  • the flushing fluid of the hand cup does not exceed 25cc, and the head is facing down, and the oropharynx and nasopharyngeal above the trachea above the pharyngeal cartilage are approximately 3cm*3cm*7cm tubular structures.
  • the volume of 63cc is much larger than 25cc, and the flushing fluid only reaches The nasopharynx will not cause choking.
  • the hand-washing method is easy to learn, it is only suitable for patients with unobstructed nasal cavity, because only when the nasal cavity is unobstructed and there is no considerable thickness of nasal excrement, the washing liquid can smoothly enter the nasopharyngeal space to clean the mucus at the end of the turbinate.
  • the nasal cavity needs to be cleaned frequently, there is no need to remove the turbinate, and the structure of the nasal cavity can be preserved. This should be the best result of severe sinusitis that the medical profession can imagine.
  • the traditional nasal flushing treatment is a home treatment performed by the patient himself for life.
  • the nasal flushing catheter is designed to improve the efficacy of the traditional nasal flushing device, so the patient also needs to perform it for life.
  • the repeated suction and forced perfusion required to treat many patients is still a great burden. If there is an automatic injector, this time-consuming and labor-intensive work can be replaced.
  • the number of perfusions for each path can be increased again. The more the number of flushes, the better the effect.
  • the number of treatments of the carpet flushing method may be shortened to a reasonable range, which will become the standard treatment performed by the doctor instead of the operation. This is a big deal for the patient. Gospel.
  • Navage Nasal Care (Navage Nasal Care, which can be viewed through the following website: https://www.navage.com/v/navage-owners-manual-2017.pdf).
  • This electric nasal washing device has two upper and lower reservoirs connected to two nozzles with nose pillows. The two nasal pillows can block the nostrils and avoid the outflow of washing fluid.
  • One side is a passive suction port and the other is Active suction outlet.
  • the active suction outlet uses electric suction to suck one nostril to produce negative pressure, and then to the other nostril to produce a gentle suction force (gentle power suction).
  • the passive suction port sucks the washing liquid in the upper liquid storage cylinder, and the washing liquid flows into the nasal cavity. Then from the nasopharynx through the active suction port on the other side of the nasal cavity, it flows into the lower reservoir.
  • the nasal flushing catheter must have accumulated back pressure to spray multiple slender water columns of nearly average strength from most of the side holes to ensure the flushing effect, the back pressure is that the total area of the side holes is smaller than the cross-sectional area of the inner cavity, resulting in the lumen The inflow is greater than the outflow of the side hole.
  • a low-pressure nasal flushing catheter the total area of the side holes is large, and the vertical height of the water column is 30cm-45cm
  • Commercially available electric nasal washers can only produce gentle low-pressure water flow.
  • the height of the water column can only be set to 2.5cm (about 1 inch).
  • the automatic injector special for nasal flushing catheter of the present invention can be divided into two types: a peristaltic pump type and a syringe type.
  • a peristaltic pump type special autoinjector 2 for nasal flushing catheters has a flushing fluid source 21, which can be a liquid reservoir or a medical saline package.
  • a peristaltic pump 22 and a power unit 23 (such as a motor) that can precisely control the speed and rotation angle.
  • the peristaltic pump 22 has a pump casing 222 (pump casing), an elastic round tube 221, and a rotor 223 (rotor).
  • the rotating wheel 223 is provided with at least one roller 224 (roller), and the power unit 23 can rotate the rotating wheel 223.
  • One end of the elastic round tube 221 is a water inlet 225, the water inlet 225 can be connected to the flushing fluid source 21, the other end of the elastic round tube 221 can be connected to a water outlet 226, the water outlet 226 can be connected to a one-way check Valve 24 (check valve), the water outlet 226 can be connected to a luer connector, and then an extension tube is used to connect the nose flushing catheter 3.
  • the power unit 23 has a large torque at a low speed, and can drive the peristaltic pump 22 to push the flushing liquid to produce a perfusion rate of 5 cc-20 cc per second.
  • the roller 224 rolls from the water inlet 225 to the water outlet 226 to squeeze the washing liquid in the elastic tube 221 to flow out to the water outlet 226.
  • the elastic round tube 221 behind the roller 224 automatically expands and returns to its original shape due to its own elasticity, generates negative pressure and attracts the washing liquid in the washing liquid source 21 to fill the elastic round tube 221 again, and at the same time the unidirectional check of the water outlet 226
  • the valve 24 is closed due to the internal negative pressure of the elastic circular tube 221, which can prevent the fluid outside the water outlet 226 from flowing backward.
  • the peristaltic pump type special autoinjector for nasal flushing catheter can be divided into an intermittent supply type (not shown) and a continuous supply type.
  • the intermittent supply type peristaltic pump 22 has a semicircular elastic tube 221, a runner 223 and a roller 224.
  • the filling volume is preferably 10cc each time. Since the power unit 23 only has a half turn per revolution to compress the elastic tube 221, the elastic tube 221 in the pump groove 222 The volume is preferably 10cc. Assuming that the power unit 23 drives the peristaltic pump 22 at a speed of 15 revolutions per minute, and it takes 40 seconds to continuously rotate 10 revolutions, it takes 4 seconds for the power unit 23 to drive the peristaltic pump per revolution and 2 seconds for a half revolution.
  • the special auto-injector 2 for nasal flushing catheter supplies 10 cc of irrigation fluid at a speed of 5cc/sec, and rests for 2 seconds, so that it can be intermittently infused for 10 times in 40 seconds; suppose the power unit 23 drives the peristalsis at a speed of 30 revolutions per minute For the pump 22, it takes 20 seconds to continuously rotate for 10 revolutions, then the power unit 23 drives the peristaltic pump 22 for 2 seconds per revolution, and 1 second for a half revolution, then the special auto-injector 2 for nasal flushing catheter runs at a speed of 10cc/sec. Supply 10 cc of flushing fluid, and rest for 1 second. It takes 20 seconds for 10 intermittent infusions.
  • the power unit 23 rotates the peristaltic pump 22 at 45 revolutions per minute, and it takes 13.3 seconds to continuously rotate 10 revolutions, then the power unit 23 It takes 1.33 seconds to drive the peristaltic pump 22 for one revolution and 0.66 seconds for a half revolution.
  • the special auto-injector 2 for nasal flushing catheter supplies 10 cc of irrigating fluid at a speed of 15 cc/sec, and rests for 0.66 seconds, so intermittent infusion 10 Each time takes 13.3 seconds; assuming that the power unit 23 drives the peristaltic pump 22 at a speed of 60 revolutions per minute, and it takes 10 seconds to continuously rotate 10 revolutions, it takes 1 second to drive the peristaltic pump 22 per revolution and 0.5 half revolutions. Second, the syringe supplies 10 cc of flushing fluid at a rate of 20 cc/sec, and rests for 0.5 seconds. In this way, it takes 10 seconds for 10 intermittent infusions.
  • the continuous supply type has a plurality of rollers 224 and one or more runners 223.
  • the power unit 23 rotates the peristaltic pump 22, water is continuously discharged.
  • the peristaltic pump 22 outputs water twice every time the elastic tube 221 rotates.
  • the number of continuous rotation cycles of the unit 23 can control the water output, so the volume of the elastic tube 221 is not necessarily 10 cc, but can be any value.
  • the special auto-injector 2 for nasal flushing catheter supplies 10 cc of irrigating fluid at a speed of 5 cc/sec; suppose the power unit 23 rotates the peristaltic pump 22 at a speed of 60 revolutions per minute, and the peristaltic pump 22 rotates 1 revolution every 1 second , The special auto-injector 2 for nasal flushing catheter supplies 10 cc of flushing fluid at a speed of 10 cc/sec; suppose the power unit 23 rotates the peristaltic pump 22 at a speed of 90 revolutions per minute, and the peristaltic pump 22 rotates 1 revolution every 0.66 seconds , The special auto-injector 2 for nasal flushing catheter supplies 10 cc of irrigation fluid at a speed of
  • any pause time can be set after the irrigation fluid is supplied, and the cycle of perfusion and pause can be repeated accordingly.
  • Both of the above-mentioned two types of peristaltic pump-type autoinjectors 2 for nasal flushing catheters can be programmed, and one process is preferably intermittent infusion 5 to 15 times, and the executor (patient or physician) can freely choose.
  • the elastic tube 221 After the intermittent supply type roller 224 is rolled, the elastic tube 221 immediately returns to its original shape, and the flushing fluid almost follows the roller 224 and immediately fills the elastic tube 221. Even without the one-way check valve 24, the contents of the nose tube 3 flow backward There are few opportunities for the elastic tube 221; when the first roller 224 rolls to the water outlet end, the second roller 224 has also reached the water inlet end to press the elastic tube 221 to produce positive pressure to the water outlet end, even if there is no With the one-way check valve 24, there will be no negative pressure to suck the contents of the nasal flushing catheter 3 back into the elastic catheter; and the syringe is used to flush the nasal cavity instead of the blood vessel. A small amount of air entering the elastic round tube 221 does not need to be completely prohibited Therefore, the one-way check valve 24 between the elastic round tube 221 and the nose tube 3 is not indispensable.
  • the elastic round tube 221 in the pump groove 222 is a semicircle as an example, it is not limited to a semicircle in actual implementation, and can be any shape smaller than a full circle, as long as The elastic circular tube 221 can be arranged in a smooth shape without affecting the smooth rolling of the roller 224, and intermittent filling can be achieved by the rotation and suspension of the power unit 23.
  • flexible round tubes 221 with different volumes can be selected, and the rotation speed of the power unit 23 can be changed to find the best solution.
  • the source 21 of the rinsing solution can be warm water or physiological saline, and its capacity can be any number, preferably 1000cc-2000cc.
  • the general peristaltic pump 22 has the advantages of accurate quantitative, constant speed and accurate repeated perfusion, its elastic tube 221 cannot be used in a high-pressure environment. The reason is that the elastic round tube 221 will expand under high pressure. When the flushing fluid accumulates in the elastic round tube 221, it will cause insufficient perfusion speed and volume. The solution is to use an elastic circle with an acceptable expansion rate. Pipe 221.
  • Ebend in the flexural modulus formula Ebend L3F/4wh3d refers to the ratio of stress to strain obtained in the bending deformation of a material or in a three-point test of a rectangular beam.
  • w is the width
  • h is the height
  • L is the distance between the two outer support points
  • d is the deformation caused by the force F in the middle.
  • the expansion of a round pipe by the perfusion pressure can be regarded as a variation of this formula
  • the length (L) can be regarded as the diameter (outer or inner diameter) of the round pipe
  • the stress (F) can be regarded as the pressure inside the round pipe
  • the width (w) can be regarded as The length of the tube
  • height (h) can be regarded as the thickness of the tube wall
  • d can be regarded as the expansion of the radius of the tube (extension), and the expansion of the diameter is 2d.
  • the flexural modulus Ebend is proportional to the third power (L/h) 3 of the ratio of the outer diameter tube wall thickness.
  • the length w of the round tube (only the pump and the water outlet are affected by pressure, and the part at the water inlet is not affected) is inversely proportional to the expansion (d), while the length of the tube is directly proportional to the volume of the lumen. The two factors cancel each other out. Therefore, the length of the round tube does not affect the volume expansion ratio and can be ignored.
  • the inner diameter becomes an expanded tube of 8.8mm
  • the above can prove that the increase or decrease of the length of the round tube does not affect the volume expansion of the round tube, so it can be ignored. Therefore, the volume expansion rate of the elastic round tube 221 completely depends on the ratio of the outer diameter to the wall thickness.
  • Embodiment 1 Calculation of the outer diameter and the thickness of the tube wall of an elastic round tube of the same material.
  • the carpet flushing method no longer relies on the strong water column, but relies on the tube to extend into the narrow space in the horizontal direction, and then use the vertical water column to directly flush the mucus and booger on both sides of the nasal air passage, so only low pressure water column is enough.
  • the high-pressure nasal flush catheter 3 has the largest cumulative back pressure and the largest expansion rate; the low-pressure nasal flush catheter 3 has the smallest cumulative back pressure and the smallest expansion rate; in order to calculate the minimum requirement for the elastic catheter 221, that is, the maximum outer diameter and The pipe wall thickness ratio or the minimum pipe wall thickness to outer diameter ratio, the applicant uses PEBAX-2533 (polyether block amide-2533) with a flexural modulus of 12 MPa, where polyether block amide is a type of thermoplastic elastomer, including a series of groups, such as PEBAX-2533, PEBAX-3533, PEBAX-4533, PEBAX-5533, PEBAX7033, PEBAX-7433, etc., not limited to this)
  • PEBAX-2533 polyether block amide-2533
  • PEBAX-3533 polyether block amide
  • PEBAX-4533 PEBAX-5533
  • PEBAX7033 PEBAX-7433
  • the vertical height of the sprayed multiple slender water columns is about 30cm. Therefore, the pressure of the flushing catheter 3 above 1ATM meets the flushing requirements. Because the multiple slender water columns in the jet will cause the bounce of the catheter to interfere with the measurement of the outer diameter of the catheter, the outer diameter of the catheter is 2.10mm when a catheter with the same size without side holes is connected to the pressure gauge and filled with air to 1ATM.
  • Example 2 Calculation of the wall thickness ratio (L/h) of the outer diameter tube with different flexural modulus under the condition of 1ATM.
  • the flexural modulus is 21MPa
  • the third embodiment the required outer diameter to thickness ratio (L/h) for the internal pressure (F) of different elastic round tubes 221.
  • 3ATM is 3 times that of 1ATM, and the cube root of 3 is about 1.442.
  • the syringe type special auto-injector 4 for nasal flushing catheter can also infuse the flushing liquid accurately and quantitatively at a constant rate, producing a perfusion rate of 5cc-20cc per second.
  • This nasal flushing catheter is dedicated
  • the autoinjector 4 includes a flushing fluid source 41, a three-way connector 42, a syringe 43, and a syringe driver 46; the syringe driver 46 includes a power unit 44 and a power conversion unit.
  • the power unit 44 is a motor for driving the power conversion unit 45;
  • a one-way check valve 24 is provided between the three-way connector 42 and the washing liquid source 41, and the three-way connector 42
  • a one-way check valve 24 is provided between the nose flushing catheter 3 and the other direction of the three-way connector 42 is connected to the syringe 43.
  • the apertures of the side holes 31 on the nasal flushing catheter 3 are very small, when the syringe 43 sucks the flushing liquid, the tube wall of the nasal flushing catheter 3 will collapse and be closed. The amount of sucked air is very small, so the one-way check valve 24 may not be provided between the nose flush tube 3 and the three-way connector 42, and should not be limited to this.
  • the power conversion unit 45 can convert the circular motion of the power unit 44 into a linear reciprocating motion, so as to drive the push rod 431 of the syringe 43 to perform the actions of filling and sucking the irrigation liquid.
  • the power conversion unit 45 may be a link mechanism ( Figure 9 and Figure 10) or a cam mechanism ( Figure 11 and Figure 12).
  • the one-way check valve 24 connected to the connector of the flushing fluid source 41 is closed, and the connection to the nose tube 3 is connected
  • the one-way check valve 24 of the device is opened, so the flushing liquid flows into the nose flushing catheter 3, and multiple elongated water columns are sprayed from the side hole 31 (shown in Figs. 10 and 12).
  • the power unit 44 has a large torque when the rotation speed is low, and can precisely control the rotation speed, the number of rotation cycles, the pause time and the number of repetitions, and can achieve the purpose of perfusing the flushing liquid at a constant rate and the number of repetitions.
  • this syringe-type special autoinjector 4 for nasal flushing catheter can also infuse flushing liquid accurately and at a constant rate, producing a perfusion rate of 5cc-20cc per second, including a flushing liquid source 41, A three-way connector 42, a syringe 43, and a fluid power control system (fluid power control system) 6.
  • the fluid power control system has a power unit 61 and a directional control unit (directional control unit) 62 and an actuation unit 63.
  • the fluid 64 is a liquid
  • the power unit 61 can be a motor with a water pump, or other power facilities, but not limited thereto.
  • the directional control unit (directional control unit) 62 has a directional control module 621 and a three-position four-way fluid control valve 622, and the directional control module 621 can control the open, close and pause time of the fluid control valve 622.
  • the direction control unit 62 can accurately control the valve opening, time and size of the three-position four-way fluid control valve 622 to achieve the purpose of accurately controlling the flow rate and flow of the fluid 64.
  • the function unit 63 has a fluid storage tank 631 for storing fluid 64 and a piston module 632.
  • the piston module 632 has a cylinder 6321 in which there is a piston 6322 and a piston rod 6323 connected to the piston 6322 and protruding from the cylinder 6321.
  • the space in the cylinder 6321 The piston 6322 is divided into a first space (first space) 6324 and a second space (second space) 6325, and a return line 633 and a pressure line 634 are respectively connected to the fluid storage Box 631.
  • the piston push rod 6323 is used to connect the push rod 431 of the syringe 43 and perform the actions of sucking and filling the flushing liquid in a linear reciprocating motion.
  • the fluid 64 enters the first space 6324 from the valve of the three-position four-way fluid control valve 622 through the pressure pipe 634, and pushes
  • the piston 6322 and the piston push rod 6323 move backwards linearly to drive the syringe 43 to perform the action of sucking the rinsing liquid from the rinsing liquid storage cylinder.
  • the one-way check valve connected to the connector of the nasal flushing catheter 3 The 24 is closed to avoid sucking air into the syringe 43.
  • the fluid 64 in the second space 6325 flows back into the fluid storage tank 631 through the return pipe 633.
  • fluid 64 enters the second space 6325 from the valve of the three-position four-way fluid control valve 622 through the pressure pipe 634 to push The piston 6322 and the piston push rod 6323 move straight forward.
  • the one-way check valve 24 connected to the connector of the nose tube 3 is opened, and the syringe 43 performs the action of infusing the flushing fluid, and is connected to the The one-way check valve 24 of the three-way connector 42 of the flushing fluid source 41 is closed to prevent the flushing fluid from flowing back into the flushing fluid source 41.
  • the fluid 64 in the first space 6324 flows back into the flushing fluid source 41 through the return pipe 633.
  • Fluid storage tank 631 Fluid storage tank 631.
  • the direction control module 621 controls the fluid control valve 622 at the third position, the fluid 64 in the pressure pipe 634 and the return pipe 633 stops flowing, and the first space 6324 and the second space 6325 are not The fluid 64 is entering and exiting, so the piston push rod 6323 stops moving, and the syringe 43 also stops sucking or injecting flushing fluid.
  • the direction control module 621 can control the pause time.
  • the pressure of the power unit 61 minus the resistance of the fluid path, the resistance of the piston movement, the resistance of the syringe and the back pressure of the flushing catheter is equal to the net pressure of the entire hydrodynamic control mechanism.
  • This net pressure can determine the flow rate of the fluid 64.
  • This flow rate It can also determine the displacement speed of the piston push rod and the injection speed of the syringe; the flow rate of the fluid 64 multiplied by the valve opening time is equal to the flow of the fluid 64, which can determine the displacement of the piston push rod 6323 and the injection barrel 43 Infusion.
  • the fluid power control mechanism 6 can push the fluid 64 into the action unit 63 via the direction control unit 62 via the power unit 61, and drive the piston push rod 6323 of the piston module 632 to perform linear reciprocating motion to drive the syringe 43 to perform pumping.
  • the action of sucking and injecting the flushing fluid and can inject the flushing fluid at a quantitative and constant rate, and can also set the pause time and the number of repetitions to achieve the purpose of automatic flushing.
  • a one-way check valve 24 is also provided between the three-way connector 42 and the flushing fluid source 41, and between the three-way connector 42 and the flushing tube 3
  • a one-way check valve 24 is provided, and the other direction of the three-way connector 42 is connected to the syringe 43.
  • the three-way connector 42 connected to the conduit does not necessarily have the one-way check valve 24.
  • the fluid power control mechanism 6 is a technology for controlling the flow direction of the fluid 64.
  • the fluid 64 is a liquid.
  • the fluid 64 may also be a gas, and the power unit 61 It can be a motor with an air pump, but it should not be limited to this.
  • the rinsing solution can be warm water or physiological saline, and its volume can be any number, preferably 1000cc-2000cc.
  • Figure 1 is a carpet-style nose flushing method
  • the carpet-style nose flushing method includes a step 901, a catheter position confirmation step 902, a setting step 903, a filling and exiting step 904, and a repeating step 905.
  • Figures 16 and 17 show that the nasal cavity is divided into multiple narrow spaces by the upper turbinate F, the middle turbinate G, and the inferior turbinate H.
  • the carpet-style flushing method uses a soft nasal flushing catheter with closed ends and multiple side holes 3.
  • the nasal flushing catheter 3 can be collapsed, and the nasal flushing catheter special auto-injector 2 and 4 can be used to spray multiple elongated water columns in the nasal cavity.
  • the closed end of the nose flushing catheter 3 enters the nasopharynx 52 from the nasal vestibule 51 through the slit-shaped nasal passage. Because the soft nasal flushing catheter 3 can be bent in the slit-shaped nasal cavity, and its end position cannot be judged by the length of its extension, in the catheter position confirmation step 902, an appropriate amount of flushing fluid is injected into the nasal flushing catheter 3 under pressure. Confirming that the nasopharynx 52 has a jet of water indicates that the nasal flushing catheter 3 has entered the nasopharynx (shown in Figure 16), or confirming that a part of the side hole at the end of the catheter has entered the nasopharynx with an endoscope.
  • the nasal flushing catheter 3 is connected to the automatic injectors 2 and 4 for nasal flushing catheters, and the perfusion volume, perfusion rate, intermittent time and repetition times are set.
  • the nasal flushing catheter special auto-injector 2, 4 is used to perform multiple perfusion actions, and the nasal flushing catheter 3 is slowly withdrawn during the infusion process until the water column sprays on the nasal vestibule 51 Before exiting (shown in Figure 17), the entire path of the flushing nasal catheter 3 is completely cleaned.
  • step 905 the aforementioned step 901 of extending the nose catheter 3 into the nasopharynx 52 through other slit-like paths, the step of confirming the position of the catheter 902, the setting step 903, the perfusion and exit step 904 are repeated, and the same is performed Clean, when all the nasal passages (see Figure 1 in the upper nasal passage 11, upper adjacent septum space 12, middle adjacent septum space 13, lower adjacent septum space 14, the upper half of the vertical section of the middle nasal passage 15, middle The lower half of the vertical section of the nasal passage 16, the horizontal section of the middle nasal passage 17, the vertical section of the lower nasal passage 18 and the horizontal section of the lower nasal passage 19) are all cleaned, the mucus and nasal excrement in the nasal cavity must be removed, and the chronic sinuses will be restored In the earliest stage of inflammation, there is no nasal congestion and only newly discharged mucus. This is the carpet flushing method.
  • the embodiment of the present invention provides a special auto-injector for nasal flushing catheters and a carpet-style nasal flushing method.
  • the nasal flushing catheter 3 is collapsed to extend into the nasopharynx 52 through each path, and the auto-injector 2, 4 for nasal flushing catheters is connected instead.
  • Manually infuse the flushing fluid the catheter slowly withdraws, while exiting the catheter, while injecting the flushing fluid, spray multiple slender water columns to clean the mucus and nose of the path, each path 5 times, 10 times or 15 times or any other times.
  • This carpet-style nasal flushing method can indeed effectively solve the symptoms of severe nasal congestion in chronic sinusitis, returning to the state where there is no nasal congestion and only mucus continues to drain from the nasal cavity.
  • the patient can choose whether to remove the turbinate or to flush the nasal cavity frequently. Therefore, it has industrial applicability.

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Abstract

一种冲鼻导管(3)专用的自动注射器(2,4)及地毯式冲鼻法。自动注射器(4)包含一贮液筒、一动力单元(44)及一动力转换单元(45)。动力转换单元(45)可转换动力单元(44)的动力，可以精准控制灌注冲洗液的暂停时间及重复次数，以精确输送冲洗液产生每秒5cc～20cc的灌注速度。当冲鼻导管(3)经过鼻腔进入鼻咽(52)后连接自动注射器(2,4)后，可以一面冲洗一面慢慢退出冲鼻导管(3)，喷出垂直于冲鼻导管(3)的多重细长水柱，清除冲鼻导管(3)所经路径的粘液及鼻屎。如果鼻腔内所有的复杂空间都执行相同的清洗过程，则能够很快改善慢性鼻窦炎的鼻塞症状。

Description

冲鼻导管专用自动注射器及地毯式冲鼻法 技术领域
本发明公开一种自动注射器，尤其是一种冲鼻导管专用自动注射器，以及使用该冲鼻导管专用自动注射器的地毯式冲鼻法。
背景技术
自从2012年申请人即开始使用上市前的冲鼻导管喷出垂直于导管的多重细长水柱治疗自己的慢性鼻窦炎，包含改变边孔总面积及灌注速度以改变水柱强度，改变边孔的分布范围，以及可塌陷冲鼻导管的特殊设计。水柱平均高度与边孔总面积的平方成反比，与灌注速度的平方成正比，在每秒10cc灌注速度下，将导管区分为：1.可喷出平均垂直水柱高度90cm以上的高压导管；2.可喷出平均垂直水柱高度45cm～90cm的中压导管；3.可喷出平均垂直水柱高度30cm～45cm的低压导管。所有导管都需背压的累积才能产生平均强度的水柱，背压越大水柱越强，因此高压导管的管壁最厚，以注射筒连接压力计再连接冲鼻导管加压灌注测得最大3ATM～4.5ATM的最大压力；中压导管管壁较薄，测得2ATM～3.5ATM的最大压力；低压导管管壁最薄，测得1ATM～2.5ATM的最大压力。因导管管径很小，加压灌注中流速很快，会产生乱流(turbulence)导致能量及压力损失，因此压力读数不等于管腔实际压力。水柱垂直高度虽与管腔压力相关，但管腔压力影响边孔大小，边孔大小影响边孔阻力，边孔阻力影响水柱高度，因此水柱垂直高度与管腔压力并非成正比。可塌陷冲鼻导管具有扁平状封闭的末端，柔软的管壁在压力下可塌陷，因为扁平状封闭末端远比近端直径小，具有大导管大流量及容易操控的优点，也具有小导管进入小隙缝状空间的优点。各种方法都可以改善鼻塞症状，其中以可塌陷冲鼻导管最佳，但至多一个星期鼻塞仍会复发，仍需要冲鼻导管清洗。让病人无止尽地使用冲鼻导管并不是我们先前发明的目的，仍需找出更好的方法。
发明内容
有鉴于此，本发明的目的是在提供一种冲鼻导管专用自动注射器及一种地毯式冲鼻法。
本发明的一种冲鼻导管专用自动注射器，用以连接一具有封闭末端及多个边孔的冲鼻导管，灌注冲洗液从该多个边孔喷出多重细长水柱进行冲鼻治疗，并可设定重复灌注次数，该冲鼻导管专用自动注射器包含一冲洗液来源、一与该冲洗液来源连接的冲洗液输送装置，及一与该冲洗液输送装置连接的动力单元。
可选的，是在于上述的冲洗液输送装置是一个蠕动泵。
该蠕动泵包括一泵槽(pump casing)、一设置于该泵槽的弹性圆管、一设置于该泵槽的转轮(rotor)，及至少一设置于该转轮外围的滚轮(roller)。
该弹性圆管一端连接该冲洗液来源，另一端连接冲鼻导管。
该动力单元用以精准控制该蠕动泵的转速、转动周数、暂停时间及重复次数。
该蠕动泵用以精确定量、定速灌注冲洗液从该多个边孔喷出多重细长水柱进行冲鼻治疗。
可选的，是在于上述的冲洗液输送装置包括一三向连接器、一注射筒，及一动力转换单 元。
该三向连接器分别与该冲洗液来源、该注射筒，及该冲鼻导管连接。
该三向连接器与该冲洗液来源及该冲鼻导管连接之间分别设有一单向逆止阀。
该注射筒与该动力转换单元连接，该动力转换单元再与该动力单元连接。
该动力单元可以精准控制转速、转动周数、暂停时间及重复次数，该动力单元的圆周运动经由该动力转换单元转换为直线往复运动，以驱动该注射筒的推杆执行灌注及抽吸冲洗液的动作。
可选的，是在于上述的弹性圆管的弯曲模量不大于603MPa，外径与管壁厚度比不大于41.55。
可选的，是在于上述的弹性圆管的弯曲模量为不大于170MPa，外径与管壁厚度比不大于26.9。
可选的，是在于上述的弹性圆管的弯曲模量不大于12MPa，外径与管壁厚度比不大于11.11。
本发明另提供一种地毯式冲鼻法，适用于使用一具有封闭末端及多个边孔的冲鼻导管，及上述的冲鼻导管专用自动注射器。该地毯式冲鼻法包含一伸入步骤、一导管位置确认步骤、一设定步骤、一灌注及退出步骤。
于该伸入步骤中，将该冲鼻导管的封闭末端从鼻前庭经过隙缝状路径进入鼻咽。
于该导管位置确认步骤中，取适量冲洗液加压灌入该冲鼻导管以确认鼻咽有水柱喷出，或用内视镜确认导管末端的一部分边孔已进入鼻咽。
于该设定步骤中，将该冲鼻导管连接该冲鼻导管专用自动注射器，执行者在该冲鼻导管专用自动注射器上设定每次的灌注量、灌注速度、暂停时间及重复灌注次数。
于该灌注及退出步骤中，通过该冲鼻导管专用自动注射器执行多次灌注动作，并在灌注过程中慢慢将该冲鼻导管退出，直到水柱在鼻前庭喷出为止，用以完全清洗所经路径的粘液及鼻屎。
可选的，还包括重复步骤，用该冲鼻导管经过其他隙缝状路径进入鼻咽，再重复前述的导管位置确认步骤、设定步骤、灌注步骤及退出步骤，以完全清洗所经路径的粘液及鼻屎。
可选的，该冲鼻导管具有扁平状的封闭末端。
本发明的有益功效在于，该自动注射器可以完全取代执行者执行不限次数的灌注动作，快速清洗导管所经路径的粘液与鼻屎；该地毯式冲鼻法可以清洗所有的鼻腔空间，有效改善鼻塞症状，造福病人。
附图说明
图1是狭窄型慢性鼻窦炎病人鼻腔本体后1/3处的冠状截面图，说明鼻甲比鼻通道大的形态；
图2是一侧面剖视示意图，说明可塌陷冲鼻导管具有扁平状封闭末端的形态；
图3是一剖视示意图，说明该扁平状封闭末端直立放置的形态；
图4是一剖视示意图，说明该扁平状封闭末端水平放置的形态；
图5是一人体鼻腔侧面剖视图，说明一冲鼻导管以大角度在鼻前庭向上伸入的形态；及
图6是一人体鼻腔侧面剖视图，说明该冲鼻导管在大角度伸入鼻前庭后，弯曲该冲鼻导管体外的部分使该冲鼻导管前端以水平方向经过鼻腔上方空间进入鼻咽的形态；
图7是阻塞型慢性鼻窦炎病人鼻腔本体后方1/3处的冠状截面，说明粘液及鼻屎从上而下堆积，几乎完全阻塞只剩下方还有一些空隙的形态；
图8是一装置示意图，说明以一蠕动泵将冲洗液灌注于一冲鼻导管，以喷射多重细长水柱的形态；
图9是一装置示意图，说明一注射筒驱动器以连杆机构驱动该注射筒的推杆，抽吸冲洗液进入该注射筒的形态；
图10是一装置示意图，说明该注射筒驱动器以连杆机构驱动一注射筒的推杆，灌注冲洗液从冲鼻导管的边孔喷射多重细长水柱的形态；
图11是一装置示意图，说明一注射筒驱动器以一凸轮机构驱动该注射筒的推杆，抽吸冲洗液进入该注射筒的形态；
图12是一装置示意图，说明该注射筒驱动器以一凸轮机构驱动一注射筒的推杆，灌注冲洗液从冲鼻导管的边孔喷射多重细长水柱的形态；
图13是一装置示意图，说明一流体控制阀于第一位置，以控制流体进入一活塞模块的一第一空间，并使该活塞模块的一活塞推杆将该推杆拉出该注射筒；
图14是一装置示意图，说明该流体控制阀于第二位置，以控制流体进入该活塞模块的一第二空间，并使该活塞模块的该活塞推杆将该推杆推入该注射筒；
图15是一装置示意图，说明该流体控制阀于第三位置，并停止流体的流动以暂停该推杆的活动；
图16是一人体鼻腔侧面剖视图，说明一冲鼻导管在鼻咽喷射多重细长水柱的形态；及
图17是一人体鼻腔侧面剖视图，说明该冲鼻导管在鼻前庭喷射多重细长水柱的形态；
图18是本发明地毯式冲鼻法的流程图。
附图中的符号说明：
11上鼻通道；12上邻中膈空间；13中邻中膈空间；14下邻中膈空间；15中鼻通道垂直段上半段；16中鼻通道垂直段下半段；17中鼻通道水平段；18下鼻通道垂直段；19下鼻通道水平段；2冲鼻导管专用自动注射器；21冲洗液来源；22蠕动泵；221弹性圆管；222泵槽；223转轮；224滚轮；225入水口；226出水口；23动力单元；24单向逆止阀；3冲鼻导管；31边孔；4冲鼻导管专用自动注射器；41冲洗液来源；42三向连接器；43注射筒；431推杆；44动力单元；45动力转换单元；46注射筒驱动器；51鼻前庭；52鼻咽；6流体动力控制机构；61动力单元；62方向控制单元；621方向控制模块；622流体控制阀；63作用单元；631流体储存箱；632活塞模块；6321圆筒；6322活塞；6323活塞推杆；6324第一空间；6325第二空间；633回流管；634压力管；635泄压管；636泄压阀；637流体逆止阀；64流体；901伸入步骤；902导管位置确认步骤；903设定步骤；904灌注及退出步骤；905重复步骤。
具体实施方式
发明动机
经过漫长的试验，申请人终于找到一个使用可塌陷冲鼻导管的冲鼻方法，已超过两个月不需使用冲鼻导管，证明是最佳的方法，命名为地毯式冲鼻法。
慢性鼻窦炎依计算机断层影像可分为狭窄型及阻塞型两种类型。
请参阅图1，这是狭窄型鼻腔本体后方三分之一的冠状截面图，鼻腔是大约4cm～5cm高、3cm底的三角形，以三个板状的鼻甲隔成隙缝状的三个鼻通道及一个临中膈空间，其表面积远比管状结构辽阔，从鼻窦排出的粘液在此鼻腔表面形成薄层，再干化成薄层的鼻屎，反复进行，终于造成鼻甲巨大鼻通道狭窄的形态，而正常人则鼻甲比鼻通道小或相同。因为垂直水柱穿透力最强，只有导管直接抵达之处才有垂直于两侧的水柱，随着与导管距离的增加，垂直于两侧的垂直向量及穿透力都会急速降低，因此导管必需分别以水平方向经过上鼻通道11、上邻中膈空间12、中邻中膈空间13、下邻中膈空间14、中鼻通道垂直段上半段15、中鼻通道垂直段下半段16、中鼻通道水平段17、下鼻通道垂直段18及下鼻通道水平段19等九个进入鼻咽的路径才能涵盖所有鼻腔表面，得到最佳的冲洗效果，这就是地毯式冲鼻法。
图2、图3、图4，其为一种可塌陷冲鼻导管。其中，图2说明该可塌陷冲鼻导管具有扁平状封闭末端的形态，图3及图4是该扁平状封闭末端直立放置及水平放置的形态。因为扁平状封闭末端远比近端直径小，柔软的管壁在压力下可塌陷，可塌陷冲鼻导管具有大导管大流量及容易操控的优点，也具有小导管进入小隙缝状空间的优点，因此容易经过以上所述九个狭窄隙缝状路径进入鼻咽。扁平状封闭末端，如直立放置可顺形经过左右狭窄的隙缝状空间，如上邻中膈空间12、中邻中膈空间13、下邻中膈空间14、中鼻通道垂直段上半段15、中鼻通道垂直段下半段16及下鼻通道垂直段18；如水平放置则可顺形经过上下狭窄的隙缝状空间，如中鼻通道水平段17及下鼻通道水平段19。
请参阅图5、图6鼻腔侧面剖视图，要经过上邻中膈空间12、上鼻通道11或中鼻通道垂直段上半段15等鼻腔上方空间进入鼻咽，不能直接以直线方向伸入，小角度则高度不足，向上角度太大，则因鼻腔都是上狭下宽的隙缝状况空间，很容易卡在狭窄空间，当从外推送导管，导管无法前进只会在鼻腔内弯曲，无法进入鼻咽。又因导管非常柔软不会引起疼痛，执行者无法认知导管在鼻腔内弯曲，此时虽也可执行冲鼻治疗，但会遗漏很多鼻腔表面，这是几年来鼻塞改善未如预期容易复发的原因，也因此对冲鼻导管的疗效半信半疑，但经过地毯式冲鼻法成功的经验，申请人确信慢性鼻窦炎的鼻塞只有一个单纯的疾病机转(pathophysiology，或称病理生理学)：即粘液与鼻屎互变及在鼻腔累积的物理性质，任何治疗都应依据此疾病机转。
实际操作时，如要经过上邻中膈空间12、中邻中膈空间13、下邻中膈空间14，上鼻通道11，可将导管扁平状封闭末端直立放置紧靠鼻中膈伸入，其中，下邻中膈空间14直接以水平方向伸入，中邻中膈空间13稍向上约2cm后直接伸入，进入鼻咽52；如要经过上邻中膈空间12，向上约3cm后将在鼻前庭外的导管弯曲再慢慢推入，则弧形的导管可以引导最前端成为水平方向继续伸入鼻咽52，在此伸入过程中扁平状封闭末端向外转则可经过上鼻通道11伸入 鼻咽52；如要经过下鼻通道水平段19只需将导管紧靠鼻腔底部稍向外，水平放置扁平状封闭末端直接伸入即可进入鼻咽52；如要经过下鼻通道垂直段18，导管更向外紧靠鼻腔底部，直立放置扁平状封闭末端伸入即可进入鼻咽52；如要经过中鼻通道水平段17则在鼻前庭向上约1.5cm稍向外再水平放置扁平状封闭末端直接伸入即可进入鼻咽52，水平段没有卡在狭窄的空间的问题；如要经过中鼻通道垂直段下半段16，需直立放置扁平状封闭末端向上向外1.5cm后，再将在鼻前庭外的导管弯曲再慢慢推入可进入鼻咽52；要经过中鼻通道垂直段上半段15，以直立放置扁平状封闭末端向上向外2.5cm后，再将在鼻前庭外的导管弯曲再慢慢推入，就可以水平路径进入鼻咽52。总之，冲鼻导管要分别经过以上所有空间进入鼻咽，而不是只进入这些空间，这是地毯式冲鼻法成功的秘密。
导管从以上所述路径进入鼻咽后，开始用10cc注射筒用力灌注，从边孔喷出的多重细长水柱清洗，清洗中慢慢退出导管至水柱可以在鼻前庭喷出为止。每个路径如以注射筒灌注十次以上，可以保证不遗漏任何地方，包含三个鼻甲的最后端，这是鼻塞改善后最需要清洗的地方，因为卧姿中粘液会移动到鼻甲最后端，而睡眠占三分之一的时间，因此容易造成粘液及鼻屎的堆积，即使其他地方已经畅通，只要鼻甲最后端仍有阻塞，鼻塞仍然存在。这正是地毯式冲鼻法优于其他方法的原因。所有路径完全地毯式清洗需重复抽吸180次灌注180次，非常熟练的人也要耗时30分钟以上。虽然灌注10次可以涵盖一个路径，但所需灌注次数依鼻屎厚度而定，厚度越厚所需灌注次数越多，严重的病人鼻屎很厚，每个路径需要不只10次，可能需要20次，甚至30次灌注，对病人而言，在时间和精力上是很大的负担，难以坚持到底，很容易回复到严重的症状，无法认知地毯式冲鼻法的优点，因此，能重复此抽吸及灌注动作的自动注射器显然有必要。
另外，有很多严重慢性鼻窦炎病人是阻塞型，请参阅图7，这是阻塞型鼻腔本体后方三分之一的冠状截面，说明粘液及鼻屎从上而下几乎完全阻塞，只剩下鼻通道水平段19还有空隙的情况。这种类型只能从下方空隙放置冲鼻导管进入鼻咽，先清洗鼻腔下方的粘液及鼻屎，逐渐扩大呼吸通路，再从打通的呼吸通路放置冲鼻导管清洗更上方的粘液和鼻屎。此阻塞型与狭窄型不同，无法一次清洗所有鼻腔空间。阻塞型慢性鼻窦炎鼻腔下方残留的空气通路并不一定是隙缝状，不一定需要扁平状封闭末端的可塌陷冲鼻导管，也可以使用圆形末端的冲鼻导管。阻塞型慢性鼻窦炎比狭窄型慢性鼻窦炎有更多的粘液及鼻屎，需要更多次的灌注次数及疗程次数，更需要自动注射器取代人力。还有一部分病人介于两种类型之间，需仔细评估。总的以冲鼻导管做冲鼻治疗前都需执行计算机断层扫摄影，由医师仔细评估，拟定最佳的治疗计划。
地毯式冲鼻法可以恢复到慢性鼻窦炎没有鼻塞的最原始状况，在此情况可以免除麻烦的导管冲鼻治疗，可以正常睡觉，但因鼻窦不停产生粘液，清醒时仍需频繁用徒手洗鼻法清洗从鼻窦新排入鼻腔的粘液，以避免粘液再度干化成鼻屎。鼻屎累积到一定厚度，如徒手冲鼻法无效就需再进行地毯式冲鼻法。
徒手洗鼻法是不用任何工具很容易学习的洗鼻法，以一手做杯盛冲洗液，盖住一边鼻孔，另一手压住另一边鼻孔，头部尽量朝下，再用力吸气将手杯的冲洗液，从鼻腔吸入鼻咽后再 用力排出，练习几次就会很熟练。头部朝下，冲洗液从鼻腔顶部进入鼻咽，空气则从鼻腔下部吸入鼻咽再进入气管，因此不影响呼吸。
为何清醒时需要频繁冲洗，而睡觉中不需要，因为鼻腔的隙缝状空间上狭下宽，鼻窦产生粘液从最上面开口排出，清醒时多为立姿，粘液顺着重力向下到较宽处会变成薄层，容易受呼吸空气干化变成更薄的鼻屎，累积到一定厚度的鼻屎远比粘液困难清洗，因此需要在尚未变成鼻屎尚未变厚前频繁清洗。相反地，睡觉多为卧姿，粘液只会前后移动，不会向下移动，因为相同高度的隙缝状空间的宽度相同，粘液不会变成薄层而保持水珠的形状，与空气接触面积远比薄层小，甚至完全阻塞空气的流通，因此不易干化，等睡醒再清洗即可。
如前所述，鼻腔本体的冠状截面是大约3cm底、4～5cm高的三角形，其容积等于截面积乘以前后长度(即5cm)，一侧的容积等于3*5*5/2＝37.5cm 3。慢性鼻窦炎鼻塞严重的病人鼻甲加粘液所占体积都很大、鼻通道都很小，但经冲鼻导管治疗后没有鼻塞时鼻甲的软组织与鼻通道的空气空间约相等，一侧的空气空间容积大约各为37.5cm 3/2＝18-19cm 3，因此徒手冲鼻法的手杯需15ml以上的冲洗液才够吸到鼻咽，否则冲洗液只到鼻腔，即使用力也只吸空气到鼻咽，因而冲洗效果减弱。因为手杯的冲洗液不超过25cc，而且头朝下，而气管上方会咽软骨以上的口咽及鼻咽是大约3cm*3cm*7cm的管状结构，其63cc容积远大于25cc，冲洗液只到鼻咽，不会造成呛水现象。
徒手洗鼻法虽很容易学习，但只适用于鼻腔畅通的病人，因为只有鼻腔畅通，没有相当厚度的鼻屎的情况下，冲洗液才能顺利通过隙缝状空间进入鼻咽清洗鼻甲最后端的粘液。虽然需频繁清洗鼻腔，但不用切除鼻甲，鼻腔结构可以保留，这应该是医学界所能想象严重鼻窦炎的最佳结果。
传统的冲鼻治疗是病人自己终身执行的居家治疗，冲鼻导管是为改善传统冲鼻器的疗效的设计，因此也需要病人自己终身执行。而病人学习使用冲鼻导管并非容易，如果地毯式冲鼻法可在短期内改善症状，执行者可以改为医师，医师很快学会操作技术。但治疗众多病人所需的重复抽吸及用力灌注动作仍是很大的负担，如果有自动注射器，就可取代这耗时耗力的工作。每个路径的灌注次数可以再增加，冲洗次数越多效果越佳，地毯式冲鼻法的疗程次数有可能缩短至合理的范围，变成医师执行取代开刀的标准治疗，这对病人是一大福音。
为了尽快造福病人，申请人搜寻市售电动洗鼻器，首先找到NeilMed公司的格罗桑水脉冲鼻窦冲洗系统(Grossan Hydro Pulse Nasal and Sinus Irrigation System，具体可通过以下网址查看：http://www.hydromedonline.com/wp-content/uploads/2015/03/HydroPulse-User-Manual.pdf)，此洗鼻器有一个喷嘴(nozzle)，其说明书第一页清楚记载，水柱需调整至一英寸高度，第五页在回答鼻塞时可不可以增加压力时，回答是不可，因水力脉冲(Hydro Pulse)是柔和的，而且设计只在低压下作用，超过建议的压力会导致伤害。也找到另一个电动洗鼻器：纳瓦奇鼻护理(Navage Nasal Care，具体可通过以下网址查看：https://www.navage.com/v/navage-owners-manual-2017.pdf)，其说明书第七页画底线处强调是全世界唯一柔和动力抽吸的洗鼻器。此电动洗鼻器有上下两个贮液筒连接到两个具有鼻枕头(nose pillow)的水口，两个鼻枕头可塞住鼻孔，避免冲洗液外流，其一边为被动吸入口，另 一边为主动吸出口。主动吸出口以电动吸力抽吸一边鼻孔产生负压，传到另一边鼻孔产生柔和的抽吸力(gentle power suction)在被动吸入口抽吸上贮液筒内的冲洗液，此冲洗液流入鼻腔再从鼻咽经另一边鼻腔主动吸出口流入下贮液筒。
这两个电动洗鼻器都强调低压，其他应该也是如此，因为所有的医疗器材都跟据医学专家的观念制造，请参考：鼻腔盐水治疗慢性鼻腔症状的随机对照试验(Nasal Saline for Chronic Sinonasal Symptoms A Randomized Controlled Trial，具体可通过以下网址查看：https://jamanetwork.com/journals/jamaotolaryngology/article-abstract/484888)及鼻腔冲洗：从经验主义到循证医学(Nasal irrigation：From empiricism to evidence-based medicine.A review.，具体可通过以下网址查看：https://www.sciencedirect.com/science/article/pii/S1879729615001003)这两篇2007及2015的医学论文摘要处都强调大量低压洗鼻是最好的方法，此观念和申请人小量高压相反。因为冲鼻导管必需具有背压(back pressure)的累积才能从多数边孔喷出近乎平均强度的多重细长水柱，才能保证冲洗效果，背压是边孔总面积小于内腔截面积致使管腔流入量大于边孔流出量所致。如前所述，即使是低压冲鼻导管(边孔总面积大、水柱30cm～45cm垂直高度)也可以产生1-2.5ATM的压力。市售电动洗鼻器只能产生轻柔低压水流，水柱高度只能设定为2.5cm(约1英寸)高度与申请人的低压水柱30cm～45cm都有巨大的差别，更遑论90cm以上的高压水柱，显然不符申请人的目的，其设计理念排除高压水柱，也属反向教示，因此申请人只能自己设计。
本发明一种冲鼻导管专用自动注射器可分为蠕动泵型及注射筒型两型。
(1)蠕动泵型的冲鼻导管专用自动注射器2。
参阅图8，蠕动泵型的冲鼻导管专用自动注射器2，具有一个冲洗液来源21，可以是贮液筒或医用生理盐水包装。一个蠕动泵(peristaltic pump)22及一个可以精准控制转速及转动角度的动力单元23(例如马达)。该蠕动泵22具有一泵槽222(pump casing)、一支弹性圆管221，及一个转轮223(rotor)。该转轮223设置有至少一个滚轮224(roller)，该动力单元23可以转动该转轮223。该弹性圆管221的一端为一入水口225，该入水口225可以连接该冲洗液来源21，该弹性圆管221另一端可连接一出水口226，该出水口226可以连接一单向逆止阀24(check valve)，该出水口226更可以连接一个鲁尔接头后，再用一个延长管连接该冲鼻导管3。该动力单元23在低转速时即具有大的扭力，可以带动该蠕动泵22推动冲洗液产生每秒5cc～20cc的灌注速度。当该动力单元23驱动该转轮223顺时钟转动时，该滚轮224自该入水口225向该出水口226滚动，以挤压该弹性圆管221内的冲洗液向出水口226流出，此时该滚轮224后方的弹性圆管221因自身弹性而自动扩张恢复原状，产生负压并吸引该冲洗液来源21中的冲洗液再度充满该弹性圆管221，同时该出水口226的单向逆止阀24因该弹性圆管221的内负压而关闭，可以防止该出水口226外的流体逆流。其中，蠕动泵型冲鼻导管专用自动注射器可分为间歇供输型(未示出)及连续供输型。
间歇供输型的蠕动泵22具有一个半圆的弹性圆管221、一个转轮223及一个滚轮224。为避免产生呛水的现象，每次灌注量较佳为10cc，又因该动力单元23每转一圈只有半圈可以压迫该弹性圆管221，因此该泵槽222内的弹性圆管221的容积较佳为10cc。假设该动力单元23 以每分钟15圈的转速驱动该蠕动泵22，连续转动10圈需40秒，则该动力单元23驱动该蠕动泵每转一圈需4秒，半圈需2秒，则该冲鼻导管专用自动注射器2以5cc/秒的速度供输冲洗液10cc，再休息2秒，如此可以间歇灌注10次需40秒；假设该动力单元23以每分钟30圈的转速驱动该蠕动泵22，连续转动10圈需20秒，则该动力单元23驱动该蠕动泵22每转一圈需2秒，半圈需1秒，则该冲鼻导管专用自动注射器2以10cc/秒的速度供输冲洗液10cc，再休息1秒，如此间歇灌注10次需20秒；假设该动力单元23以每分钟45圈的转速转动该蠕动泵22，连续转动10圈需13.3秒，则该动力单元23驱动该蠕动泵22每转一圈需1.33秒，半圈需0.66秒，则该冲鼻导管专用自动注射器2以15cc/秒的速度供输冲洗液10cc，再休息0.66秒，如此间歇灌注10次需时13.3秒；假设该动力单元23以每分钟60圈的转速驱动该蠕动泵22，连续转动10圈需10秒，则驱动该蠕动泵22每转一圈需1秒，半圈需0.5秒，则注射器以20cc/秒的速度供输冲洗液10cc，再休息0.5秒，如此间歇灌注10次需10秒。
连续供输型具有多个滚轮224及一个或多个转轮223，该动力单元23转动该蠕动泵22时为连续出水，该蠕动泵22每转一圈弹性圆管221两次出水，该动力单元23的连续转动周数可以控制出水量，因此弹性圆管221的容积不一定为10cc，而可以为任何数值。假设该蠕动泵22内半圆的弹性圆管221容积为5cc，而该动力单元23以每分钟30圈的转速驱动该蠕动泵22，则该动力单元23转动该蠕动泵22每2秒转1圈，则该冲鼻导管专用自动注射器2以5cc/秒的速度供输冲洗液10cc；假设该动力单元23以每分钟60圈的转速转动该蠕动泵22，该蠕动泵22每1秒转1圈，则该冲鼻导管专用自动注射器2以10cc/秒的速度供输冲洗液10cc；假设该动力单元23以每分钟90圈的转速转动该蠕动泵22，该蠕动泵22每0.66秒转1圈，则该冲鼻导管专用自动注射器2以15cc/秒的速度供输冲洗液10cc；假设该动力单元23以转速每分钟120圈的转速转动该蠕动泵22，该蠕动泵22每1秒转2圈，则该冲鼻导管专用自动注射器2以20cc/秒的速度供输冲洗液10cc。因为可以精确控制该动力单元23的转动，供输冲洗液后可以设定任何暂停时间，并依此重复灌注及暂停的循环。上述两类蠕动泵型冲鼻导管专用自动注射器2都可以程序设定，一个进程较佳为间歇灌注5次～15次，执行者(病人或医师)可以自由选择。
间歇供输型滚轮224滚过后，弹性圆管221马上恢复原状，冲洗液几乎跟随滚轮224之后马上塡充弹性圆管221，即使没有单向逆止阀24，冲鼻导管3的内容物逆流进入弹性圆管221的机会很少；连续供输型当第一个滚轮224滚到出水端时，第二个滚轮224也已到进水端压迫弹性圆管221产生向出水端的正压，即使没有单向逆止阀24，也不会有负压吸引冲鼻导管3的内容物逆流进入弹性导管；而且本注射器用于冲洗鼻腔而非用于血管，少量空气进入弹性圆管221不需完全禁止，因此弹性圆管221与冲鼻导管3之间的单向逆止阀24并非不可或缺。
以上两类型蠕动泵型冲鼻导管专用自动注射器2中，该泵槽222内的弹性圆管221虽以半圆为举例，但实际实施时并不限于半圆，可以是小于全圆的任何形状，只要该弹性圆管221可以排列成平滑的形状，不影响该滚轮224的平顺滚动即可，而间歇灌注可以由该动力单元23的转动及暂停来达成。两种类型都可依以上计算方式，可选用不同容积的弹性圆管221，搭配改变该动力单元23的转动速度，来找到最佳的方案。
该冲洗液来源21可以是温开水或生理盐水，其容量可以为任何数値，较佳为1000cc～ 2000cc。
该蠕动泵22的缺点及其改善方法：
一般的蠕动泵22虽有精确定量、定速及精确重复灌注的优点，但其弹性圆管221不能在高压环境下使用。其原因是该弹性圆管221在高压下会膨胀，当冲洗液堆积在该弹性圆管221内时，会造成灌注速度及灌注量不足的现象，解决的方法是使用膨胀率可接受的弹性圆管221。
请参考弯曲模量的维基百科(可通过如下网址访问：https://en.wikipedia.org/wiki/Flexural_modulus)。弯曲模量公式Ebend＝L3F/4wh3d中的Ebend是指在一材料弯曲变形，或在一个长方形梁的三点测试中所得到的应力与应变的比值。公式中w为宽度，h为高度，L是外侧两个支持点之间的距离，d是因为在中间受力F而产生的形变。圆管受灌注压力膨胀可视为此公式的变异，长度(L)可视为圆管的直径(外径或内径)；应力(F)可视为圆管内压力；宽度(w)可视为圆管长度；高度(h)可视为管壁厚度；d可视为圆管半径的膨胀量(延长量)直径的膨胀量则为2d。依此公式弯曲模量Ebend与外径管壁厚度比的三次方(L/h) 3成正比。
圆管长度w(只有泵内及出水端部分才受压力的影响，入水端的部分不受影响)与膨胀量(d)成反比，而圆管长度与管腔容积成正比，两因素互相抵消，因此圆管长度不影响容积膨胀比率，可以不计。例如10mm外径、8.4mm内径、长度10cm的圆管，其原始容积为0.84*0.84*0.785*10＝5.53896cc，假设受压膨胀变形d为0.2mm，则内径变成8.8mm膨胀后的管腔容积为0.88*0.88*0.785*10＝6.07904cc，容积增加为6.07904-5.53896＝0.54cc；假设相同圆管长度增加2倍(20cm)，则其膨胀量d减半成为0.1mm，膨胀前管腔容积为5.53896cc*2＝11.07792cc，膨胀后管腔容积为8.6*8.6*0.785*20＝11.61172cc，容积增加为0.53380cc，略小于原长度的容积增加11.61172-11.07792＝0.54cc；假设相同圆管长度增加4倍(40cm)，则其弯曲量减为0.05mm，膨胀前管腔容积为5.53896cc*4＝22.15584cc，膨胀后管腔容积为8.5*8.5*0.785*40＝22.6865cc，容积增加为22.6865-22.15584＝0.53066cc，略小于原长度的容积增加0.54cc，也略小于20cm长度圆管容积的增加量0.53380cc。以上可以证明圆管长度的增减不影响圆管容积膨胀量，可以不考虑。因此弹性圆管221的容积膨胀率完全取决于外径管壁厚度比。
实施例一：相同材质弹性圆管的外径与管壁厚度的计算。
弯曲模量(Flexural modulus)的公式为Ebend＝L3F/4wh3d，或dw＝L3F/4h3Ebend。因为相同材质弯曲模量公式的Ebend也相同；弹性圆管221连接到冲鼻导管3，两者压力(F)相同可不计；因此管壁厚度与圆管外径比相同的圆管，其容积膨胀量(dw)，弯曲量与圆管长度的乘积也相同。
因为地毯式冲鼻法不再依靠强劲水柱，而依靠导管以水平方向伸入狭窄的空间，再用垂直水柱直接冲洗鼻腔空气通路两侧粘液及鼻屎，因此只要低压水柱即可。高压冲鼻导管3的累积背压最大，膨胀率也最大；低压冲鼻导管3的累积背压最小，膨胀率也最小；为了计算该弹性导管221符合需求的最低条件，即最大的外径与管壁厚度比或最小管壁厚度与外径比，申请人用弯曲模量12MPa的PEBAX-2533(polyether block amide-2533，其中polyether block  amide是热塑性弹性体的一种，包含一系列族群，如PEBAX-2533、PEBAX-3533、PEBAX-4533、PEBAX-5533、PEBAX7033、PEBAX-7433等，并不以此为限)制造外径2mm、管壁厚度0.18mm的低压导管做水柱垂直高度、管内压力及导管膨胀的测试。以注射筒连接压力计灌注此低压导管在1ATM时，测得喷出的多重细长水柱垂直高度约为30cm，因此该冲鼻导管3在1ATM以上的压力即符合冲洗需求。因为喷射中的多重细长水柱会造成导管的弹跳干扰导管外径的测量，因此用相同尺寸没有边孔的导管，连接压力计灌注空气至1ATM时，测得导管外径为2.10mm。
外径2mm、管壁厚度0.18mm、内径1.64mm的低压冲鼻导管3(外径管壁厚度比11.11)，其静止时管腔截面积为1.64*1.64*0.785＝2.11336mm 2，外缘截面积为2*2*0.785＝3.14mm 2，其管壁截面积等于外缘截面积减管腔截面积3.14-2.11336＝1.02664mm 2。如上所述，加压至1ATM时外径膨胀为2.10mm，其截面积为2.10*2.10*0.785＝3.46185mm 2，因管壁截面积不变，膨胀后的内腔截面积等于3.46185-1.02664＝2.43521mm 2，内腔面积膨胀率等于2.43521/2.11336＝1.152。而膨胀后内径等于截面积除以0.785的平方根等于1.76mm，内径延长(2d)＝1.76-1.64＝0.12mm。假设弹性圆管221外径10mm、内径8.2mm、管壁厚度0.9mm(外径管壁厚度比L/h＝11.11)，其静止内腔截面积等于8.2*8.2*0.785＝52.7834mm 2。因与该冲鼻导管3具有相同的外径管壁厚度比，在加压至1ATM时，其内径同样延长0.12mm成为8.32mm，其管腔截面积等于8.32*8.32*0.785＝54.3396mm 2，膨胀率等于54.3396/52.7834＝1.0295，2.95％的膨胀率只产生6％水柱强度的减弱，至少可喷出28cm的多重细长水柱，不影响冲洗效果，是可接受的数据，仍符合冲鼻治疗所需。因此以弯曲模量(flexural modulus)为12MPa的PEBAX-2533做成的弹性圆管221如外径管壁厚度比小于10/0.9＝11.11，即符合冲鼻导管3的灌注目的。
实施例二：在1ATM条件下，不同弯曲模量的外径管壁厚度比(L/h)的计算。
1.由弯曲模量的公式Ebend＝L3F/4wh3d，可知当弹性圆管221内压力(F)与变形量(d)相同时，弯曲模量(Ebend)与外径管壁厚度比(L/h)的立方成正比。PEBAX-3533的弯曲模量21MPa是PEBAX-2533的弯曲模量12MPa的21/12＝1.75倍，1.75的立方根为1.2。所以在1ATM条件下，弯曲模量21MPa、PEBAX 3533制造的弹性圆管221的(L/h)等于PEBAX 2533的1.2倍，为不大于11.11*1.2＝13.33。
2.同样地，PEBAX-4533的弯曲模量86MPa是PEBAX-2533的86/12＝7.167倍，其立方根约为1.93，因此该弹性圆管221的(L/h)为不大于11.11*1.93＝21.44。
3.同样地，PEBAX-5533的弯曲模量170MPa是PEBAX-2533的170/12＝14.17倍，其立方根约为2.421，因此该弹性圆管221的(L/h)为不大于11.11*2.421＝26.9。
4.同样地，PEBAX-7033的弯曲模量390MPa是PEBAX-2533的390/12＝32.5倍，其立方根约为3.2，因此该弹性圆管221的(L/h)为不大于11.11*3.2＝35.55。
5.同样地，PEBAX-7433的弯曲模量630MPa是PEBAX-2533的630/12＝52.5倍，其立方根约为3.74，因此该弹性圆管221的(L/h)为不大于11.11*3.74＝41.55。
实施例三：不同弹性圆管221内压力(F)所需的外径厚度比(L/h)。
1.依弯曲模量的公式Ebend＝L3F/4wh3d，当弯曲模量(Ebend)与膨胀量(d)相同时，弹 性圆管221内压力(F)与外径厚度比(L/h)的立方成反比。2ATM是1ATM的2倍，2的立方根约为1.262。因此，在2ATM条件下，弹性圆管221所需的(L/h)比在1ATM时小1.262倍，在PEBAX-2533等于11.11/1.262＝8.8；在PEBAX-3533(等于13.33/1.262＝10.56；在PEBAX-4533等于21.44/1.262＝16.99；在PEBAX-5533等于26.9/1.262＝21.31；在PEBAX-7033等于35.55/1.262＝28.17；在PEBAX-7433等于41.55/1.262＝32.93。
2.同样地，3ATM是1ATM的3倍，3的立方根约为1.442，弹性圆管221所需的(L/h)在3ATM条件下，比在1ATM时小1.442倍。因此，在PEBAX-2533等于11.11/1.442＝7.705；在PEBAX-3533等于13.33/1.442＝9.244；在PEBAX-4533等于21.44/1.442＝14.87；在PEBAX-5533等于26.9/1.442＝18.65；在PEBAX-7033等于35.55/1.442＝24.65；在PEBAX-7433等于41.55/1.442＝28.81。
3.同样地，4ATM是1ATM的4倍，4的立方根约为1.587，弹性圆管221所需的(L/h)在4ATM条件下，比在1ATM时小1.587倍。因此，在PEBAX-2533等于11.11/1.587＝7；在PEBAX-3533等于13.33/1.587＝8.4；在PEBAX-4533等于21.44/1.587＝13.51；在PEBAX-5533等于26.9/1.587＝16.95；在PEBAX-7033等于35.55/1.587＝22.4；在PEBAX-7433等于41.55/1.587＝26.18。
(2)注射筒型的冲鼻导管专用自动注射器4：
参阅图9、图10、图11、图12，注射筒型的冲鼻导管专用自动注射器4也可以精确定量、定速灌注冲洗液，产生每秒5cc～20cc的灌注速度，该冲鼻导管专用自动注射器4包含一个冲洗液来源41、一个三向连接器42、一个注射筒43、及一个注射筒驱动器46；该注射筒驱动器46包含一个动力单元(power unit)44及一个动力转换单元(power converting unit)45；该动力单元44为马达用以驱动该动力转换单元45；该三向连接器42与该冲洗液来源41之间设有一有单向逆止阀24，该三向连接器42与该冲鼻导管3之间设有一单向逆止阀24，该三向连接器42的另一向连接到该注射筒43。实际实施时，因为该冲鼻导管3上的多个边孔31的孔径都非常小，该注射筒43抽吸冲洗液时，该冲鼻导管3的管壁会塌陷封闭，该冲鼻导管3抽吸到的空气量很少，所以该冲鼻导管3与该三向连接器42之间可以不用设置该单向逆止阀24，不应以此为限。
动力转换单元45可将该动力单元44的圆周运动转换为直线往复运动，以驱动该注射筒43的推杆431执行灌注及抽吸冲洗液的动作。该动力转换单元45可以是连杆机构(图9、图10)、凸轮机构(图11、图12)。
当该动力转换单元45以直线运动拉回该注射筒43的推杆431时，因该射筒43内的负压，连接到该冲鼻导管3的连接器的单向逆止阀24关闭，避免抽吸空气进入该注射筒43中；接到该冲洗液来源41的连接器的单向逆止阀24打开，并抽吸冲洗液进入该注射筒43中(显示于图9、图11)。当该动力转换单元45以直线往复运动驱动注射筒43的推杆431向前推动时，连接到冲洗液来源41的连接器的单向逆止阀24关闭，连接到该冲鼻导管3的连接器的单向逆止阀24打开，因此冲洗液流向该冲鼻导管3中，并从边孔31喷出多重细长水柱(显示于图10、图12)。
因为该注射筒43的刚性，不会有上述弹性圆管221膨胀的问题。该动力单元44低转速时 具有大扭力可以精准控制转速、转动周数、暂停时间及重复次数，可达到定量定速灌注冲洗液及重复次数的目的。
参阅图13、图14、图15，此注射筒型的冲鼻导管专用自动注射器4也可以精确定量、定速灌注冲洗液，产生每秒5cc～20cc的灌注速度，包含一个冲洗液来源41、一个三向连接器42、一个注射筒43、及一个流体动力控制机构(fluid power control system)6，该流体动力控制机构具有一个动力单元(power unit)61、一个方向控制单元(directional control unit)62及一个作用单元(actuation unit)63。于本实施例，流体64为液体，该动力单元61可为一具有水泵的马达，或其他动力设施，不以此为限。该方向控制单元(directional control unit)62具有一个方向控制模块621及一个三位四通的流体控制阀622，该方向控制模块621可以控制该流体控制阀622的开、关及暂停的时间。该方向控制单元62可以精确控制该三位四通的流体控制阀622的阀门开关、时间及大小，以达到精确控制流体64的流速及流量的目的。
该作用单元63具有一个储存流体64的流体储存箱(tank)631及一个活塞模块632。该活塞模块632有一个圆筒(cylinder)6321，其内有一个活塞(piston)6322及连接该活塞6322并突出该圆筒6321外的活塞推杆(rod)6323，该圆筒6321内的空间被该活塞6322分隔为一第一空间(first space)6324及一第二空间(second space)6325，并分别以一回流管(return line)633及一压力管(pressure line)634连接该流体储存箱631。该活塞推杆6323用以连接该注射筒43的推杆431并以直线往复运动执行抽吸及灌注冲洗液的动作。在该流体储存箱631与动力单元61中间有一个泄压管635及一个泄压阀636，当压力超过设定值时会自动泄压。在流体储存箱631与流体控制阀622中间有一个流体逆止阀637避免流体64逆流。
参阅图13，当该方向控制模块621控制该流体控制阀622于第一位置时，流体64从该三位四通的流体控制阀622的阀门经该压力管634进入该第一空间6324，推动该活塞6322及该活塞推杆6323向后直线运动以带动该注射筒43执行从冲洗液贮存筒抽吸冲洗液的动作，此时连接到该冲鼻导管3的连接器的单向逆止阀24关闭，避免抽吸空气进入该注射筒43中,与此同时，该第二空间6325中的流体64经该回流管633回流进入该流体储存箱631。
参阅图14，当该方向控制模块621控制该流体控制阀622于第二位置时，流体64从该三位四通的流体控制阀622的阀门经该压力管634进入该第二空间6325以推动该活塞6322及该活塞推杆6323向前直线运动，此时，连接到该冲鼻导管3的连接器的单向逆止阀24打开，该注射筒43执行灌注冲洗液的动作，连接到该冲洗液来源41的三向连接器42的单向逆止阀24关闭，避免冲洗液逆流入该冲洗液来源41，与此同时该第一空间6324内的流体64经该回流管633回流进入该流体储存箱631内。
参阅图15，当该方向控制模块621控制该流体控制阀622于第三位置时，该压力管634及该回流管633中的流体64停止流动，该第一空间6324及该第二空间6325不会在进出流体64，因此该活塞推杆6323停止运动，该注射筒43也停止抽吸或注射冲洗液，该方向控制模块621可控制暂停时间。
该动力单元61的压力减去流体路线的阻力、活塞运动的阻力、注射筒的阻力及冲洗导管 的背压等于整个流体动力控制机制的净压力，此净压力可决定流体64的流速，此流速又可决定活塞推杆的位移速度及注射筒的灌注速度；流体64的流速乘以阀门开放时间等于流体64的流量，此流量又可决定该活塞推杆6323的位移量及该注射筒43的灌注量。如此流体动力控制机构6可经由该动力单元61，推动流体64经由该方向控制单元62进入该作用单元63，驱动该活塞模块632的活塞推杆6323进行直线往复运动以带动该注射筒43执行抽吸及注射冲洗液的动作，并可定量定速灌注冲洗液，也可以设定暂停时间及重复次数达到自动冲洗的目的。
在图13、图14、图15中，该三向连接器42与该冲洗液来源41之间同样设有一有单向逆止阀24，该三向连接器42与该冲鼻导管3之间设有一单向逆止阀24，该三向连接器42的另一向连接到该注射筒43。实际实施时，因为该冲鼻导管3上的多个边孔31的孔径都非常小，该注射筒43抽吸冲洗液时，该冲鼻导管3会塌陷，所抽吸到的空气量很少，连接到导管的三向连接器42不一定要有该单向逆止阀24。
其中，所述流体动力控制机构6是一种控制流体64流动方向的技术，于该实施例，所述流体64为液体，实际实施时，所述流体64也可以是气体，且该动力单元61可以是一种具有气泵的马达，但不应以此为限。
该冲洗液可以是温开水或生理盐水，其容量可以为任何数値，较佳为1000cc～2000cc。
地毯式冲鼻法：
回顾图1、图5、图6，并请参阅图16、图17，及图18，为一种地毯式冲鼻法，该地毯式冲鼻法包含一伸入步骤901、一导管位置确认步骤902、一设定步骤903、一灌注及退出步骤904、以及一重复步骤905。
图16，及图17示意鼻腔由上鼻甲F、中鼻甲G及下鼻甲H隔成多个狭窄空间，该地毯式冲鼻法使用一支材质柔软具有封闭末端及多个边孔的冲鼻导管3，较佳是可塌陷冲鼻导管3，并利用冲鼻导管专用自动注射器2、4于鼻腔中喷出多重细长水柱。
于该伸入步骤901中，将该冲鼻导管3的封闭末端从鼻前庭51经过隙缝状的鼻通道进入鼻咽52。因为柔软的冲鼻导管3在隙缝状的鼻腔中可以弯曲，不能以伸入长度判断其末端位置，因此于该导管位置确认步骤902中，取适量冲洗液加压灌入该冲鼻导管3以确认鼻咽52有水柱喷出代表冲鼻导管3已进入鼻咽(显示于图16)，或用内视镜确认导管末端的一部分边孔已进入鼻咽。于该设定步骤903中，将该冲鼻导管3连接到冲鼻导管专用自动注射器2、4，并设定每次灌注量、灌注速度、间歇时间及重复次数。于该灌注及退出步骤904中，通过该冲鼻导管专用自动注射器2、4执行多次灌注动作，并在灌注过程中慢慢将该冲鼻导管3向外退出，直到水柱在鼻前庭51喷出为止(显示于图17)，整个冲鼻导管3所经路径都进行完全清洗。于该重复步骤905中，再重复前述将冲鼻导管3经过其他隙缝状路径进入鼻咽52的伸入步骤901、导管位置确认步骤902、设定步骤903、灌注及退出步骤904，进行同样的清洗，当所有的鼻腔路径(见图1中的上鼻通道11、上邻中膈空间12、中邻中膈空间13、下邻中膈空间14、中鼻通道垂直段上半段15、中鼻通道垂直段下半段16、中鼻通道水平段17、下鼻通道垂直段18及下鼻通道水平段19)皆清洗完毕，鼻腔内的粘液及鼻屎必可清除干净，恢复到慢性鼻窦炎最早期没有鼻塞只有新排出的粘液的状态。这就是地毯式冲鼻法。
因为用注射筒以人工抽水及灌注，每个路径冲洗10次，所有路径完全冲洗约需30分钟，但以本发明的冲鼻导管专用自动注射器2、4只约需10分钟，可大大地节省执行者的体力及时间，执行者只执行技巧性的动作，导管冲鼻治疗将成为简单可行的标准治疗，达到快速改善症状的目的。
以上所述实施例仅是为充分说明本发明而所举的较佳的实施例，本发明的保护范围不限于此。本技术领域的技术人员在本发明基础上所作的等同替代或变换，均在本发明的保护范围之内。本发明的保护范围以权利要求书为准。
工业实用性
本发明实施例提供的一种冲鼻导管专用自动注射器及地毯式冲鼻法，通过塌陷冲鼻导管3经过每一个路径伸入鼻咽52，接上本冲鼻导管专用自动注射器2、4代替人工灌注冲洗液，导管慢慢退出，一面退出导管一面灌注冲洗液，喷出多重细长水柱清洗所经路径的粘液及鼻屎，每一路径5次、10次或15次或其他任何次数。此地毯式冲鼻法确实可以有效解决慢性鼻窦炎严重鼻塞的症状，恢复到没有鼻塞，只有粘液继续从鼻窦排出鼻腔的状态，只要简单的徒手洗鼻法就可保持下去，不再耗费巨大的医疗资源。要切除鼻甲还是要频繁冲洗鼻腔，病人可以自己选择。因此，具有工业实用性。

Claims (6)

  1. 一种冲鼻导管专用自动注射器，用以连接一具有封闭末端及多个边孔的冲鼻导管，能够灌注冲洗液从该多个边孔喷出多重细长水柱，并能够设定灌注量、灌注速度、暂停时间及重复灌注次数，其中，该冲鼻导管专用自动注射器包含：
    一冲洗液来源，及一与该冲洗液来源连接的冲洗液输送装置，该冲洗液输送装置包含一驱动冲洗液的动力单元。
  2. 根据权利要求1所述的冲鼻导管专用自动注射器，其中，
    该冲洗液输送装置是一个蠕动泵，该蠕动泵包括一泵槽、一设置于该泵槽的弹性圆管、一设置于该泵槽的转轮，及至少一个设置于该转轮外围的滚轮，该弹性圆管的两端分别连接该冲洗液来源及该冲鼻导管，该动力单元能够精准控制该蠕动泵的转速、转动周数、暂停时间及重复次数，以驱动该蠕动泵输送冲洗液，其中，该弹性圆管的弯曲模量不大于603MPa，外径与管壁厚度比不大于41.55。
  3. 根据权利要求1所述的冲鼻导管专用自动注射器，其中，
    该冲洗液输送装置包括一三向连接器、一具有一推杆的注射筒，及一注射筒驱动器，该注射筒驱动器包含一个动力转换单元，该三向连接器分别与该冲洗液来源、该注射筒，及该冲鼻导管连接，该三向连接器与该冲洗液来源之间设有一单向逆止阀，该注射筒与该动力转换单元连接，该动力转换单元再与该动力单元连接，该动力单元能够精准控制转速、转动周数、暂停时间及重复次数，该动力单元的圆周运动经由该动力转换单元转换为直线往复运动，以驱动该注射筒执行抽吸及输送冲洗液的动作。
  4. 根据权利要求1所述的冲鼻导管专用自动注射器，其中，
    该冲洗液输送装置包括一三向连接器、一具有一推杆的注射筒，及一流体动力控制机构，该三向连接器分别与该冲洗液来源、该注射筒，及该冲鼻导管连接，该三向连接器与该冲洗液来源之间设有一单向逆止阀，该流体动力控制机构包含一个方向控制单元及一个作用单元，该方向控制单元具有一个三位四通的流体控制阀，及一个用以控制该流体控制阀的开、关及暂停时间的方向控制模块，该作用单元具有一个流体储存箱、一个活塞模块及连接两者的一压力管及一回流管，该动力单元配合该方向控制单元能够驱动流体推动该活塞模块产生直线往复运动，并连接该注射筒执行抽吸及灌注冲洗液的动作。
  5. 根据权利要求2、3、4所述的冲鼻导管专用自动注射器，其中，该冲洗液输送装置与该冲鼻导管之间有一个单向逆止阀。
  6. 一种地毯式冲鼻法，适用于使用一具有封闭末端及多个边孔的冲鼻导管，及根据权利要求1至5中任一项所述的冲鼻导管专用自动注射器于鼻腔中喷出多重细长水柱，其中，该地毯式冲鼻法包含下列步骤：
    一伸入步骤，将该冲鼻导管的封闭末端从鼻前庭经过一个隙缝状路径进入鼻咽；
    一导管位置确认步骤，取适量冲洗液加压灌入该冲鼻导管以确认鼻咽有水柱喷出，或用内视镜确认至少导管末端已进入鼻咽；
    一设定步骤，将该冲鼻导管连接该冲鼻导管专用自动注射器，执行者在该冲鼻导管专用 自动注射器上设定每次的灌注量、暂停时间及灌注次数；及
    一灌注及退出步骤，通过该冲鼻导管专用自动注射器执行多次灌注动作，并在灌注过程中慢慢将该冲鼻导管退出，直到水柱在鼻前庭喷出为止，用以完全清洗所经路径的粘液及鼻屎。
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