WO2017063152A1 - 鼻腔冲洗导管 - Google Patents

鼻腔冲洗导管 Download PDF

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Publication number
WO2017063152A1
WO2017063152A1 PCT/CN2015/091911 CN2015091911W WO2017063152A1 WO 2017063152 A1 WO2017063152 A1 WO 2017063152A1 CN 2015091911 W CN2015091911 W CN 2015091911W WO 2017063152 A1 WO2017063152 A1 WO 2017063152A1
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WO
WIPO (PCT)
Prior art keywords
catheter
nasal
side holes
catheter body
irrigation catheter
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Application number
PCT/CN2015/091911
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English (en)
French (fr)
Inventor
吴丽秋
李慧萱
李苍牧
Original Assignee
吴丽秋
李慧萱
李苍牧
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Filing date
Publication date
Application filed by 吴丽秋, 李慧萱, 李苍牧 filed Critical 吴丽秋
Priority to JP2018518519A priority Critical patent/JP2018530391A/ja
Priority to PCT/CN2015/091911 priority patent/WO2017063152A1/zh
Priority to US15/765,937 priority patent/US20180280606A1/en
Priority to RU2018114063A priority patent/RU2695725C1/ru
Publication of WO2017063152A1 publication Critical patent/WO2017063152A1/zh

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    • 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0279—Cannula; Nozzles; Tips; their connection means
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61M25/00—Catheters; Hollow probes
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022—Volume; Flow rate
    • 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0262—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped manually, e.g. by squeezing a bulb
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • A61M2202/0233—Carbon monoxide
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/025—Materials providing resistance against corrosion
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0015—Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • A61M5/3291—Shafts with additional lateral openings

Definitions

  • the present invention relates to a nasal irrigation catheter, and more particularly to an innovative design that can penetrate the nasal cavity and the nasopharynx to clean the viscous secretions to improve the symptoms of chronic sinusitis.
  • Chronic sinusitis which is diagnosed with symptoms for more than 12 weeks, is not directly fatal, but it is a troublesome disease. At present, there is no cure for chronic sinusitis.
  • the three main symptoms include nasal congestion, foreign body sensation in the throat and cough that will continue to plague the patient for life.
  • Antibiotics can only control acute infections; antihistamines reduce secretions and worsen the symptoms of thicker mucus; decongestants are only transient and effective, and there is a rebound to worsen the symptoms; surgery is used to remove obstruction or enlargement Intranasal access to improve mucus discharge to avoid an acute onset of sinusitis. No matter what treatment, the disease is not cured, the symptoms of the symptoms have not changed, and the symptoms still exist. Therefore, otolaryngologists recommend long-term home treatments that moisturize at least twice a day. (Refer to chronic sinusitis, Medscape, Treatment, Long-term monitoring)
  • a sagittal section and a coronal section view of the nasal cavity of the human body the coronal section of the nasal cavity is a triangular shape with a narrow upper and a lower width, and the nasal cavity is divided into two left and right spaces by the nasal septum.
  • the nasal body between the wide front nasal vestibule 90 and the posterior nasopharynx 91 is divided into three curved slit-like passages by three curved plate-like structures, and a temporary space.
  • Each of the plate-like structures and the slit-like spaces are in the case of being small and large.
  • the gap space at the top of the secret may be less than 1 mm.
  • the three plate-like structures are called upper turbinate A, middle turbinate B and lower turbinate C, and the three slit-like spaces are upper nasal channel A1, middle nasal channel B1 and lower nasal channel C1.
  • the lower edge of the turbinate A, the middle turbinate B, and the lower turbinate C are divided into the upper middle space D1, the middle middle space D2, and the lower middle space D3.
  • the three turbinate, the middle turbinate and the side wall of the nasal cavity are skeletons composed of bones, and the surface is covered with mucous membranes, thereby increasing the surface area to have two functions: 1. Adjusting the humidity and temperature of the inhaled air. 2.
  • the three nasal passages are independent of each other except for the inward and medial space, forward and nasal vestibule 90 and rearward communicating with the nasopharynx. All mucus is secreted by four pairs of sinuses next to the nasal cavity and is expelled from several openings located in the upper nasal passage A1, the middle nasal passage B1 and the nasopharynx. Therefore, the upper concealment of the upper nasal passage A1 and the middle nasal passage B1 is upstream of the mucus discharge; the other part of the nasal cavity is downstream. Patients with chronic sinusitis often have severe nasal congestion symptoms and are unable to return to normal conditions, so it is difficult to recall the process of their occurrence, but their pathophysiology can be explained by the process of cold.
  • the nasal discharge can be understood by the process of the cold, the nose will flow in the early stage of the cold, the nasal water will be completely evaporated without the mucus; the next is the fluid but not easy to discharge; followed by the semi-solid colloid Half nose Finally, there is a solid nose that can be dug from the nasal vestibule 90.
  • Mucus, half nose and nose are three types of mucus.
  • the symptoms of chronic sinusitis are caused by the accumulation of mucus and nasal discharge in the nasal cavity. Cold symptoms do not exceed 4 weeks, and chronic sinusitis is a long-lasting disease. Only chronic sinusitis will last for more than 12 weeks. If the symptoms are more than 12 weeks and no other tumor or polyps cause nasal congestion, the diagnosis can be confirmed.
  • allergic rhinitis although there are severe nasal congestion symptoms, but must be accompanied by a large amount of nasal water, there will be no foreign body sensation of the throat, as long as the allergens disappear, it will return to normal, is an intermittent or seasonal disease, and chronic sinusitis It is a continuous disease.
  • the secretions of patients with chronic sinusitis are too viscous, and it is difficult to completely remove them, either by forceful blowing of the nose or by forceful aspiration.
  • the mucus that has not been removed and stays in the nasal cavity does not evaporate like the nasal water, but is formed by the dryness of the breathing air to form a scar, and adheres layer by layer to the nasal cavity and is located in the middle nasal passage B1 and upper nose.
  • the sinus opening of channel A1 spreads outward, eventually causing a persistent and severe nasal congestion.
  • mucus tends to adhere to a narrow space and is discharged from the opening of the upper nasal passage and the middle nasal passage, and the foremost part of the mucus, which is still in contact with the air, becomes the hardest crusting state. Therefore, it spreads from top to bottom, forming a mass suspended above the nasal cavity.
  • mucus tends to adhere to a narrow space and is discharged from the opening of the upper nasal passage and the middle nasal passage, and the foremost part of the mucus, which is still in contact with the air, becomes the hardest crusting state. Therefore, it spreads from top to bottom, forming a mass suspended above the nasal cavity.
  • There are also other patients with frequent blow nose so that there is not much mucus, but it is present in the nasal cavity in the form of scars, showing nasal passage stenosis, thickening of the turbinate, similar to the swelling of mucosa of allergic rhinitis. Regardless of whether the mass is large or small, the underside is dried into a hard crusting due to the continuous
  • the upper part is not exposed to air and the sinuses continue to secrete mucus, so they are all liquid mucus. This mucus can flow out to a small resistance, but if the mucus is blocked by various reasons, the mucus in the sinus can not be discharged to cause accumulation or even an acute attack.
  • the nasopharynx 91 which is the existing mucus backflow, is also difficult to remove by suction or swallowing action.
  • the fate of the mucus flowing into the nasopharynx is the same as that in the nasal cavity, and the process of drying and accumulating is repeated, and the nasopharynx 91 is a wide and deep breathing passage, and the mucus flowing into it is dried faster, one layer after another.
  • Mucus is exposed to the air to become a semi-nasal sputum, and a semi-sinus can become a hard snot. From the nose to the hard nose, the volume can be ten times different, and the time is long. Short depends on air humidity and circulation. Conversely, a hard nasal sputum can become a semi-nasal sputum after about one hour in the water, and a semi-sinus can become a mucus. This is the theoretical basis for flushing the nasal cavity. Medical experts all over the world recommend the traditional nasal device as a tool for flushing the nasal cavity. All the nasal devices have a similar structure.
  • the nasal wash device includes a pressing portion 10 and a nozzle 20.
  • the pressing portion 10 has an internal space 11 having a discharge port 21 and an extension tube portion 22 extending toward the internal space 11 of the pressing portion 10.
  • the inner space 11 is filled with water and is pressed from the outside to the inside to contract the pressing portion 10, the pressure pushes the water located in the inner space 11 into the extension pipe portion 22, and further, the discharge port 21 ejection.
  • This nasal device seems to wash the nose, but the results of our family and friends trial are not satisfactory.
  • a Chinese patent application No. 101125880 "Nose Channel Flushing Catheter Device" discloses a catheter 31 having a closed end and a plurality of side holes 32 at the proximal end.
  • the catheter 31 can penetrate the nasopharynx 91 via the middle nasal passage B1 and the lower nasal passage C1, and eject a water column 30 cm long and perpendicular to the catheter 31 in the nasal passage to be flushed.
  • the silicone irrigation catheter was hand-made for the family and friends. The initial effect was indeed much better than the traditional nasal device, confirming the above core problems, but the long-term trial is still not completely satisfactory.
  • the strongly pressurized water column is defined as a water column with a vertical height greater than 90 cm; the medium pressure water column is defined as a water column having a vertical height of 45 cm to 90 cm; and the low pressure water column is defined as a water column having a vertical height of less than 45 cm.
  • the vertical jetting water column is to penetrate the crucible thickness calculated in mm; but the parallel water column is to penetrate the length in cm, which is 10 times different.
  • the thickness of the scar required to penetrate the vertical water column on both sides of the catheter is at most half the width of the nasal passage, and the thickness is calculated in mm.
  • the nasal passage can only be cleaned with the aligned parallel water column, and the water column in other directions is Invalid, but the parallel water column needs to penetrate the knot of the entire nasal passage height, and the height of the nasal passage is about 2 ⁇ 3cm, so the flushing is invalid; in addition, although the parallel water column can enter the narrow space, it can wet the scar, but the scar absorbs the water. After the volume expands into mucus, the smaller the space is, the more viscous it is, the more difficult it is to discharge. Not only does it have no removal effect, but it is more severe due to volume expansion. This explains why the 30cm multi-slim water column cannot completely clean the nasal cavity.
  • the improvement method is as follows: 1. The method of enhancing the water column without increasing the outer diameter of the catheter: 2. Improving the handling of the small catheter, making it easy to penetrate into a narrow space.
  • medical experts around the world still recommend the traditional nasal device to flush the nasal cavity.
  • the front nasal irrigation device is just a document in the patent database of the world, which is not noticed and has not been commercialized. It is impossible for anyone to understand its merits. It is impossible to understand its merits, and it is impossible to make it for trial use. Of course, it is impossible to find its core problems, and it is impossible to propose solutions.
  • the object of the present invention is: 1. A method for enhancing the water column without increasing the outer diameter of the catheter; 2. Improving the handling of the small catheter, making it easy to penetrate into a narrow concealed portion, according to which the present invention provides a nasal irrigation catheter.
  • the present invention provides a nasal irrigation catheter comprising a catheter body and a set of adapters attached to the exterior of the catheter body, the catheter body being one of silicone, latex, thermoplastic elastomer or other soft and flexible
  • the material is made for the user (patient) to manually insert into the nasal cavity and the nasopharynx.
  • the catheter body has a closed end and an open end opposite to the closed end, and a plurality of side holes are formed near the closed end. .
  • the outer diameter of the catheter body is not more than 1.0 mm.
  • the outer diameter of the catheter body is not more than 1.0 mm
  • the shape of the side hole is a linear shape parallel to the catheter body.
  • Another technical means of the present invention is to provide a metal probe having a tapered end and rust-proof treatment in the above-mentioned irrigating duct.
  • Another technical means of the present invention is to provide a plurality of metal probes having a reduced length and rust-proof treatment in the above-mentioned irrigating duct.
  • the metal probe described above is a tungsten alloy probe having an outer diameter of not more than 0.1 mm and subjected to rustproof treatment.
  • the total area of the plurality of side holes in the duct body is between 3.367 mm 2 and 4.123 mm 2 .
  • Another technical means of the present invention is that the total area of the plurality of side holes on the catheter body is between 2.381 mm 2 and 3.367 mm 2 .
  • the total area of the plurality of side holes on the duct body is less than 2.381 mm 2 .
  • a further technical means of the present invention is that the closer the plurality of side holes on the catheter body are to the closed end, the denser the distribution.
  • the invention has the advantages that the built-in probe can improve the handling of the catheter, and the target area can be deeply washed, and the design of the adapter and the total area of the side holes can be used to spray multiple strong and slender water columns to achieve better. Flushing purpose.
  • Figure 1 is a sagittal cross-sectional view of the human nasal cavity
  • Figure 2 is a cross-sectional view of the posterior half of the nasal cavity of the line aa of Figure 1;
  • Figure 3 is a coronal cross-sectional view of the posterior half of the nasal cavity, illustrating the mucus and nasal discharge of patients with chronic sinusitis from the upper middle space, the upper nasal passage and the middle nasal passage to the lower middle space;
  • Figure 4 is a schematic cross-sectional view showing the "Portable Nasal Washer" of the Chinese Utility Model No. M418689;
  • Figure 5 is a perspective exploded view showing the "nose channel irrigation catheter device" of Taiwan No. 101125880;
  • Figure 6 is a perspective exploded view showing the first preferred embodiment of the nasal irrigation catheter heating of the present invention.
  • Figure 7 is a top plan view showing the conduit having a plurality of side holes that are densely distributed closer to the closed end;
  • Figure 8 is a partial cross-sectional view showing a second preferred embodiment of the nasal irrigation catheter of the present invention.
  • Figure 9 is a partial cross-sectional view showing a third preferred embodiment of the nasal irrigation catheter of the present invention.
  • Figure 10 is a partial cross-sectional view showing a fourth preferred embodiment of the nasal irrigation catheter of the present invention.
  • Figure 11 is a partial cross-sectional view showing a fifth preferred embodiment of the nasal irrigation catheter of the present invention.
  • Figure 12 is a partial cross-sectional view showing the engagement of an adapter of the present invention with the catheter body
  • Figure 13 is a partial cross-sectional view showing the engagement of the adapter of the present invention with the catheter body, and the safety design of the probe;
  • Figure 14 is a coronal cross-sectional view of the posterior half of the nasal cavity illustrating the curved and narrow path leading to the superior nasal passage and the mid-nasal passage;
  • Figure 15 is a sagittal cross-sectional view of the human nasal cavity illustrating the aspect in which the catheter is placed in the middle nasal passage for irrigation;
  • Figure 16 is a sagittal cross-sectional view of the human nasal cavity illustrating the aspect in which the catheter is placed in the upper nasal passage for irrigation;
  • Figure 17 is a coronal cross-sectional view of the human nasal cavity, illustrating the catheter placed in the lower middle space for rinsing;
  • Figure 18 is a sagittal cross-sectional view of the human nasal cavity illustrating the catheter placed in the nasopharynx and flushed.
  • H lower turbinate H1 lower nasal passage; I Linzhong space; I1 on the middle of the space;
  • 61 catheter body 611 closed end; 612 open end; 613 side hole; 614 end hole;
  • the nasal irrigation catheter 6 of the present invention can be infused with a syringe 7 to flush the nasal cavity and nasopharynx of the human body.
  • the first preferred embodiment is characterized in that the nasal irrigation catheter 6 comprises a catheter body 61 and a set of adapters 62 connected to the outside of the catheter body 61.
  • the catheter body 61 is made of silicone, latex or thermoplastic elastomer. One or other soft and elastic material is made available for the user (patient) to insert into the nasal cavity and the nasopharynx.
  • the catheter body 61 has a closed end 611 and a opposite end to the closed end 611.
  • An open end 612, and a plurality of side holes 613 are formed on the duct body 61 near the closed end 611, and the plurality of side holes 613 on the duct body 61 may be evenly distributed at the near closed end 611, or may be The denser the distribution (shown in Figure 7).
  • a second preferred embodiment of the nasal irrigation catheter 6 of the present invention is substantially the same as the first preferred embodiment, and the same is not described herein again, except that The nasal irrigation catheter 6 of the present invention also incorporates a metal probe 8 with a tapered end and rust-proof treatment.
  • a third preferred embodiment of the nasal irrigation catheter 6 of the present invention is substantially the same as the first preferred embodiment except that the number of metal probes 8 is multiple. And the length is decreasing.
  • the number of the plurality of probes 8 is three, and in actual implementation, other numbers may be used, unless otherwise limited.
  • a fourth preferred embodiment of the nasal irrigation catheter 6 of the present invention is substantially the same as the third preferred embodiment, and the same is not described herein again, except that
  • the outer diameter of the catheter body 61 is no more than 1.0 mm and is defined as a microcatheter. If the catheter is too soft to control, the nasal irrigation catheter 6 can also be provided with a plurality of tungsten alloy probes 8 having an outer diameter of not more than 0.1 mm and a reduced length by anti-rust treatment.
  • a fifth preferred embodiment of the nasal irrigation catheter 6 of the present invention is substantially the same as the fourth preferred embodiment, and the details are not described herein again, except that An end hole 614 is defined in the closed end 611 of the catheter body 61.
  • the nasal irrigation catheter 6 has an outer diameter of not more than 0.1 mm and an end.
  • a tungsten alloy probe 8 which is gradually rust-proofed.
  • the following is the manufacture of the nasal irrigation catheter 6 of the present invention, the relationship between the side hole and the vertical water column height, the manufacturing and quantity configuration of the side hole, the relationship between the catheter and the side hole, the design of the probe, the selection of the adapter, and the syringe. Detailed descriptions of each aspect, such as actual use operation and improvement of efficacy.
  • the catheter body 61 is made of silicone, latex, thermoplastic elastomer or other soft and elastic material.
  • the duct body 61 has an open end 612 and a closed end 611, and a plurality of side holes 613 are disposed at the near closed end 611.
  • the outer diameter of the catheter of the present invention is preferably 4 mm or less, and preferably 0.5 to 2.5 mm.
  • the outer diameter of the catheter is less than 1.0mm.
  • the microcatheter may have an inner diameter of only 0.6mm or even 0.3mm. It is easy to burst during the perfusion operation, and the closed end can reduce the risk if it is provided with an opening.
  • the wall of the tube is below 1 mm, preferably between 0.1 and 0.6 mm.
  • the present invention uses a 10 cc syringe 7 as a standard syringe.
  • a 10cc syringe can achieve a flow rate of 5cc/sec to 15cc/sec (IR, Injection Rate), so the intermediate value of 10cc/sec is selected as the standard perfusion rate, and a 30cm water column is required at this standard perfusion rate.
  • Total area of side hole 613 To produce a 45cm water column, the total area of the side holes is required. Similarly, to produce a 90 cm water column at a perfusion rate of 10 cc/sec, the total area of the side holes 613 is required.
  • the total area of the side hole 613 is between 3.367mm 2 ⁇ 4.123mm 2 may generate a low pressure conduit 30 ⁇ 45cm of water referred to the low-pressure conduit; side hole total area of between 2.381mm 2 ⁇ 3.367mm 2 can produce 45 ⁇ 90cm
  • the medium-pressure water column is called a medium-pressure pipe; the total area of the side holes is less than 2.381 mm 2 , and the pipe that can produce a high-pressure water column of 90 cm or more is called a high-pressure pipe. Since the water column of 30 cm can be ejected in the previous case, the low pressure water column of the present invention is defined as 30 to 45 cm.
  • the side apertures 613 can be made in a conventional manner to remove a portion of the wall of the tube, or can be fabricated using a vertebral solid needle penetration method.
  • the side hole size is from 0.1 mm to 1 mm, preferably from 0.2 mm to 0.5 mm.
  • the closer to the closed end the greater the lumen pressure, so the design of the near closed end 611 has a denser side hole 613 distribution (shown in Figure 8), avoiding local expansion of the end, allowing it to withstand the maximum The lumen pressure is used to eject the strongest water column.
  • the microcatheter can only withstand a small pressure, and it is suitable for very narrow spaces and does not require a high-pressure water column.
  • the purpose is to uniformly supply the rinsing liquid in a narrow slit-like space, and to manufacture the parallel to the catheter with a blade or a laser.
  • the linear edge hole allows it to increase the edge area without affecting the catheter structure to reduce the tube pressure during the perfusion operation.
  • the catheter can withstand high pressure, limited by the space of the nasal cavity, the catheter cannot be infinitely increased, and the height of the water column cannot be increased indefinitely. Therefore, the high pressure water column is only defined above 90cm.
  • the outer diameter of the duct body 61 is the same, the thicker the wall, the smaller the inner diameter, the higher the resistance to high pressure and the less the elastic fatigue. Elastic fatigue causes the side holes to expand, the total area of the side holes 613 to increase, and the water column to weaken.
  • the thicker the wall the smaller the inner diameter, the greater the perfusion resistance, the lower the perfusion rate and the lower the height of the water column.
  • the thickness of the wall and the inner diameter must be balanced. According to the above experiment, the stronger the water column, the better the flushing effect, but the flushing operation The stronger the feeling of tingling, and the milder the disease, the less sticky mucus, the lesser the nasal discharge, the medium or low pressure water column is enough to improve the symptoms, and the total area of the side hole of the medium or low pressure catheter is larger.
  • the side holes 613 are widely distributed and can be washed over a large range. Therefore, all three catheters have their own adaptation, and they all have their existence.
  • the catheter body 61 The larger the outer diameter, the thicker the wall of the catheter body 61, the harder and easier to operate, but limited by the narrow space of the nasal cavity, the outer diameter must be smaller than the narrow portion. If the material of moderate hardness is not found, the catheter body 61 may be too Soft and not easy to handle, it needs to be strengthened by other methods, and it needs to have a gradual softness at the end. Therefore, a rust-proof metal probe 8 is added to the lumen, and the probe 8 can be a single tapered end. Probe 8 or a plurality of probes 8 of decreasing length (shown in Figures 8 and 9).
  • the narrowest path of the patient's access to the upper nasal passage and the middle nasal passage may be less than 1.0 mm, or even only 0.5 mm wide, which must be overcome by a smaller catheter.
  • the inner diameter of the microcatheter less than 1.0 mm may be only 0.6 mm or even Less than 0.3mm, so the probe 8 must be smaller and the hardness must be larger. It is necessary to use a tungsten alloy probe that is rust-proofed and not more than 0.1mm (shown in Figure 10 and Figure 11) because tungsten is the hardest metal. .
  • the water outlet of the adapter is inserted into the water inlet of the catheter body, and if the adapter does not restrict the water flow, the catheter body is connected.
  • the area is stretched and the wall is thinner than the pressure of perfusion. Therefore, in this case, the water outlet of the adapter 62 is covered with a larger inner diameter outside the inlet of the conduit to solve the problem of water flow and perfusion pressure.
  • the joint between the two uses a friction between the two and a strong adhesive or other means to form a firm connection state.
  • microcatheter requires a built-in probe 8 because of its small inner diameter, and a jacketed adapter 62 (shown in Figure 12) is required.
  • the probe 8 can be designed safely at the junction to prevent the rinsing fluid from moving forward during the perfusion operation (shown in Figure 13).
  • the 10cc syringe 7 is the best choice for general patients because it is too large to handle and the flow rate is too large to cause side effects of drowning.
  • the use of the syringe 7 must also be adjusted in accordance with the diameter of the catheter body 61.
  • a 10 cc syringe 7 can be used; for the catheter body 61 of 1.5 to 2 mm, a syringe barrel 7 of 5 to 10 cc can be used; for the catheter body 61 of 1 to 1.5 mm, a syringe barrel of 1 to 5 cc can be used.
  • a microcatheter of 1 mm or less can be used with a syringe 2 of 1 to 2 cc in order to prevent the catheter from bursting.
  • a patient uses the catheter of Figure 5 in the previous case and has penetrated the nasal cavity (at least 8-10 cm or more) and still has no satisfactory flushing effect, it should be placed in the two target areas of the middle nasal passage and the upper nasal passage, or the water column. Insufficient strength to penetrate the nose. At this point, you should first seek the assistance of a physician, perform computed tomography of the nasal cavity and sinus, and do a computed tomography examination to help long-term flushing treatment. It should be worthwhile.
  • the nasal cavity of the human body is divided into three slightly curved slit passages by three plate-like structures, and the three plate-like structures are the upper turbinate F and the middle turbinate G, respectively. And the inferior turbinate H, and the three pathways are the upper nasal channel F1, the middle nasal channel G1 and the lower nasal channel H1.
  • this figure shows that the upper turbinate F, the middle turbinate G, and the inferior turbinate H are larger than normal, and the upper nasal passage F1, the middle nasal passage G1, and the lower nasal passage H1 are narrower than normal.
  • the catheter body 61 has good handling. As can be seen from Fig. 14, from the nasal vestibule E to the middle space I3, and then outward bending to reach the middle nasal passage G1, from the nasal vestibule E to the middle of the space I3 and the middle of the middle space I2, then External bending can reach the upper nasal passage F1.
  • the catheter body 61 When operating, the catheter body 61 is placed close to the middle of the nose, and the inner nasal cavity I3 is inwardly and upwardly and backwards into the nasal cavity for about 3 to 4 cm, and then bent outward to penetrate 6 to 7cm can reach the middle nasal passage G1 (this state is shown in Figure 15); if the catheter body 61 is close to the middle of the nose, along the lower middle space I3 and the middle of the middle space I2 and back into the nasal cavity about 5 ⁇ 6cm, then bend outward and go deep into 7 ⁇ 8cm to reach the upper nasal channel F1 target area (this state is shown in Figure 16). Since the conduit body 61 has reached the target zone directly, although the flow of the conduit is weak, the water column is sufficient to clean this very narrow space.
  • the mucus or crusting/sinus MC is deposited from the narrow upper nasal passage F1 and the middle nasal passage G1 to the lower middle space I3, and the air is accumulated. It does not circulate, but under the accumulation is a wide space for breathing air in and out, so its lower edge becomes a surface layer that contacts the breathing air, and it is easy to form a hard crusting/snoring. In this case, not only the water column running forward and backward of the commercially available rattle can not shake the knot/snot, but the 30cm water column generated by the "nose channel irrigation catheter device" in Fig. 5 also has insufficient penetrating power.
  • the medium and high pressure water column can have good penetrating power and clearing effect, and quickly improve the symptoms of the nasal congestion.
  • the nasopharynx J is a must-have for the wide breathing air, the mucus that falls into the nasopharynx J quickly becomes a hard crusting/snoring due to the drying of the air, and the commercially available rattle is in a single direction.
  • the water column can only wash the back wall of the nasopharynx J, can not wash the top and sides of the nasopharynx J, and if pressurized, its huge water column (mostly between 1 and 2 mm in diameter) must be accompanied by a large flow, easy to produce hydrophobic phenomenon.
  • the nasopharynx is an upright cavity, and the rinsing liquid cannot be retained, and the wetting time cannot be prolonged.
  • the 30cm water column of the catheter of the previous case can wash the mucus, but it has a poor effect on the penetrating/snoring penetration, and it is difficult to play a role in the nasopharynx J.
  • the user patient
  • the medium or high pressure catheter can be introduced horizontally from the lower nasal passage H1, the middle nasal passage G1 or the temporary middle space I into the nasopharynx J, and then the catheter can be upturned to reach the top of the nasopharynx J, and the injection is placed.
  • the barrel 7 can eject an ideal water column to remove mucus and crusting/snoring on the nasopharynx J.
  • the user can select a catheter having the probe 8 and suitable for the condition thereof, and because of its good handling, the catheter can be easily penetrated into the upper nasal passage F1, the middle nasal passage G1, and the lower nasal passage.
  • Channel H1 and nasopharynx J are used to remove mucus and scars/snot.
  • nasal irrigation catheter 6 of the present invention does have the following enhancements:
  • the pouring speed can be increased to produce a more powerful jet water column, and the effect of indirect flushing is enhanced.
  • the strength of the water column is designed by controlling the total area of the side holes 613, and the stronger the water column is, the better the cleaning effect is.
  • the position of the catheter body 61 at the nasopharynx J can be controlled, and the mucus and crusting/snoring on the nasopharynx J can be removed by a strong water column.
  • the nasal irrigation catheter of the invention can overcome the shortcomings that the existing nasal device cannot perform deep nasal irrigation, can truly improve the symptoms of the patient with chronic sinusitis, alleviate the suffering of the patient and save medical resources, so the object of the invention can be achieved.

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Abstract

一种鼻腔冲洗导管（6），以硅胶或其它柔软材质制成并可供病人自行操作；该导管（6）包括一封闭端（611）及一相反于该封闭端（611）的开放端（612）；该导管（6）于接近该封闭端（611）处开设多个边孔（613），如配合一衔接器（62）及一注射筒（7）可在鼻腔及鼻咽喷出多重强劲细长水柱，以清除黏液及鼻屎（MC）；该导管（6）可内含至少一探针（8）以改善操控性；在每秒10cc灌注速度下，边孔（613）总面积可以决定喷出的垂直水柱高度，并区分此导管（6）为：1.具有3.367mm2～4.123mm2的边孔（613）总面积，可以产生30～45cm水柱的低压导管（6）；2.具有2.381mm2～3.367mm2的边孔（613）总面积，可以产生45～90cm水柱的中压导管（6）及3.边孔（613）总面积小于2.381mm2，可产生90cm以上水柱的高压导管（6）。

Description

鼻腔冲洗导管 技术领域
本发明是有关于一种鼻腔冲洗导管，特别是指一种可深入鼻腔及鼻咽清洗黏稠分泌物，以改善慢性鼻窦炎症状的创新设计。
背景技术
以症状持续超过12周为诊断条件的慢性鼻窦炎虽不会直接致命，却是令人困扰的疾病。目前慢性鼻窦炎并无治愈的方法，三个主要症状包含鼻塞、喉咙异物感及咳嗽会持续终生困扰病人。抗生素只能控制急性感染；抗组织胺会减少分泌反而使黏液更浓症状更恶化；减充血剂只是短暂有效，且会有反弹作用使症状恶化；而外科手术则是用以移除阻塞或扩大鼻腔内通路以改善黏液排放，以避免鼻窦炎急性发作的手段。不管做何治疗，疾病并未治愈，产生症状的机转并未改变，症状仍然存在。因此，耳鼻喉科医师均建议每天至少湿润鼻腔两次的长期居家治疗。(参考chronic sinusitis,Medscape,Treatment,Long-term monitoring)
参阅图1、图2，为人体鼻腔内的矢状剖面与冠状剖面视图，鼻腔的冠状剖面是上窄下宽的三角形，鼻腔由鼻中膈分隔成左右两个空间。在每一个空间中，介于宽阔的前方鼻前庭90及后方鼻咽91之间的鼻腔本体是由三片弯曲的板状结构隔成三个弯曲的隙缝状通路，及一个临中膈空间。每个板状结构及隙缝状空间均呈上小下大的情形。最上方隐密处的隙缝状空间可能在1mm以下。此三片板状结构称为上鼻甲A、中鼻甲B及下鼻甲C，而三个隙缝状空间则为上鼻通道A1、中鼻通道B1及下鼻通道C1。临中膈空间以上鼻甲A、中鼻甲B、下鼻甲C下缘区分为上临中膈空间D1、中临中膈空间D2、下临中膈空间D3。三个鼻甲、鼻中膈及鼻腔侧壁均由骨骼构成骨架，表面再覆被黏膜，以此增加表面积使其具有两个功能:1.调节吸入空气的湿度及温度。2.过滤空气中颗粒状物质，预防其掉入气管及肺脏(参阅nasal cavity,wikipedia)。此三个鼻通道除向内与临中膈空间，向前与鼻前庭90及向后与鼻咽相通外，为彼此独立的空间。所有黏液都由鼻腔旁边的四对鼻窦分泌，并从位于上鼻通道A1、中鼻通道B1及鼻咽顶部的几个开口排出。因此上鼻通道A1及中鼻通道B1的上面隐蔽处是黏液排放的上游；而鼻腔其他部分是下游。慢性鼻窦炎病人求诊时多已有严重鼻塞的症状，而且无法回复正常状态，因此难以回忆其发生的过程，但其致病机转(pathophysiology)可由感冒的过程来说明。
鼻腔的排出物可以由感冒的过程来了解，感冒初期会流鼻水，鼻水是不含黏液的液体会完全蒸发；接下来是具流动性但不易排出的黏液；接着是呈半固态胶质状的半鼻屎； 最后则是可从鼻前庭90挖出的固态的鼻屎。黏液、半鼻屎及鼻屎是黏液的三种型态。慢性鼻窦炎的症状是黏液及鼻屎堆积在鼻腔本体所造成。感冒症状不会超过4星期，慢性鼻窦炎则是远为长久的疾病。只有慢性鼻窦炎才会症状持续超过12星期，如果症状超过12星期且无其他肿瘤或息肉造成鼻塞，即可确定诊断。另外，过敏性鼻炎，虽也有严重的鼻塞症状，但必定伴随大量的鼻水，不会有喉咙异物感，只要过敏原消失就会恢复正常，是间断性或季节性发作的疾病，而慢性鼻窦炎则是持续不断的疾病。
参阅图3，慢性鼻窦炎病患的分泌物，因过于黏稠，无论是用力擤鼻涕，或是用力抽吸都很难完全移除。未能移除而滞留在鼻腔的黏液不像鼻水会蒸发消失，而是受呼吸空气的干化缩小体积形成结痂，并且一层一层黏附于鼻腔内并自位于中鼻通道B1及上鼻通道A1的鼻窦开口向外漫延，终于造成持续且严重的鼻塞。黏液与其他流体不同，容易黏附在狭窄空间，且因从上鼻通道及中鼻通道的开口排出，而黏液的最前端即其最下部分因仍与空气接触，反而成为最坚硬的结痂状态，因此由上向下漫延，形成悬吊于鼻腔上方的团块。也有其他病人因常擤鼻涕(frequent blow nose)以致黏液不多，但却以结痂形态存在于鼻腔中，表现出鼻通道狭窄，鼻甲增厚的情形，类似过敏性鼻炎黏膜肿胀的情形。无论团块大或小，其下方都因不断有呼吸空气通过而干化成坚硬的结痂，上方则未接触空气而且鼻窦继续分泌黏液，因此都是液态的黏液。此黏液可以向阻力较小之处流出，但如黏液的四周因各种原因造成阻塞，则鼻窦内的黏液无法排出造成堆积甚至急性发作。
此黏液虽难以去除，但未完全干化之前仍会随着重力滑动。黏液如向前滑入鼻前庭90就成为现有的鼻涕或进一步干化成为鼻屎，因此结痂与鼻屎是同样的东西，以下均以结痂/鼻屎表示；也会向后滑入鼻咽91，此即现有的黏液倒流，也很难用抽吸或吞咽的动作来清除。流入鼻咽的黏液的命运也与在鼻腔内相同，会重复干化及累积的过程，而且鼻咽91是上下走向宽阔的呼吸通道，流入其内的黏液干化速度更快，一层一层的黏附其上形成厚厚的结痂。不管是液态的黏液或固态的结痂/鼻屎都会再向下滑落，都有掉入气管的可能，因此会引起喉咙异物感及咳嗽等症状，对病人的困扰不亚于鼻塞，持续的咳嗽甚至会限制病人的社交活动。鼻塞、喉咙异物感及咳嗽等症状也会影响睡眠，造成睡眠不足及精神不振的不良后果。最后，这些症状如果放任不管，黏液及结痂/鼻屎终将阻塞鼻窦出口，造成黏液堆积鼻窦内而引发急性鼻窦炎，需要严峻的内科和/或外科治疗，但急性发作控制之后，鼻窦持续分泌黏液仍然不变，症状仍然存在。
黏液三种型态的互相改变，可以在体外实验观察到。黏液暴露在空气中可成为半鼻屎，半鼻屎可成为坚硬的鼻屎。从鼻涕变成坚硬的鼻屎，体积可以相差十倍，其时间长 短依空气湿度及流通程度而定。反之，坚硬的鼻屎泡在水中约一小时后，可成为半鼻屎，半鼻屎可成为黏液。这是冲洗鼻腔的理论根据，全世界医学专家都推荐传统冲鼻器当作冲洗鼻腔的工具，所有的冲鼻器都具有相似的结构，参阅图4，以中国台湾实用新型第M418689号「随身洗鼻器」专利为例，该洗鼻器包括：一挤压部10及一喷嘴20。该挤压部10具有一内部空间11，该喷嘴20具有一喷出口21及一往该挤压部10内部空间11延伸的延伸管部22。当该内部空间11装有水并由外向内施压，而使该挤压部10收缩时，压力会将位于该内部空间11中的水推入该延伸管部22，进而由该喷出口21喷出。此冲鼻器似乎可以冲洗鼻腔，但是我们的家人及朋友试用的结果并不满意。
我们认为传统市售冲鼻器的核心问题在于其水柱方向，传统市售冲鼻器只能以一个放在鼻前庭的巨大喷嘴喷出由前向后单一方向的水柱。这样的水柱虽然可以在正常人冲洗全部的鼻腔，但在真正需要冲鼻治疗的鼻塞严重的慢性鼻窦炎病人只能经由鼻腔下方较宽较无阻塞的下鼻通道冲向鼻咽，无法抵达鼻腔上方狭窄阻塞的中鼻通道及上鼻通道。这些困难清洗的地方只能以导管放在中鼻通道及上鼻通道喷出垂直于前后走向的多重细小水柱才能有效清洗。因此我们提出鼻腔冲洗导管的专利申请。
参阅图5，中国台湾实用新型第101125880号「鼻信道冲洗导管装置」发明专利申请案，该案揭露了一种末端封闭、近末端处具有多个边孔32的导管31。该导管31可经由中鼻通道B1及下鼻通道C1深入鼻咽91，并在所需冲洗的鼻通道，喷出30cm长且垂直于导管31的水柱。从专利申请日之前，以手工制造silicone材质的鼻腔冲洗导管即给家人及朋友试用，初步疗效确实远优于传统冲鼻器，证实以上的核心问题，但长期试用仍未完全满意。实际上遭遇的问题是:导管若外径太小则难以操作，容易操控的导管则因太大只能放在中鼻通道或鼻腔下方较宽之处，无法抵达最深最狭窄处，但鼻腔高度只有5cm，为何30cm的多重细长水柱仍不能完全清洗鼻腔，为此我们设计以下实验：
先以黏液黏附于塑料板上待其干化成为结痂后，将其垂直置放以模拟冲洗液无法滞留鼻通道的状况，再以强压、中压、低压的水柱以各种角度喷射结痂。强压水柱定义为大于90cm垂直高度的水柱；中压水柱定义为介于45cm～90cm垂直高度的水柱；低压水柱定义为小于45cm垂直高度的水柱。这个实验的结果为水柱越强效果越佳及越接近垂直角度效果越佳。因为垂直喷射水柱所要穿透的是以mm计算的结痂厚度；但平行水柱所要穿透的是以cm计算的长度，两者相差达10倍。以此来看冲鼻治疗的实际操作，如导管置入鼻通道的目标区，则垂直水柱所需穿透位于导管两侧的结痂厚度至多是鼻通道宽度的一半，是以mm计算的厚度，因此很容易清洗；如果导管不能放入鼻通道的目标区，只能放在鼻通道的下面，则鼻通道只能以对正的平行水柱清洗，其他方向的水柱都 无效，但平行水柱需要穿透整个鼻通道高度的结痂，而鼻通道的高度约2～3cm，因此冲洗无效；另外平行水柱虽可进入狭窄的空间，可以湿润结痂，但结痂吸收水分后体积膨胀成为黏液，在越小的空间相对粘性越大，不易排出，不但没有清除效果，反而因体积膨胀阻塞更严重，这可以解释为何30cm的多重细长水柱无法完全清洗鼻腔。
这是前案鼻腔冲洗导管的核心问题，改善方法为1.不增加导管外径而可以增强水柱的方法:2.改善细小导管的操控性，使其易于深入狭窄的空间。在本案提出之日，全世界医学专家仍推荐传统冲鼻器冲洗鼻腔，而前鼻腔冲洗装置只不过是全世界如瀚海般的专利数据库中的一个文件，不会有人注意，而且尚未商品化，不可能有任何人了解其优点，既不了解其优点，也就不可能自己制造来试用，当然不可能发现其核心问题，也不可能提出解决方法。因为我们已依此改善方法制造出所需导管并供家人及朋友试用，确实可以改善前案鼻腔冲洗导管装置的缺点。从家人及好友的感受，我们深知慢性鼻窦炎病人的痛苦，必须尽快商品化提供病人使用，因此，我们提出本案的申请。
技术问题
因此，本发明的目的为：1.不增加导管外径而可以增强水柱的方法；2.改善细小导管的操控性，使其易于深入狭窄的隐密处，据此本发明提供一种鼻腔冲洗导管。
技术解决方案
本发明提供一种鼻腔冲洗导管，该冲洗导管包含一导管本体及一套接在该导管本体外部的衔接器，该导管本体是以硅胶、乳胶、热塑性弹性体其中之一或其它柔软且具弹性的材质制成，可供使用者(病人)自行操作置入鼻腔及鼻咽，该导管本体具有一封闭端及一相反于该封闭端的开放端，且靠近该封闭端处形成有多个边孔。
本发明的另一技术手段，是在于上述导管本体的外径不大于1.0mm。
本发明的又一技术手段，是在于上述导管本体的外径不大于1.0mm,其边孔形状为平行于导管本体之直线形。
本发明的另一技术手段，是在于上述的冲洗导管内更设置一支末端渐细并经防锈处理的金属探针。
本发明的又一技术手段，是在于上述的冲洗导管内更设置复数支长度递减并经防锈处理的金属探针。
本发明的另一技术手段，是在于上述的金属探针为外径不大于0.1mm并经防锈处理的钨合金探针。
本发明的再一技术手段，是在于上述的导管本体上的多个边孔的总面积介于3.367mm2～4.123mm2。
本发明的另一技术手段，是在于上述的导管本体上的多个边孔的总面积介于2.381mm2～3.367mm2。
本发明的又一技术手段，是在于上述的导管本体上的多个边孔的总面积小于2.381mm2。
本发明的再一技术手段，是在于上述的导管本体上的多个边孔越接近封闭端，越呈密集分布。
有益效果
本发明的有益效果在于，借由内置探针改善导管的操控性，可深入冲洗目标区，并借由衔接器及边孔总面积的设计，可以喷出多重强劲细长水柱，达到更佳的冲洗目的。
附图说明
图1是人体鼻腔内的矢状剖面视图；
图2是图1中线段aa鼻腔后半部的冠状剖面视图；
图3是一鼻腔后半部的冠状剖面视图，说明慢性鼻窦炎患者的黏液及鼻屎由上临中膈空间、上鼻通道及中鼻通道堆积到下临中膈空间的态样；
图4是剖面示意图，说明中国台湾实用新型第M418689号的「随身洗鼻器」；
图5是立体分解示意图，说明中国台湾第101125880号「鼻通道冲洗导管装置」；
图6是一立体分解示意图，说明本发明鼻腔冲洗导管发热第一较佳实施例；
图7是一上视示意图，说明该导管具有多个越靠近封闭端越呈密集分布的边孔；
图8是一局部剖视示意图，说明本发明鼻腔冲洗导管的第二较佳实施例；
图9是一局部剖视示意图，说明本发明鼻腔冲洗导管的第三较佳实施例；
图10是一局部剖视示意图，说明本发明鼻腔冲洗导管的第四较佳实施例；
图11是一局部剖视示意图，说明本发明鼻腔冲洗导管的第五较佳实施例；
图12是一局部剖视示意图，说明本发明的一衔接器与导管本体的衔接态样；
图13是一局部剖视示意图，说明本发明的衔接器与导管本体的衔接态样，以及探针的安全设计；
图14是一鼻腔后半部的冠状剖面视图，说明抵达上鼻通道及中鼻通道的弯曲及狭窄路径；
图15是人体鼻腔内的矢状剖面视图，说明该导管置于中鼻通道进行冲洗的态样；
图16是人体鼻腔内的矢状剖面视图，说明该导管置于上鼻通道进行冲洗的态样；
图17是人体鼻腔内的冠状剖面视图，说明该导管置于下临中膈空间进行冲洗的态样；
图18是人体鼻腔内的矢状剖面视图，说明该导管置于鼻咽并进行冲洗的态样。
图中：E鼻前庭；F上鼻甲；F1上鼻通道；G中鼻甲；G1中鼻通道；
H下鼻甲；H1下鼻通道；I临中膈空间；I1上临中膈空间；
I2中临中膈空间；I3下临中膈空间；J鼻咽；6鼻腔冲洗导管；
61导管本体；611封闭端；612开放端；613边孔；614端孔；
62衔接器；7注射筒；8探针；MC黏液或结痂/鼻屎。
本发明的实施方式
下面结合附图和具体实施例对本发明作进一步说明，以使本领域的技术人员可以更好的理解本发明并能予以实施，但所举实施例不作为对本发明的限定。
参阅图6、图7，为本发明鼻腔冲洗导管6的第一较佳实施例。在该第一较佳实施例中，该鼻腔冲洗导管6可配合一注射筒7灌注冲洗液以冲洗人体的鼻腔及鼻咽。
该第一较佳实施例的特征在于，该鼻腔冲洗导管6包含一导管本体61及一套接在该导管本体61外部的衔接器62，该导管本体61是以硅胶、乳胶、热塑性弹性体其中之一或其它柔软且具弹性的材质所制成，并可供使用者(病人)自行操作置入鼻腔及鼻咽中，该导管本体61具有一封闭端611及一相反于该封闭端611的开放端612，且该导管本体61上靠近该封闭端611处形成有多个边孔613，且该导管本体61上的多个边孔613可以是平均分布于近封闭端611处，也可以是越呈密集分布(显示于图7)。
参阅图8，为本发明鼻腔冲洗导管6的第二较佳实施例，该第二较佳实施例与该第一较佳实施例大致相同，相同之处于此不再赘述，不同之处在于，本发明的鼻腔冲洗导管6还内置有一支末端渐细并经防锈处理的金属探针8。
参阅图9，为本发明鼻腔冲洗导管6的第三较佳实施例，该第三较佳实施例与该第一较佳实施例大致相同，不同之处在于金属探针8的数量是多支且长度递减。本实施例中该多个探针8的数量为3根，实际实施时，也可以是其他数量，当不以此为限。
参阅图10，为本发明鼻腔冲洗导管6的第四较佳实施例，该第四较佳实施例与该第三较佳实施例大致相同，相同之处于此不再赘述，不同之处在于，该导管本体61的外径不大于1.0mm，并定义其为微导管。如导管太软难以控制，该鼻腔冲洗导管6内还可以设置多个支外径不大于0.1mm且长度递减经防锈处理的钨合金探针8。
参阅图11，为本发明鼻腔冲洗导管6的第五较佳实施例，该第五较佳实施例与该第四较佳实施例大致相同，相同之处于此不再赘述，不同之处在于，该导管本体61的封闭端611上更开设有一端孔614，该鼻腔冲洗导管6内置有一外径不大于0.1mm且末端 渐细经防锈处理的钨合金探针8。
以下就本发明的鼻腔冲洗导管6于导管的制造、边孔与垂直水柱高度的关系、边孔制造及数量配置、导管与边孔的相互关系、探针的设计、衔接器、注射筒的选用、实际使用操作，及功效增进等各个面向作详细的说明。
导管制造
该导管本体61由硅胶、乳胶、热塑性弹性体或其它柔软且具弹性的材质制成。该导管本体61具有一开放端612及一封闭端611，近封闭端611处设置有复数边孔613。鼻腔中最宽的下鼻通道H1及下临中膈空间I3，一般人在4mm以下，患者可能在2.5mm甚至1.5mm以下；最狭窄的上鼻通道F1，一般人在1.5mm以下，患者可能在1mm以下，因此，本案的导管外径以4mm以下为原则，较佳地，是介于0.5～2.5mm。导管外径小于1.0mm称微导管，其内径可能只有0.6mm甚至只有0.3mm，灌注操作中容易爆裂，其封闭端如加设开孔可降低此风险。管壁则在1mm以下，较佳地，是介于0.1～0.6mm。
边孔与垂直水柱高度的关系
边孔613水柱初始速度(V0)可以决定其垂直高度h，其等式如下：V0＝gt或t＝V0/g，其中g为重力常数9.8m/sec2、t为至垂直顶点的时间。最高垂直顶点为h，可以等式h＝1/2(gt2)表示，以t＝V0/g代入，则h＝1/2(g)(V0/g)2＝V0 2/2g或V0 2＝2gh，又边孔613水柱平均初始速度(V0)取决于速度灌注(IR)及边孔总面积(TA,Total Area)，其等式如下：V0＝IR/TA，以此代入等式V0 2＝2gh可得(IR/TA)2＝2gh，或TA2＝IR2/2gh，或
Figure PCTCN2015091911-appb-000001
虽然10cc、20cc、50cc、60cc及100cc的注射筒7都很容易取得，但考虑操作性及避免大流量的呛水副作用，不宜使用大容量的注射筒7，而10cc注射筒可以说是最佳的选择，因此，本发明以10cc注射筒7作为标准注射筒。一般徒手操作10cc注射筒可以达到5cc/sec至15cc/sec的速度灌注(IR,Injection Rate)，因此选择中间值10cc/sec作为标准灌注速度，于此标准灌注速度下要产生30cm的水柱，需要边孔613总面积
Figure PCTCN2015091911-appb-000002
要产生45cm的水柱，则需要边孔总面积
Figure PCTCN2015091911-appb-000003
同样地以10cc/sec的灌注速度要产生90cm的水柱，则需边孔613总面积
Figure PCTCN2015091911-appb-000004
综合以上，边孔 613总面积介于3.367mm2～4.123mm2可以产生30～45cm低压水柱的导管称为低压导管；边孔总面积在介于2.381mm2～3.367mm2可以产生45～90cm中压水柱的导管称为中压导管；边孔总面积小于2.381mm2，可产生90cm以上高压水柱的导管称为高压导管。因前案已可喷出30cm的水柱，因此本发明低压水柱定义为30～45cm。
边孔制造及数量配置
边孔613可以采用移除管壁的一部分的传统方式制作，也可以用椎状实心钢针穿刺方法制造。边孔大小以0.1mm至1mm为原则，较佳为0.2mm至0.5mm。4.123mm2边孔总面积可以制造0.5mm的圆形边孔，其数量为4.123mm2÷0.5mm÷0.5mm÷0.785＝21个，也可以制造58个0.3mm的圆形边孔或131个0.2mm圆形边孔；3.367mm2边孔总面积可以制造0.5mm的圆形边孔，其数量等于3.367mm2÷0.5mm÷0.5mm÷0.785＝17个，也可以制造47个0.3mm的圆形边孔或107个0.2mm的圆形边孔；同样地2.381mm2边孔总面积可以制造12个0.5mm圆形边孔，33个0.3mm圆形边孔或75个0.2mm圆形边孔。在灌注操作中，越接近封闭端之处，其管腔压力越大，因此设计近封闭端611有较密集的边孔613分布(显示于图8)，避免末端局部膨胀，使其能承受最大管腔压力，以喷出最强水柱。压力越大边孔需要越向封闭端611密集分布。边孔613总面积不变的情况下，边孔613越小，边孔613数量越多，分布也越广，可以冲洗更大范围；边孔613数量不变的情况下，边孔613越小总面积也会越小，所产生的水柱也越强。另外,微导管只能承受很小的压力,而且适用于非常狭小的空间也不需要高压水柱，其目的只是在狭小的隙缝状空间均匀地供输冲洗液，以刀片或激光制造平行于导管的线形边孔，使其在不影响导管结构前题下增加边孔面积，以降低灌注操作中的管压。
导管与边孔的相互关系
水柱高度虽取决于速度灌注(IR)及边孔总面积(TA,Total Area)，但前提是导管能够承受高压，受限于鼻腔的空间，导管无法无限增大，水柱高度也无法无限增大，因此，高压水柱只定义在90cm以上。导管本体61外径相同情形下，管壁愈厚，内径愈小，则愈耐高压而不易产生弹性疲劳。弹性疲劳会导致边孔扩大，边孔613总面积增加，水柱减弱的后果。但管壁愈厚、内径愈小灌注阻力愈大，使灌注速度降低也降低水柱高度，管壁厚度与内径大小必需取得平衡。依据前述实验，水柱愈强冲洗效果愈佳，但冲洗操作 中刺痛的感觉愈强，而且病情较轻者，黏液较不黏稠，坚硬的鼻屎较少，中压或低压水柱已经足以改善症状，且中压或低压导管的边孔总面积较大，边孔613分布较广，可以冲洗较大的范围。因此，三种导管都有其适应对象，都有其存在的必要。
探针的设计
外径越大、管壁越厚的导管本体61越硬也越易于操作，但受限于鼻腔的狭小空间，外径必须小于狭窄处，如不能找到软硬适中的材质则导管本体61可能太软而不易于操控，需要以其他方法增强其硬度，也需要具有末端渐进的柔软度，因此管腔内增设经防锈处理的金属材质探针8，该探针8可以是末端渐细的单一探针8或长度递减的多个探针8(显示于图8、图9)。另外，有病人抵达上鼻通道及中鼻通道的路径最狭窄处可能小于1.0mm，甚至只有0.5mm的宽度，必须更小的导管才能克服，此小于1.0mm的微导管内径可能只有0.6mm甚至小于0.3mm，因此探针8必须更小、硬度必须更大，必须采用防锈处理过且不大于0.1mm的钨合金探针(显示于图10、图11)，因为钨是硬度最大的金属。
衔接器
回顾图5，现有中国台湾第101125880号「鼻通道冲洗导管装置」，其衔接器的出水口是套入导管本体的入水口，其衔接器如不是限制了水流量，就是造成导管本体在衔接处被撑开，管壁变薄较无法承受灌注的压力。因此，本案改采衔接器62的出水口以较大内径包覆在导管入水口之外，解决水流量及灌注压力的问题。在衔接处利用两者之间的摩擦力及强力黏着剂或其他方法形成牢固的衔接状态。另外，微导管因为内径很小，又需要内置探针8，更需要外套式的衔接器62(显示于图12)。探针8可以在衔接处作一安全设计，预防灌注操作中随着冲洗液向前移动(显示于图13)。
注射筒的选用
虽然20cc、30cc，及50cc的注射筒7都很容易取得，但因体积太大不易操作，而且流量太大容易产生呛水的副作用，所以10cc注射筒是一般病人的最佳选择。但是，注射筒7的使用还必须配合导管本体61的管径作调整。外径2mm以上的导管本体61可使用10cc的注射筒7；1.5～2mm的导管本体61可使用5～10cc的注射筒7；1～1.5mm的导管本体61可使用1～5cc的注射筒7；1mm以下的微导管为避免导管爆裂可使用1～2cc的注射筒7。
实际使用操作
因为手工制造的前案导管，在专利申请前已在家人及好友之中试用，而且本案的导 管也试用多时，因此我们熟悉冲洗鼻腔的所有细节，并且体认：因为需要每天冲洗鼻腔，冲洗的效果病人自己最清楚。评估效果的项目有二，其一是客观上冲洗中及冲洗后黏液流出的量，越多越好；其二是主观上冲洗后，鼻塞、喉咙异物感、咳嗽及睡眠质量不佳等症状的改善程度。必须两者都满意至少也要可以接受才算有效，病人才会继续使用。如果有病人使用前案图5的导管且已深入鼻腔(至少深入8～10cm以上)仍然没有满意的冲洗效果，则应该是没有放入中鼻通道及上鼻通道两个目标区，或是水柱强度不足以穿透鼻屎所致。此时应该先寻求医师的协助，施行鼻腔、鼻窦的计算机断层摄影，做一次计算机断层摄影检查有助于长期的冲洗治疗，应该是值得的。
如果此计算机断层摄影检查的结果如图14所示，人体的鼻腔是由三片板状结构隔成三个稍微弯曲的隙缝通路，此三片板状结构分别为上鼻甲F、中鼻甲G，及下鼻甲H，而三个通路则为上鼻通道F1、中鼻通道G1及下鼻通道H1。虽然没有很多黏液或鼻屎MC造成阻塞，此图显示上鼻甲F、中鼻甲G，及下鼻甲H比正常人大，且上鼻通道F1、中鼻通道G1及下鼻通道H1比正常人狭窄，应该是坚硬的鼻屎黏附在鼻甲使其变大所造成的狭窄，又如果所使用的导管外径大于狭窄处，则冲洗效果不佳可确认是未能进入目标区所致。因此必须检视从前到后所有的冠状剖面图，量出其抵达路径中最小的宽度，选用小于此宽度的导管本体61。由于探针8的设计使导管本体61具有良好的操控性。由图14可见，从鼻前庭E经下临中膈空间I3，再向外弯曲即可抵达中鼻通道G1，从鼻前庭E经下临中膈空间I3及中临中膈空间I2，再向外弯曲即可抵达上鼻通道F1，操作时将导管本体61紧贴鼻中膈沿着下临中膈空间I3向内向上并向后深入鼻腔约3～4cm，再向外弯曲共深入6～7cm即可抵达中鼻通道G1(此状态显示于图15)；如果将导管本体61紧贴鼻中膈沿着下临中膈空间I3及中临中膈空间I2并向后深入鼻腔约5～6cm，再向外弯曲共深入7～8cm即可抵达上鼻通道F1目标区(此状态显示于图16)。因为该导管本体61已直接抵达目标区，虽然此导管的流量小水柱弱，但已足够清洗此非常狭窄的空间。
如果此计算机断层摄影检查的结果如图17所示，由于黏液或结痂/鼻屎MC自狭窄的上鼻通道F1及中鼻通道G1向下堆积至下临中膈空间I3，堆积之处空气不流通，堆积处之下则为呼吸空气进出的宽阔空间，因此其下缘反而成为接触呼吸空气的表层，易形成坚硬的结痂/鼻屎。这种情况不但市售冲鼻器前后走向的水柱无法撼动此结痂/鼻屎，图5的「鼻通道冲洗导管装置」所产生上下左右30cm水柱也穿透力不足，此时可依病情严重程度，选用中压导管或高压导管放置于结痂/鼻屎下方的下临中膈空间I3，利用 强劲的水柱向上喷射，正如前述的喷射实验，中、高压水柱可以有很好的穿透力及清除效果，很快地改善鼻塞的症状。
参阅图18，因为鼻咽J是宽阔的呼吸空气必经之处，掉入鼻咽J的黏液因为空气的干化作用很快变成坚硬的结痂/鼻屎，市售冲鼻器单一方向的水柱，只能冲洗鼻咽J后壁，无法冲洗鼻咽J顶部及两侧，而且如加压，其巨大水柱(直径大多在1～2mm之间)必定伴随大流量，容易产生呛水的现象。而且鼻咽是直立的空腔，冲洗液无法滞留，无法延长湿润的时间。前案导管的30cm水柱，虽可冲洗黏液，但对结痂/鼻屎穿透力不足效果不佳，在鼻咽J处难以发挥作用，这种情况下，依病情严重性，使用者(病人)可将中压或高压导管顺着水平方向从下鼻通道H1、中鼻通道G1或临中膈空间I进入鼻咽J，再将导管往上翘可抵达该鼻咽J顶部，套上注射筒7可以喷出理想的水柱，清除鼻咽J上的黏液及结痂/鼻屎。
经由上述说明可知，使用者(病人)可选用具有探针8并适合其病情的导管，因其具有良好的操控性，可以很容易将导管深入该上鼻通道F1、中鼻通道G1、下鼻通道H1及鼻咽J中，以效清除其中的黏液及结痂/鼻屎。
经由以上实施例的叙述，可知本发明鼻腔冲洗导管6确实具有以下功效增进之处：
一、借由易于操控的微导管使直接冲洗狭窄的鼻通道成为可能。
二、因为衔接器62的改进，在不加大管径的条件下，可以增加灌注速度产生更为强劲的喷射水柱，增强间接冲洗的效果。
三、以控制边孔613总面积的方法设计水柱的强度，水柱越强清除效果越佳。
四、借由导管的操控性可以控制导管本体61在鼻咽J的位置，并利用强劲的水柱清除鼻咽J上的黏液及结痂/鼻屎。
本发明鼻腔冲洗导管，可克服现有冲鼻器无法进行鼻腔深处冲洗的缺点，可真正改善慢性鼻窦炎患者的症状，减轻病人的痛苦并节省医疗资源，因此确实可以达成本发明的目的。
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。

Claims (14)

  1. 一种鼻腔冲洗导管，包含一导管本体及一套接在该导管本体外的衔接器，可配合一注射筒灌注冲洗液以冲洗鼻腔及鼻咽，其特征在于：
    该导管本体以硅胶、乳胶、热塑性弹性体其中之一或其它柔软且具弹性的材质制成，能够供病人自行操作置入鼻腔及鼻咽，该导管本体具有一封闭端及一相反于该封闭端的开放端，且靠近该封闭端处形成有多个边孔。
  2. 根据权利要求1所述的鼻腔冲洗导管，其特征在于：其中，该导管本体的外径不大于1.0mm。
  3. 根据权利要求1所述的鼻腔冲洗导管，其特征在于：其中，该导管本体的外径不大于1.0mm,其边孔形状为平行于导管本体的直线形。
  4. 根据权利要求1所述的鼻腔冲洗导管，其特征在于：其中，该冲洗导管内还设置一支末端渐细并经防锈处理的金属探针。
  5. 根据权利要求1所述的鼻腔冲洗导管，其特征在于：其中，该冲洗导管内还设置多支长度递减并经防锈处理的金属探针。
  6. 根据权利要求2或3所述的鼻腔冲洗导管，其特征在于：其中，该冲洗导管内还设置一支末端渐细并经防锈处理的金属探针。
  7. 根据权利要求2或3所述的鼻腔冲洗导管，其特征在于：其中，该冲洗导管内还设置多支长度递减并经防锈处理的金属探针。
  8. 根据权利要求6所述的鼻腔冲洗导管，其特征在于：其中，该金属探针为外径不大于0.1mm并经防锈处理的钨合金探针。
  9. 根据权利要求7所述的鼻腔冲洗导管，其特征在于：其中，该金属探针为外径不大于0.1mm并经防锈处理的钨合金探针。
  10. 根据权利要求1、4、5中任一项所述的鼻腔冲洗导管，其特征在于：其中，该导管本体上的多个边孔的总面积介于3.367mm2～4.123mm2。
  11. 根据权利要求1、4、5中任一项所述的鼻腔冲洗导管，其特征在于：其中，该导管本体上的多个边孔的总面积介于2.381mm2～3.367mm2。
  12. 根据权利要求1、4、5任一项所述的鼻腔冲洗导管，其特征在于：其中，该导管本体上的多个边孔的总面积小于2.381mm2。
  13. 根据权利要求11所述的鼻腔冲洗导管，其特征在于：其中，该导管本体上的多个边孔越接近封闭端，越呈密集分布。
  14. 根据权利要求12所述的鼻腔冲洗导管，其特征在于：其中，该导管本体上的多个边孔越接近封闭端，越呈密集分布。
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