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WO2018119561A1 - 可塌陷鼻腔喷射导管 - Google Patents

可塌陷鼻腔喷射导管 Download PDF

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Publication number
WO2018119561A1
WO2018119561A1 PCT/CN2016/112048 CN2016112048W WO2018119561A1 WO 2018119561 A1 WO2018119561 A1 WO 2018119561A1 CN 2016112048 W CN2016112048 W CN 2016112048W WO 2018119561 A1 WO2018119561 A1 WO 2018119561A1
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WO
WIPO (PCT)
Prior art keywords
catheter
nasal
closed end
nasal cavity
space
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2016/112048
Other languages
English (en)
French (fr)
Inventor
吴丽秋
李慧萱
李苍牧
李子瑜
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Patent Wide International Corp
Original Assignee
Patent Wide International Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Patent Wide International Corp filed Critical Patent Wide International Corp
Priority to PCT/CN2016/112048 priority Critical patent/WO2018119561A1/zh
Priority to AU2017385152A priority patent/AU2017385152B2/en
Priority to MX2019005511A priority patent/MX2019005511A/es
Priority to CA3042315A priority patent/CA3042315C/en
Priority to EP17888460.7A priority patent/EP3560476B1/en
Priority to ES17888460T priority patent/ES2951639T3/es
Priority to PCT/CN2017/118170 priority patent/WO2018121459A1/zh
Priority to CN201780058655.6A priority patent/CN110799166B/zh
Priority to JP2019517405A priority patent/JP6902095B2/ja
Priority to KR1020197010936A priority patent/KR102222656B1/ko
Priority to BR112019010682A priority patent/BR112019010682A2/pt
Priority to US16/349,427 priority patent/US11000450B2/en
Publication of WO2018119561A1 publication Critical patent/WO2018119561A1/zh
Priority to IL267256A priority patent/IL267256B/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • 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
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/01—Constructive details
    • A61H2201/0173—Means for preventing injuries
    • 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
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/12—Driving means
    • A61H2201/1253—Driving means driven by a human being, e.g. hand driven
    • 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
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/02—Head
    • A61H2205/022—Face
    • A61H2205/023—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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0025—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter having a collapsible lumen
    • 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
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0681—Sinus (maxillaris)
    • 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

Definitions

  • the invention relates to a nasal irrigation catheter, in particular to a collapsible nasal injection catheter which can penetrate deep into the nasal cavity and clean the viscous secretions of the nasopharynx 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. Symptoms such as nasal congestion, foreign body sensation of the throat and cough will continue to plague the patient, even for a lifetime. Antibiotics are only treatments for acute infections, and the purpose of surgery is to remove obstructions or enlarge intranasal access to improve mucus emissions and avoid acute exacerbations of sinusitis. No matter what treatment, the disease does not change, the symptoms still exist. Therefore, otolaryngologists recommend long-term home treatment with moist nasal cavity. It is generally recommended to moisturize the nasal cavity at least twice a day because it cannot be cured and needs life-long home treatment. . (Wikipedia, key word: chronic sinusitis, Medscape, Treatment, Long-term monitoring)
  • the sagittal section and the coronal section of the human nasal cavity are similar to the appearance of the nose.
  • the front of the nasal cavity presents a narrow, wide triangle, 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 slightly curved slit-like passages by three curved plate-like structures, and a temporary space. .
  • the three plate-like structures that are gradually enlarged from the top to the bottom are called the upper turbinate A, the middle turbinate B, and the inferior turbinate C, and the three upwardly and downwardly enlarged passages are the upper nasal passage A1 and the middle nasal passage B1. And the lower nasal passage C1.
  • the middle nasal passage is often divided into a descending section of about 2 cm (B1D) and a horizontal section of about 1 cm (B1H).
  • the lower edges of the middle, lower, middle and lower turbinate A, B, and C are divided into upper, middle, and lower median spaces D1, D2, and D3.
  • the anterior and posterior diameter of the nasal cavity is about 5cm
  • the middle turbinate B, the inferior turbinate C, the middle nasal channel B1 and the lower nasal passage C1 are both 5cm; while the upper turbinate A and the upper nasal channel A1 only occupy the posterior half of the nasal cavity, and the anteroposterior diameter is about 2.5cm.
  • the three turbinate, the nasal sac and the nasal wall are composed of skeletons, and the surface is covered with mucous membranes. The surface area is increased to make the space of the nasal cavity a slit-like passage and has two functions: 1. Adjusting the humidity of the inhaled air And temperature. 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 (maxillary sinus, prefrontal sinus, sinus sinus, sphenoid sinus) next to and above the nasal cavity, and from the upper nasal passage A1 (one third of the posterior sinus), the middle nasal passage B1 (two-thirds of the maxillary sinus, prefrontal sinus and anterior sinus sinus) and several small circular openings (usually 1 mm or less) of the nasopharynx (the sphenoid sinus) are discharged.
  • 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 discharge of the nasal cavity can be understood by the process of the cold.
  • the nose will flow in the early stage of the cold, the nasal water will completely evaporate without the mucus; the next is easy to discharge the slightly sticky nose; then it is not easy to discharge and thick.
  • Mucus; followed by semi-solid colloid The shape of the semi-nasal snot; the last is a solid snot that can be excavated from the nasal vestibule 90, which is the four types of mucus.
  • Chronic sinusitis is a symptom caused by the accumulation of mucus and nasal discharge in the nasal cavity. The symptoms of colds do not exceed 4 weeks.
  • Chronic sinusitis is a disease that secretes mucus without knowing the cause. Only chronic sinusitis can last for more than 12 weeks.
  • the diagnosis can be confirmed.
  • allergic rhinitis although there are severe nasal congestion symptoms, but there must be a large amount of nasal water, there is no throat foreign body sensation, as long as the allergens disappear, it will return to normal, is a periodic or seasonal disease of intermittent episodes, and The symptoms of chronic sinusitis are caused by too little nasal juice and too much mucus. The symptoms are that the patient will be plagued for years.
  • 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.
  • Mucus easily adheres to a narrow space causing local obstruction, and obstruction allows no air to pass through and thus less contact with air to maintain a liquid state.
  • gravity exceeds adhesion, it moves forward or downward along gravity in a patient's posture. Sliding forward into the nasal vestibule 90 or downward into the larger space below becomes a conventional nasal sputum, which further becomes dry into a snot; it also slides back into the nasopharynx 91, which is known as mucus backflow. It is difficult to remove by suction or swallowing action.
  • the mucus that has not been removed and stays in the nasal cavity does not evaporate like the nasal water. If it slides into a larger space, it becomes a thin layer. Because it is not completely blocked, it will be dried by the breathing air to reduce the volume. It spreads out of the nasal cavity and from the sinus opening in the middle nasal passage B1 and the upper nasal passage A1, finally causing persistent and severe nasal congestion. The mucus continues to drain from the opening of the upper nasal passage and the middle nasal passage, forming a state of suspension above the nasal cavity, and the foremost end of the mucus, which is still in contact with the air, becomes the hardest nasal state.
  • the fat flow into the nasopharynx is also the same as 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 more rapidly dried, regardless of the liquid state. Mucus or solid nasal sputum will slide down again, and there is a possibility of falling into the trachea, which can cause symptoms such as foreign body sensation and cough in the throat. It is no more than a nasal congestion, and the continuous cough can even limit the social activities of the patient. . Nasal congestion, throat foreign body sensation and coughing can also affect sleep, resulting in poor sleep and lack of energy.
  • the snot can be mucus when exposed to the air.
  • the mucus can become a semi-snoring when exposed to the air, and the semi-nasal sin can become a hard snot.
  • the volume can be ten times different, depending on the air humidity and circulation.
  • the hard nasal sputum can become a semi-snoring after about one hour in the water, and the semi-nasal sputum can become mucus, and it can become a snot after a longer time.
  • the nasal cavity is a complex structure of three narrow passages and a narrow gap formed by a temporary space. It is not a hollow space that is empty.
  • the nasal cavity can be from the nasal vestibule 90 to the outside of the body, or from the nasopharynx to the oral cavity to the outside of the body. It is also the open space outside the body that is unique to the body (the oral cavity is also an open space, but the muscle group can move autonomously, it belongs to The void space that can be opened and closed).
  • the following experiment simulates the mechanism of flushing the nasal cavity as follows: the horizontal water column sprays the mucus, the semi-nasal sputum and the nasal sputum adhered to the upright plastic plate, and the water column strength is further divided into the low-pressure water column below 45 cm, 45 cm to 90cm medium pressure water column and high pressure water column above 90cm. It can be observed that the low-pressure water column can make the mucus into a thin nasal sputum, and can also make the surface of the semi-nasal sin become mucus, but can not change the hard snot; the medium-pressure water column can make the mucus and the semi-nasal sputum become easy to flow.
  • the snot can also make the surface of the hard sin become thick mucus; the high-pressure water column can make the hard snot peel off directly, and the semi-nasal mucus and snot can be washed away directly. Therefore, the flushing effect is directly related to the vertical height of the water column.
  • the invention of Taiwan Patent No. I542371 is filed by the applicant (hereinafter referred to as the previous case), the purpose of which is to improve the disadvantages of the original nasal irrigation catheter invention No. I515025.
  • the improvement method is as follows: 1.
  • the height of the water column is controlled by the total area of the side holes, and the height of the water column is divided into high pressure, medium pressure, and low pressure conduit 611, but the high pressure conduit 611 must use a larger pressure-resistant conduit 611, which is a high pressure conduit.
  • indwelling probe 8 in the lumen improves the handling of the microcatheter, but the microcatheter 611 water column is weakly flushed, and the actual manufacturing of the 1 mm outer diameter catheter is not easy, but the nasal cavity of the severe patient is even as small as 0.5 mm. Difficult to penetrate; and microcatheters also have the risk of getting into the sinus.
  • the technical problem to be solved by the present invention is that the prior art nasal irrigation catheter is inconvenient to use.
  • the object of the present invention is to design an effective and easy to operate catheter, in particular, to design a
  • the powerful water column is sprayed into the multi-functional catheter that can penetrate deep into the narrow space without erroneously entering the sinus.
  • the method of the present invention provides a collapsible nasal jet catheter which can be filled with a syringe to flush the nasal cavity and the nasopharynx;
  • the catheter comprises a catheter body and an adapter, the catheter body having a flat closure An end portion and an open end opposite to the flat closed end, and a plurality of side holes formed adjacent to the flat closed end;
  • the catheter body is made of a thermoplastic elastomer or other soft and elastic material for the patient
  • the nasal cavity and the nasopharynx are disposed by themselves, and the minimum wall thickness of the catheter body is not more than 0.45 mm, and the maximum width of the flat closed end is not less than 1 mm.
  • Another technical means of the present invention is that the maximum width of the flat closed end is greater than the minimum diameter of the catheter body.
  • the catheter has a hardness of less than 80 Shore A and a wall thickness of not more than 0.45 mm.
  • the above-mentioned duct has a hardness of 80 to 90 Shore A and a wall thickness of not more than 0.40 mm.
  • the catheter has a hardness of 90 Shore A or more and a tube wall thickness of not more than 0.35 mm.
  • the beneficial effect of the invention is that the flat closed end of the catheter and the collapsibility make it easy to follow the slit-like space in the nasal cavity, enter a narrow space far smaller than the outer diameter of the catheter, and eject a relatively strong slender water column. For better irrigation purposes, and to avoid getting into the sinus.
  • 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 a-a 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 "nasal irrigation catheter" of the Chinese Patent No. I542371;
  • Figure 5 is a partial cross-sectional view showing the interface between the adapter of the "nasal irrigation catheter" of the Chinese invention No. I542371 and the catheter body, and the safety design of the probe;
  • Figure 6 is a perspective exploded view showing the composition of the nasal injection catheter of the present invention.
  • Figure 7 is a schematic cross-sectional view showing the natural state of the catheter body of the present invention.
  • Figure 8 is a schematic cross-sectional view showing the collapsed state of the catheter body of the present invention.
  • Figure 9 is a partial cross-sectional view showing the end of the catheter body and the flat closed end of the present invention.
  • Figure 10 is a schematic cross-sectional view of line segment b-b of Figure 9;
  • Figure 11 is a schematic cross-sectional view of line segment c-c of Figure 9;
  • Figure 12 is a coronal cross-sectional view of the posterior half of the nasal cavity illustrating the aspect of the high pressure catheter of the invention No. I542371 which can only be placed in the horizontal section of the middle nasal passage;
  • Figure 13 is a coronal cross-sectional view of the posterior portion of the nasal cavity illustrating the manner in which the collapsible nasal jet catheter of the present invention can be placed into the descending section of the mid-nasal passage;
  • Figure 14 is a coronal cross-sectional view of the posterior half of the nasal cavity, illustrating the collapsible nasal jet catheter of the present invention can be placed into the upper median space;
  • Figure 15 is a coronal cross-sectional view of the posterior half of the nasal cavity illustrating the manner in which the collapsible nasal jet catheter of the present invention can be placed into the superior nasal passage;
  • Figure 16 is a sagittal cross-sectional view of the nasal cavity of a human body illustrating the manner in which the collapsible nasal jet catheter of the present invention can be flushed into the nasopharynx via the superior nasal passage.
  • D1 is on the middle of the space
  • a collapsible nasal spray catheter 6 of the present invention can be used in conjunction with a syringe 7 to perfuse the irrigation fluid to flush the nasal cavity and nasopharynx of the human body.
  • the collapsible nasal cavity ejection catheter 6 comprises a catheter body 61 and an adapter 62.
  • the catheter body 61 is made of a thermoplastic elastomer or other soft and elastic material, and can be placed into the nasal cavity and the nasopharynx by the patient.
  • the duct body 61 has a flat closed end 611 and an open end 612 opposite to the flat closed end 611, and a plurality of side holes 613 are formed in the duct body 61 near the flat closed end 611.
  • the syringe 7 has a receiving member 71 and a pressing member 72 disposed in the receiving member 71.
  • the receiving member 71 can hold liquid therein, and the pressing member 72 will accommodate the pressing member 72.
  • the liquid is squeezed into the duct body 61 and is ejected outward from the plurality of side holes 613 by pressure.
  • One end of the adapter 62 is an open end 612 that connects the catheter body 61, and the other end is connected to the syringe 7 to deliver the liquid in the syringe 7 into the catheter body 61.
  • a cross-sectional view of the catheter body 61 is defined by a tube wall 614 and a lumen 615 defined by the tube wall 614 for containing liquid and for rinsing liquid to pass.
  • the tube wall 614 is made of a soft and resilient material so that the tube wall 614 forms a perfect circle in its natural state (as shown in Figure 7). However, after an external force is applied from the outside of the tube wall 614 (not shown in Figures 7 and 8), the tube wall 614 will collapse and form an ellipse (as shown in Figure 8).
  • the line segment bb is an area where a plurality of side holes 613 are provided.
  • the line segment cc is flat of the duct body 61.
  • the closed end 611 is a flattened closure of the catheter body 61 by hot melt, glue or other means.
  • the catheter body 61 near the flat closed end 611 must be elliptical and then gradually transition to the original circular shape of the catheter.
  • the long diameter of the ellipse must be larger than the diameter of the circle, and the short diameter of the ellipse must be smaller than the diameter of the circle. This transition length depends on the material hardness, the wall thickness, and the inner and outer diameter of the conduit.
  • the first feature collapsibility.
  • the pipe made of elastic material will be deformed when the pressure is applied, and the pressure will be restored to the original shape.
  • the greater the pressure the larger the deformation, but the smaller the outer diameter, the harder the material and the greater the thickness of the pipe wall 614, the greater the resistance to deformation, and vice versa.
  • the pressure required to get closer to the complete collapse deformation is greatly increased, so that the efficiency of collapse of the lumen 615 is optimal, so that the collapse of the lumen 615 is defined as collapseable.
  • the catheter 61 and the nasal mucosa are mutually squeezed, and the lumen 615 collapses half without causing pain and is said to be injurious.
  • the outer diameter of 3mm is set as the standard catheter size, and then the standard size catheter of various hardness materials is pressed at the standard pressure without damage to test the lumen.
  • the thickness of the 615 collapsed half (ie, collapsed), and the maximum wall thickness of the material can be collapsed without damage.
  • Pebax polyether block amide 4033 (hardness about 90 Shore A) is about 0.40 mm wall thickness; Pebax 3533 (hardness about 80-82 Shore A) It is about 0.45 mm wall thickness; Pebax 2533 (hardness about 74-77 Shore A) is about 0.50 mm wall 614 thickness; 60Shore A silicone is about 0.55 mm; 50 Shore A's silicone is about 0.60 mm wall 614 thickness.
  • the maximum wall thickness is not necessarily the material for commercialization in the future.
  • the outer diameter of the nasal irrigation catheter of the conventional manufacturing concept cannot be larger than the maximum transverse diameter of the nasal passage of 3 mm, but the present invention is a collapsible catheter and has a flat closed end 611, which is not limited by this 3 mm, and may be up to 5 mm or even larger. If the outer diameter is larger, the maximum wall thickness will also increase without damage.
  • the invention is like a microcatheter (outer diameter of 1 mm or less), it can enter the deepest part of the stenosis, so the thickness of the flat closed end 611 is not more than 1 mm, preferably not more than 0.9 mm, and it is difficult to completely collapse. Therefore, the thickness of the tube wall 614 is set to be no more than 0.45 mm.
  • the collapsible spray conduit is completely different from the general conduit.
  • the collapsibility is a special design of the nasal jet catheter 6 designed for entering the narrow slotted space. After the collapse into the narrow slotted space, the jetted water column must be pressurized and infused to restore the original state, so that the collapse and pressure perfusion can be performed. Must be considered together.
  • the catheters that are normally placed in the body are designed to have a smooth surface and a uniform size (or a tapered end), and have some degree of bending ability to accommodate the human body space. However, normal use will never allow collapse. Collapse will result in an increase in one dimension, a different outer diameter and a rough surface.
  • the function of the general catheter is drainage (the fluid flows from the human body space outside the lumen to the inside of the lumen and then out of the body in a natural state where no force is applied), and the suction (the fluid flows from the human body space outside the lumen 615 to the inside of the tube in a state of applying force) Recirculation outside the body or low pressure for the infusion fluid (the fluid flows from the lumen 615 to the human space outside the tube in a low pressure state); the function of drainage, suction or low pressure supply and delivery fluid depends on the lumen cross-sectional area, and the wall 614 collapses.
  • the other space of the human body is a closed space.
  • the catheter In addition to the nasal cavity, the other space of the human body is a closed space.
  • the catheter In addition to the nasal cavity, the other space of the human body is a closed space.
  • the catheter In addition to the nasal cavity, the other space of the human body is a closed space.
  • the catheter In addition to the nasal cavity, the other space of the human body is a closed space.
  • the catheter In addition to the nasal cavity, the catheter is used in an enclosed space. It cannot be designed with a pressurized spray function (with a small total area of the side holes).
  • the strong water column due to the pressurized spray causes the inflammatory material to flow backward. Entering the blood causes sepsis (the space that needs drainage and aspiration is inflammatory), and it is also possible that the local pressure rises instantaneously and the outer wall of the space is broken.
  • the circular shape is the same size of the two dimensions, and the flat shape is different in the size of the two dimensions, so that in addition to the two dimensions of the two dimensions, such as a triangle, Diamonds and so on are all.
  • the maximum width of the flat closed end is greater than the diameter of the catheter, in violation of the principle of uniform size or tapered end.
  • the nasal cavity of the human body is a slit-like space with a narrow front and a back width (refer to Fig. 2), the left and right widths are in mm, and the upper and lower heights are in cm, and the two dimensions are very different.
  • This special case is The other spaces in the human body are completely different. Therefore, the circular design of the catheter is unnecessary, and the ends do not need to have two dimensions that are no larger than the proximal end.
  • the flat closed end 611 is more favorable for antegrade
  • the gap-like space is described as follows:
  • the first embodiment is a 2 mm outer diameter, 1.5 mm inner diameter, and 0.25 mm tube wall 614 thickness conduit
  • the width (W) of the flat closed end 611 is the thickness of the two side walls.
  • the flat closed end 611 is more advantageous for antegrade in the slot-like space, but the flat closed end 611 is much larger than the diameter of the catheter, and the principle of conduit design that is uniform in size or tapered is only applicable to Nasal operation.
  • the width of the flat closed end 611 herein is greater than the minimum diameter of the catheter body, wherein the catheter is specifically referred to as having a circular cross-section at the end of the catheter that meets the closed end, as the catheter may taper at the end and then engage the flat closed end 611. In this case, the width of the flat closed end 611 is not necessarily greater than the maximum diameter of the catheter body 61.
  • the inventors of the present invention deeply understand the pain of patients with chronic sinusitis, but cannot obtain effective treatment. Due to the in-depth study of the characteristics of the flexible catheter, it is finally found that the collapse of the catheter and the flat closed end 611 of the unused catheter are Conducive to nasal treatment, it is worth making good use of.
  • h a gravity constant of 9.8 m/sec 2
  • t vertical.
  • the average initial velocity (V 0 ) of the water column 613 depends on the perfusion rate (IR) and the total area of the side holes (TA, Total Area).
  • the conventional catheter can only use an outer diameter of 1.25 mm through a narrow space of 1.25 mm, but the outer diameter of the catheter can be 2 mm; it is assumed that the outer diameter, the inner diameter of the catheter and the thickness of the wall 614 have the same ratio.
  • the inner diameter of the 2mm catheter is 1.6 times larger than the 1.25mm catheter, the cross-sectional area is 2.56 times larger, the flow rate and perfusion rate are increased by 2.56 times, and the vertical height of the water column is increased by 6.55 times.
  • the conventional catheter can only use an outer diameter of 1.2 mm through a narrow space of 1.2 mm, but the catheter can be used with an outer diameter of 3 mm, assuming that the outer diameter, the inner diameter of the catheter, and the thickness of the tube wall 614 also have In the same proportion, the inner diameter of the 3mm catheter is 2.5 times larger than the 1.2mm catheter, the cross-sectional area is 6.25 times larger, and the vertical height of the water column is increased by 39 times.
  • the conventional catheter can only use an outer diameter of 0.6 mm through a narrow space of 0.6 mm, but the outer diameter of the catheter can be 1.5 mm, assuming that the outer diameter, inner diameter, and wall thickness 614 of the catheter are also the same.
  • the inner diameter of the 1.5mm conduit is 2.5 times larger than the 0.6mm conduit
  • the cross-sectional area is 6.25 times larger
  • the vertical height of the water column is 39 times larger. Because the flushing effect is directly related to the vertical height of the water column, whether it is 39 times or 6.55 times is a very large difference, it will greatly improve the flushing effect.
  • the collapsed catheter may not fully recover its shape, but even so, the collapsed lumen is still larger than a conventional catheter, as explained below:
  • the outer diameter of the catheter is 2 mm
  • the inner diameter is 1.5 mm
  • the inner circumferential length L is 4.71 mm
  • the narrow space is collapsed into an ellipse having a short axis outer diameter of 1.25 mm
  • the short axis lumen diameter is 0.75.
  • the outer diameter of the catheter is 3 mm
  • the inner cavity diameter is 2.4 mm
  • the outer diameter of the catheter is 1.5 mm
  • the inner cavity diameter is 1.2 mm
  • the inner cavity circumference is 3.768 mm
  • the narrow space is collapsed to become a 0.6 mm outer diameter short axis (the short axis inner diameter is 0.3 mm, the short axis).
  • the collapsed portion of the conduit does not expand at all during the pressurized infusion, and the height of the water column can still reach 4.97 times or more, and with some degree of expansion, the water column is necessarily stronger; and this is the deepest collapse at the narrowest point.
  • the largest collapsed portion only accounts for a portion of the nasal body path of the catheter at a length of 5 cm, and the catheter is about 15 cm long, and the proportion of the collapsed portion is smaller, so the effect of the collapsed portion on the lumen flow rate is It will be smaller and the height of the water column should be stronger.
  • the nasal treatment is a daily home treatment, the equipment must be reused, and the present invention can adopt a larger diameter as described above, and can also be used with appropriate material hardness and wall thickness 614. It has better maneuverability, so it can reach the narrow space without the built-in probe. There is no problem that the probe may protrude from the tube and the patient or heavy metal is released due to repeated use.
  • the catheter Since the catheter has a collapsible and flat closed end 611, it is easy to reach the narrowest tip of the upper nasal passage and the middle nasal passage, so it is important to avoid getting into the sinus.
  • the collapsible catheter can pass through a narrow space of 0.6 mm with a sinus opening of less than 1 mm, but the width of the flat closed end 611 (2.184 mm) is much larger than 1 mm, and it is impossible to pass through the sinus.
  • the flow rate depends on the size and quantity of the side holes and the total area of the side holes, and finally the side The total area of the holes is proportional.
  • the suction of the sticky and easy to block mucus or solid material, the side hole is large and less than small and more advantageous, so the suction catheter must have a large side hole and a large side hole total area, the design principle of the side hole and the present invention
  • the nasal jet catheter 6 small and large side holes, the total area of the small side holes, inversely proportional to the square of the water column strength and the total square area of the side holes) is completely opposite.
  • the patient rinses the nasal cavity by the spray catheter, and it is impossible to confirm the position of the catheter.
  • the high-pressure perfusion solution must be flushed with a strong slender water column. Because the nasal cavity is open space, it is more rushed. The lotion will be lost immediately, and there will be no problem, but if it accidentally enters the sinus, because the sinus is closed space, and the outlet has been plugged by the catheter, a large amount of perfusion irrigation fluid can not be discharged, may cause acute sinusitis, and the high pressure water column is more May cause inflammatory substances to flow back into the bloodstream to cause sepsis, and may even be too much pressure, causing the sinus to rupture, affecting the adjacent meninges, and producing meningitis.
  • the traditional rounded closed end may cause accidental entry into the sinuses, causing serious complications, and is a dangerous design.
  • the catheter provider must be responsible, which is why our previous case has not been commercialized.
  • the maximum width of the flat closed end 611 of the present invention is not less than 1 mm, preferably not less than 1.2 mm, or 1.5 mm, or 2 mm, or more.
  • the material of the catheter can reach 90-100 Shore A, the harder the material can be collapsed, the thinner the wall thickness is, the thinner the wall thickness can be collapsed, the flat closed end must not be too hard, and it can be made into a smooth arc shape. Still will not hurt the patient.
  • the appropriate collapsible material and the thickness of the wall 614 can be selected, that is, the large catheter can reach the narrow space above the nasal cavity by the far water column.
  • the nasal cavity of the human body is divided into three slightly curved slit passages by three plate-like structures, namely the upper turbinate F, the middle turbinate G, and the inferior turbinate H, and three
  • the passage is the upper nasal passage F1, the middle nasal passage G1, and the lower nasal passage H1.
  • the lining space D can be divided into the upper middle space D1, the middle middle space D2, and the lower middle. ⁇ Space D3.
  • Figure 12 is a coronal cross-sectional view of the posterior part of the nasal cavity, showing that all nasal passages F1, G1, and H1 are in a wide and narrow curved condition.
  • the middle nasal passage is even divided into a descending section B1D of about 2 m in height (mucus from above) And the lower part and the horizontal section B1H of the length of about 1cm. All of the above narrowing of the air passage is caused by the adhesion of the knots over the years.
  • the high-pressure conduit body 61 capable of ejecting a large outer diameter of the strong water column can only be placed in the wide horizontal section B1H (shown in Figure 12), because the water column cannot turn to reach the falling section B1D, so the effect is not good;
  • the small conduit of the built-in probe of the case can reach the descending section, but the water column is weakly inefficient; however, the collapsible catheter body 61 of the present invention having a size comparable to that of the high-pressure catheter of the previous case can be placed in the narrow descending section B1D ( Shown in Figure 13), the best rinsing effect is obtained as described above.
  • the catheter can reach the upper middle space without close to the nose.
  • D1 see Figure 14
  • F1 the adjacent upper nasal passage F1
  • it is also easy to reach the narrow descending section B1D of the middle nasal passage G1 slightly upwards and outwards (Fig. 13). It is indeed possible to flush the small gap space with a large duct.
  • the present invention capable of collapsing the catheter body 61 placed above the narrow descending section B1D, because the strong water column directly sprays the adjacent crucible vertically, the required penetration and peeling is only the crustal thickness calculated in mm, so the effect is remarkable.
  • the collapsible catheter body 61 of the present invention placed in the upper middle space D1 (see FIG. 14) and the upper nasal passage F1 (see FIG. 15) can also vertically spray adjacent adjacent knots in mm.
  • the upper nasal passage F1 is narrow, the mucus is likely to cause obstruction, the air cannot circulate, the mucus remains liquid due to lack of drying, and it is easy to flow back to the top of the upper nasal passage F1 and the nasopharynx J. Junction.
  • the mucus of the middle nasal passage G1 also flows into the nasopharynx, but the middle nasal passage G1 is wider than the upper nasal passage F1, and the mucus mostly falls into a thin layer, which is easily dried by the influent air into a solid crusted. Only a small part of the flow to the nasopharynx J.
  • the mucus that flows down into the nasopharynx J mainly comes from the upper nasal passage F1. Therefore, the mucus of the nasopharynx J is flushed directly to the top of the nasopharynx J via the upper nasal passage F1 and then washed with a strong water column to obtain the best effect, but the sinusoidal sinus has an opening at the top of the nasopharynx J, only the invention can reach For this purpose and to avoid getting into the sphenoid sinus.
  • the collapsible nasal cavity ejection catheter 6 of the present invention does have the following effects: by the flat closed end 611 and the collapsible catheter body 61 characteristics, the larger catheter can be drilled deep into the narrow The goal is to spray a long, strong or large number of slender water column for better irrigation purposes and to avoid the risk of accidental entry into the sinus. It is also possible to eliminate the width of the nasal passage and the upper nasal passage by computerized tomography. The trouble of selecting an appropriately sized catheter is truly effective and convenient.
  • the collapsible nasal cavity ejection catheter 6 of the invention can overcome the disadvantage that the conventional nasal catheter is difficult to completely wash the deep cavity of the nasal cavity, can truly improve the symptoms of the patient with chronic sinusitis, and reduce the discomfort during use, facilitating the patient to go out for use. .

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Abstract

一种以热塑性弹性体或其他柔软具弹性的材质制成的可塌陷鼻腔喷射导管（6），可供病人自行操作置入鼻腔及鼻咽（J）。该导管（6）包括一导管本体（61）及一衔接器（62）。该导管本体（61）具一扁平状封闭末端（611）及一相反于该封闭末端（611）的开放端（612），并于接近该封闭末端（611）处开设多个边孔（163），如配合一衔接器（62）及一注射筒（7）可在鼻腔及鼻咽（J）喷出多重强劲细长水柱以清洗粘液及结痂。该导管本体（61）的扁平状封闭末端（611）的最大宽度不小于1mm且其管壁（614）最小厚度不大于0.45mm。因为导管本体（61）的扁平状封闭末端（611）及可塌陷性，使较大外径的导管（6）可顺行于隙缝状空间，抵达狭窄的深处产生较佳的冲洗效果，也可以避免误入鼻窦。

Description

可塌陷鼻腔喷射导管 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深处及鼻咽清洗粘稠分泌物，以改善慢性鼻窦炎症状的可塌陷鼻腔喷射导管。
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，其症状包含鼻塞、喉咙异物感及咳嗽等症状会持续困扰病人，甚至一生。抗生素只是对急性感染的治疗，而外科手术的目的是移除阻塞或扩大鼻腔内通路以改善粘液的排放，并避免鼻窦炎急性发作。不管做何治疗，疾病的机转并未改变，症状仍然存在，因此，耳鼻喉科医师均建议辅以湿润鼻腔的长期居家治疗，一般建议每天至少湿润鼻腔两次，因为无法治愈需要终生居家治疗。(Wikipedia，key word:chronic sinusitis，Medscape,Treatment，Long-term monitoring)
参阅图1、2，为人体鼻腔内的矢状剖面与冠状剖面视图，与鼻子的外观相似，鼻腔正面呈现上窄下宽的三角形，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稍微弯曲的隙缝状通路，及一个临中膈空间。此三片由上向下渐大的板状结构称为上鼻甲A、中鼻甲B，及下鼻甲C，而三个由上向下渐大的通路则为上鼻通道A1、中鼻通道B1及下鼻通道C1。中鼻通道常分为约2cm的下降段(B1D)及约1cm的水平段(B1H)两段。临中膈空间以上、中、下鼻甲A、B、C下缘区分为上、中、下临中膈空间D1、D2、D3。鼻腔本体前后径约5cm，中鼻甲B、及下鼻甲C、中鼻通道B1及下鼻通道C1均5cm；而上鼻甲A及上鼻通道A1只占鼻腔本体后半部，前后径约2.5cm。三个鼻甲，鼻中膈及鼻腔侧壁均由骨胳构成骨架，表面再覆被粘膜，以此增加表面积使鼻腔本体的空间成为隙缝状通路并具有两个功能:1.调整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。所有粘液都由鼻腔旁边及上面的四对鼻窦(上颌窦、前额窦、筛状窦、蝶状窦)分泌，并从位于上鼻通道A1(筛状窦后三分之一)、中鼻通道B1(上颌窦、前额窦及筛状窦前三分之二)及鼻咽顶部(蝶状窦)的几个圆形细小开口(通常1mm或更小)排出。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，鼻水是不含粘液的液体会完全蒸发；接下来是容易排出稍具粘性的鼻涕；再来是不易排出且呈浓稠状的粘液；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，这是粘液的四种型态。慢性鼻窦炎就是粘液及鼻屎堆积在鼻腔本体所造成的症状。感冒症状不会超过4星期，慢性鼻窦炎则是不知病因却不断分泌粘液的疾病，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，但必定有大量的鼻水，也不会有喉咙异物感，只要过敏原消失就会恢复正常，是间断性发作周期性或季节性的疾病，而慢性鼻窦炎的症状是鼻水太少粘液太粘所造成，其症状是经年累月永远困扰病人。
配合参阅图3，慢性鼻窦炎病患的分泌物，因过于粘稠，无论是用力擤鼻涕，或是用力抽吸都很难完全移除。粘液容易粘附在狭窄空间造成局部阻塞，阻塞则无空气经过因而少接触空气而保持液态，但如重力超过附着力，则依病人的姿势顺着重力向前向下或向后较宽处移动，向前滑入鼻前庭90或向下流入下方较大的空间成为习知的鼻涕，更进一步干化成为鼻屎；也会向后滑入鼻咽91，此即习知的粘液倒流，也很难用抽吸或吞咽的动作来清除。未能移除而滞留在鼻腔的粘液不像鼻水会蒸发消失，如滑入较大的空间则成为薄层，因未完全阻塞会受呼吸空气的干化缩小体积，一层一层粘附于鼻腔内并自位于中鼻通道B1及上鼻通道A1的鼻窦开口处向外漫延，终于造成持续且严重的鼻塞。粘液继续从上鼻通道及中鼻通道的开口排出，形成悬吊于鼻腔上方的状态，而粘液的最前端即其最下部份因仍与空气接触，反而成为最坚硬的鼻屎状态。流入鼻咽的粘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，流入其内的粘液干化速度更快，不管是液态的粘液或固态的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，粘液及鼻屎终将阻塞鼻窦出口，造成粘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，持续分泌粘液仍然不变，症状仍然存在。
体外实验可观察到，粘液四种型态的互相改变，鼻涕暴露在空气中可成为粘液，粘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，半鼻屎可成为粘液，时间更久之后可成为鼻涕。因此湿润鼻腔做为慢性鼻窦炎的辅助治疗，听起来相当合理，但如图1、2、3所示，鼻腔本体是三个鼻通道及一个临中膈空间所构成狭窄隙缝状的复杂结构，并非是空无一物的空洞空间。鼻腔本体可从鼻前庭90到体外，也可以从鼻咽到口腔再到体外，更是人体内独一无二前后都通到体外的开放空间(口腔也是开放空间，但是有肌肉群可以自主运动，是属于可以打开及关闭的空洞空间)。从外部灌注冲洗液，必定先从前后泄漏出去，而且因为鼻甲的阻隔，不管用何种姿势都无法充满整个鼻腔本体，而且湿润不一定能清除粘液，湿润鼻腔说起来 容易，但清除粘液却困难重重。
再以下列实验模拟冲洗鼻腔的机制如下：以水平水柱喷射粘附于直立塑胶板的粘液、半鼻屎及鼻屎，水柱强度再依垂直向上的长度区分为：45cm以下的低压水柱，45cm至90cm的中压水柱及90cm以上的高压水柱。如此可以观察到：低压水柱能使粘液变成稀薄的鼻涕，也能使半鼻屎表面变成粘液，但无法改变坚硬的鼻屎；中压水柱可使粘液及半鼻屎变成易于流动的鼻涕，也可使坚硬的鼻屎表面变成浓稠的粘液；高压水柱则可使坚硬的鼻屎直接剥离滑落，半鼻屎粘液及鼻涕更容易被直接冲走。因此，冲洗效果与水柱垂直高度直接相关。
参阅图4、5，为中国台湾发明第I542371号专利，此专利文件是申请人所申请的前案(以下简称前案)，其目的是改善原鼻腔冲洗导管发明第I515025号专利的缺点。其改善方法为：1.以边孔总面积控制水柱高度，并以水柱高度区分为高压、中压，及低压导管611，但高压导管611必需使用较大较耐压的导管611，此高压导管611虽能清除大部份结痂及粘液改善鼻塞症状，但无法抵达较深较狭窄的处，更细更多的小水柱虽增加对正隙缝状空间的机会，效果仍未完全满意；2.以管腔内留置探针8改善微导管的操控性，但微导管611水柱弱冲洗效率差，而且实际制造1mm外径的导管已经不易，但严重病人的鼻腔狭窄处甚至小至0.5mm，更难深入；而且微导管也有误入鼻窦的危险。另外亲友使用的经验，鼻塞症状虽可立即改善，但喉咙异物感及咳嗽仍未能持续改善达到理想的状况，而且大小两种导管必需搭配使用，甚至需要电脑断层摄影测量中鼻通道及上鼻通道的宽度以选取适当的导管，仍觉不便，仍有持续改善的必要。
以上是我们尚未公开的人体试验经验，尤其是病人自己操作可能误入鼻窦，是不可能凭空想象的。对其他人而言，在本发明申请日以前，没有任何人会在没有专利在手的前题下研究此案；即使认真研究也会发现前案非常合理，难以找到缺点，而如认为前案疗效不佳，也正好证明全世界医学专家的共识确有道理(Wikipedia,key word:chronic sinusitis,Medscape Reference；Wikipedia,keyword:chronic sinusitis Mayo Clinic；Wikipedia,keyword:sinusitis,University of Maryland Medical Center-sinusitis,page 11-12)：冲鼻治疗无效时要考虑开刀的建议，难以摆脱医学专家权威式的影响力；另外前案尚未商品化，无法做人体试验，不可能发现此案的缺点。因此改善此案以造福病人，我们责无旁贷。因为我们身兼医师、病人及技术领域业者三种角色，经过两年的在亲友之间不断试验，才能完成本发明。
技术问题
本发明所要解决的技术问题是：现有技术中的鼻腔冲洗导管在使用上的不便利性。
技术解决方案
有鉴于此，本发明的目的是在设计一种有效又易于操作的导管，具体而言是设计一种可以 喷射强劲水柱，可以深入狭窄的隙缝状空间，又不会误入鼻窦的多功能导管。
本发明的手段是在提供一种可塌陷的鼻腔喷射导管，可配合一注射筒灌注冲洗液以冲洗鼻腔及鼻咽；该导管包含一导管本体及一衔接器，该导管本体具有一扁平状封闭末端及一相反于该扁平状封闭末端的开放端，且靠近该扁平状封闭末端处形成有多个边孔；该导管本体是以热塑性弹性体或其他柔软具弹性的材质制成，可供病人自行操作置入鼻腔及鼻咽，其特征在于：该导管本体的最小管壁厚度不大于0.45mm，且该扁平状封闭末端的最大宽度不小于1mm。
本发明的另一技术手段，是在于上述扁平状封闭末端的最大宽度大于该导管本体的最小直径。
本发明的再一技术手段，是在于上述的导管的硬度介于80Shore A以下，管壁厚度不大于0.45mm。
本发明的另一技术手段，是在于上述的导管的硬度介于80～90Shore A，管壁厚度不大于0.40mm。
本发明的又一技术手段，是在于上述的导管的硬度在90Shore A以上，管壁厚度不大于0.35mm。
有益效果
本发明的有益功效在于，该导管的扁平状封闭末端及可塌陷性使其易于顺行于鼻腔内的隙缝状空间，进入远小于导管外径的狭窄空间，并喷出较强劲细长水柱，达到更佳的冲洗目的，而且可以避免误入鼻窦。
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a-a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粘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，说明中国台湾发明第I542371号的「鼻腔冲洗导管」；
图5是一局部剖视示意图，说明中国台湾发明第I542371号的「鼻腔冲洗导管」的衔接器与导管本体的衔接态样，以及探针的安全设计；
图6是一立体分解示意图，说明本发明鼻腔喷射导管的组成；
图7是一截面示意图，说明本发明的导管本体的自然状态；
图8是一截面示意图，说明本发明的导管本体的塌陷状态；
图9是一局部剖视示意图，说明本发明导管本体末端及扁平状封闭末端的态样；
图10是图9中线段b-b的截面示意图；
图11是图9中线段c-c的截面示意图；
图12是一鼻腔后半部的冠状剖面视图，说明发明第I542371号的高压导管只能放在中鼻通道的水平段的态样；
图13是一鼻腔后半部的冠状剖面视图，说明本发明的可塌陷鼻腔喷射导管可以置入中鼻通道的下降段的态样；
图14是一鼻腔后半部的冠状剖面视图，说明本发明的可塌陷鼻腔喷射导管可以置入上临中膈空间的态样；
图15是一鼻腔后半部的冠状剖面视图，说明本发明的可塌陷鼻腔喷射导管可以置入上鼻通道的态样；及
图16是人体鼻腔内的矢状剖面视图，说明本发明的可塌陷鼻腔喷射导管可以经由上鼻通道进入鼻咽进行冲洗的态样。
【符号说明】
B1D  下降段；
B1H  水平段；
D   临中膈空间；
D1  上临中膈空间；
D2  中临中膈空间；
D3  下临中膈空间；
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；
J   鼻咽；
6   鼻腔喷射导管；
61  导管本体；
611 封闭末端；
612 开放端；
613 边孔；
614 管壁；
615 管腔；
62  衔接器；
7   注射筒；
71  容置件；
72  挤压件。
本发明的实施方式
有关本发明的相关申请专利特色与技术内容，在以下配合参考图式的三个较佳实施例的详细说明中，将可清楚地呈现。
在进行详细说明之前，值得一提的是，类似的元件是以相同的元件编号来作表示，且以下仅先就元件的构成及连接关系作各个实施例的介绍说明，至于详细的制程参数、使用操作过程，及功效说明则叙述于后。
参阅图6，为本发明可塌陷鼻腔喷射导管6，其可配合一注射筒7灌注冲洗液以冲洗人体的鼻腔及鼻咽。
该可塌陷鼻腔喷射导管6包含一导管本体61及一衔接器62，该导管本体61是以热塑性弹性体或其他柔软具弹性的材质制成，可供病人自行操作置入鼻腔及鼻咽中，该导管本体61具有一扁平状封闭末端611及一相反于该扁平状封闭末端611的开放端612，且该导管本体61上靠近该扁平状封闭末端611处形成有多个边孔613。
该注射筒7具有一容置件71，及一设置于该容置件71内的挤压件72，该容置件71内可盛装液体，该挤压件72将容至于该挤压件72的液体挤入该导管本体61中，再借由压力由该多个边孔613向外喷出。
该衔接器62的一端是连接该导管本体61的开放端612，另一端是连接该注射筒7，以使该注射筒7中的液体输送至该导管本体61中。
参阅图7、8，为该导管本体61的截面图，该导管本体61是由一管壁614，及由该管壁614围绕界定出的一管腔615，可以盛装液体并供冲洗液体通过。
该管壁614是由柔软且具弹性的材质所制成，因此自然状态下该管壁614形成正圆(如图7所示)。但由该管壁614外界施与一外力后(图7、8中未显示)，该管壁614将塌陷并形成椭圆(如图8所示)。
配合参阅图9、10、11，为该导管本体61的封闭末端611的剖视图，该导管本体61上的多个 边孔613。
其中，线段b-b为设置多个边孔613的区域，当该导管本体61内的液体压力大于外界，液体将会从该多个边孔613向外喷出，线段c-c为该导管本体61的扁平状封闭末端611，是以热融、粘胶或其他方法将该导管本体61压扁封闭。接近扁平状封闭末端611的导管本体61必定成为椭圆形再逐渐过渡至导管原来的圆形。椭圆形的长径必大于圆形的直径，椭圆形的短径必小于圆形的直径。此过渡长度依材质硬度、管壁厚度及导管内外径而定。
本导管的特征为：
1.可塌陷性，及；
2.扁平状封闭末端。
第1特征：可塌陷性。以弹性材质制造的导管遇压力会变形，压力解除则恢复原形，压力越大变形越大，但外径越小、材质越硬及管壁614厚度越大，其抵抗变形能力也越大，反之亦然。而越接近完全塌陷变形所需的压力大增，因此管腔615塌陷一半的效率最佳，所以定义管腔615塌陷一半为可塌陷。导管61与鼻腔粘膜互相挤压，在未引起痛觉而管腔615塌陷一半称为无伤害可塌陷。在耳鼻喉科领域，以纱布或填塞装置(packing device)填塞鼻腔做为止血的手段是众所周知，医学文献也多有填塞压力不可过高的建议，却查不到确切的压力数值，但同属呼吸系统的气管则有不少研究报告提到确切数值，这些报告都建议气管内管挤压气管的压力(cuff pressure of endotracheal tube)不可超过30mmHg＝40.8cmH2O，主要考量气管内管需使用连续数天或更久，如压力太大，容易引起气管坏死等并发症，因此我们采用此为无伤害标准压力。二年多来我们一直以前案的高压喷射导管用于冲鼻治疗，并未有鼻腔特别疼痛的问题或鼻腔粘膜坏死的并发症，我们曾以压力计测量前案的高压喷射导管在高压灌注时的管腔压力，所得结果为1～4大气压，瞬间甚至可达5大气压，此压力虽不一定在整个冲鼻治疗过程都直接施压于鼻腔粘膜，但仍可证明冲鼻治疗中鼻腔粘膜的耐压应大于气管的耐压数值(40.8cmH2O)。因正常人中鼻通道及下鼻通道最宽约为3mm，因此设定外径3mm为标准导管尺寸，再以无伤害标准压力施压于各种硬度材质的标准尺寸导管，以测试其管腔615塌陷一半(即可塌陷)的厚度，求取此材质的无伤害可塌陷最大管壁厚度。以下是实验所得各种硬度材质的无伤害可塌陷最大管壁614厚度：Pebax(polyether block amide)4033(硬度约90Shore A)为约0.40mm管壁厚度；Pebax 3533(硬度约80～82Shore A)约为0.45mm管壁厚度；Pebax 2533(硬度约74～77Shore A)约为0.50mm管壁614厚度；60Shore A的silicone约为0.55mm；50Shore A的silicone约为0.60mm管壁614厚度。
因为符合条件的材质很多，无法一一试验，以上只是较易取得的材质，以测试各种硬度的可塌 陷最大管壁厚度，不一定是日后商品化的材质。传统制造概念的鼻腔冲洗导管的外径不能大于鼻通道3mm的最大横径，但本发明是可塌陷导管又具有扁平状封闭末端611，不受此3mm的限制，也许可达5mm，甚至更大，外径如更大，无伤害可塌陷最大管壁厚度也会增大。
因本发明是要像微导管(外径1mm以下)一样可以进入狭窄的最深处，因此扁平状封闭末端611的厚度以不大于1mm为原则，较佳为不大于0.9mm，又考量完全塌陷不易，因此管壁614厚度设定为不大于0.45mm。
可塌陷喷射导管与一般导管完全不同。可塌陷性是专为进入狭窄隙缝状空间的鼻腔喷射导管6的特殊设计，塌陷进入狭窄隙缝状空间的后要喷射水柱必经加压灌注使其恢复原状的过程，因此可塌陷与加压灌注必需一起考量。除了直接开刀置入体内的导管以外，一般由体外置入体内的导管的设计均以表面平滑及大小均一(或末端渐细)为原则，为适应人体空间虽都有某种程度的弯曲能力，但正常使用情况绝不允许塌陷，塌陷会造成一个面向(one dimension)增大、外径大小不一及表面粗糙的结果，违反表面平滑及大小均一(或末端渐细)的原则，由体外置入体内或由体内拔除，都会伤害组织，完全违反最小伤害原则。另外，一般导管的功能为引流(流体在不施力的自然状态从管腔外的人体空间流向管内再流出体外)、抽吸(流体在施力的状态从管腔615外的人体空间流向管内再流出体外)或低压供输流体(流体在低压状态从管腔615内流向管外的人体空间)；引流、抽吸或低压供输流体功能都取决于管腔截面积，管壁614塌陷会妨碍引流、抽吸或低压供输功能，违反一般导管的设计原理。除鼻腔外人体的其他空间都是封闭空间，一般导管都使用在封闭空间，不能设计具有加压喷射功能(具有较小的边孔总面积)，因加压喷射的强劲水柱会造成发炎物质逆流进入血液造成败血症(需要引流、抽吸的空间都有发炎现象)，也可能局部压力瞬间上升导致空间外壁破裂。而可塌陷导管供输液体必经加压灌注使其恢复原状的过程，此恢复原状的过程难以控制压力，会瞬间增压产生强劲水柱，因此可塌陷导管可能产生以上的副作用，不能用于封闭空间，只适用于鼻腔的冲鼻治疗，也与其他导管不同。
第2特征：扁平状封闭末端611。非圆即扁，圆形是两个面向(two dimensions)大小相同，而扁平状则两个面向(two dimensions)大小不同，因此除两个面向(two dimensions)大小相同的圆形外例如三角形、菱形等皆属的。扁平状封闭末端的最大宽度大于导管直径，违反大小均一或末端渐细的原则。但人体的鼻腔是前后走向上窄下宽的隙缝状空间(参考图2)，左右宽度以mm计，而上下高度则以cm计，两个面向(two dimensions)差异非常大，此特殊情形与人体内其他空间完全不同，因此，导管的圆形设计成已非必要，末端也不必两个面向(two dimensions)都不大于近端，相反地，扁平状封闭未端611更有利于顺行于隙缝状空间，兹说明如下：
导管的横断面为圆形，其外圆周长(Outer Circumference)等于外径(Outer Diameter)×圆周率，等式 为OC＝OD×3.14；内腔圆周长(Inner Circumference)等于内径(Inner diameter)×圆周率，等式为IC＝ID×3.14。
举例而言，第一实施例(图9、10、11)是2mm外径、1.5mm内径及0.25mm管壁614厚度的导管，其扁平状封闭末端611的宽度(W)为两边管壁厚度(t)加内腔圆周塌陷后的宽度，等式为W＝2t+ID×3.14/2，数值为W＝0.5+1.5×3.14/2＝2.855mm，宽度远大于直径2mm，但厚度只有0.5mm；如管腔615塌陷一半，则2mm的导管可穿过1.25mm＝2-(1.5/2)mm的狭窄空间。
第二实施例是3mm外径、2.4mm内径及0.3mm管壁614厚度的导管，其扁平状封闭末端611的宽度为0.6+2.4×3.14/2＝4.368mm，仍远大于直径3mm，但厚度只有0.6mm；如管腔615塌陷3/4(管径越大遇压塌陷越大)，则3mm的导管可穿过1.2mm＝3-(2.4×3/4)mm的狭窄空间。
第三实施例是1.5mm外径、1.2mm内径及0.15mm管壁614厚度的导管，其扁平状封闭末端611的宽度为0.3+1.2×3.14/2＝2.184mm，也远大于直径1.5mm，但厚度只有0.3mm；如管腔615塌陷3/4，则1.5mm的导管可穿过0.6mm＝1.5-0.9mm的狭窄空间。
此三个实施例均证明扁平状封闭未端611更有利于顺行于隙缝状空间，但扁平状封闭末端611远大于导管直径，违反大小均一或末端渐细的导管设计原则，只适用于在鼻腔的操作。此处所述扁平状封闭末端611的宽度大于导管本体的最小直径，其中导管专指与封闭末端相接的导管末端具有圆形截面的处，因导管可能末端渐细再衔接扁平状封闭末端611，此种情况，扁平状封闭末端611的宽度不一定大于导管本体61的最大直径。
本发明发明人深深体会慢性鼻窦炎病人的痛苦，却无法得到有效的治疗，因深入研究弹性导管的特性，终于发现技术领域业者所舍弃不用的导管的塌陷性及扁平状封闭末端611反而有利于冲鼻治疗，值得善加利用。
本发明的特殊设计在功能上所产生的差别可以说明如下：
因为边孔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，又最高垂直顶点为h，则h＝1/2(gt2)，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)取决于灌注速度(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，因此水柱垂直高度与灌注速度的平方成正比，灌注速度虽与外部施压有关，但仍受限于管腔流速，而管腔615流速受限于与管腔615截面积且与其成正比，因此水柱垂直高度与管腔615截面积的平方成正比。
在第一实施例中，穿过1.25mm的狭窄空间，传统导管只能用1.25mm外径，但本导管可用2mm外径；假设导管的外径、内径及管壁614厚度均具有相同比例，则2mm导管的内径比1.25mm导管大1.6倍，截面积大2.56倍，流速与灌注速度增2.56倍，水柱垂直高度增6.55倍。
在第二实施例中，同样地，穿过1.2mm的狭窄空间，传统导管只能用1.2mm外径，但本导管可用3mm外径，假设导管的外径、内径及管壁614厚度也具有相同比例，则3mm导管的内径比1.2mm导管大2.5倍，截面积大6.25倍，水柱垂直高度增39倍。
在第三实施例中，穿过0.6mm的狭窄空间，传统导管只能用0.6mm外径，但本导管可用1.5mm外径，假设导管的外径、内径及管壁614厚度也都具有相同比例，则1.5mm导管的内径比0.6mm导管大2.5倍，截面积大6.25倍，水柱垂直高度大39倍。因为冲洗效果与水柱垂直高度直接相关，不管39倍还是6.55倍都是非常巨大的差异，都会巨大地善冲洗效果。
在狭窄空间，已塌陷的本导管可能无法完全恢复圆形，但即使如此，塌陷的管腔截面积仍比传统导管大，兹说明如下：
圆周的计算公式为C＝3.14×R，其中C为圆周，R为圆的直径；圆面积的计算公式为S＝0.785×R2；椭圆周长的计算公式为L＝2πb+4(a-b)，其中a为长轴半径，b为短轴半径，此公式可改写为a＝(L+4b-2πb)/4；椭圆面积的计算公式为S＝πab；π为圆周率3.14。
在第一实施例中，本导管外径为2mm，内径为1.5mm，内腔圆周长L为4.71mm，在狭窄空间塌陷成为短轴外径1.25mm的椭圆，其短轴内腔直径为0.75mm，短轴内腔半径b＝0.375mm，则其长轴内腔半径a＝(L+4b-2πb)/4＝(4.71+1.5-2.355)/4＝1.34mm，此椭圆内腔截面积为S＝3.14×a×b＝3.14×1.34×0.375＝1.57785mm2。与本导管相对应的外径1.25mm传统导管如与具有相同比例的外径及管壁，则其内腔直径为1.25mm×0.75＝0.9375mm，其内腔截面积为S＝0.9375×0.9375×0.785＝0.6899mm2。两相比较，本导管塌陷后内腔截面积与传统导管之比为1.57785/0.6899＝2.287倍，水柱高度仍可达2.287×2.287＝5.23倍。
在第二实施例中，本导管外径为3mm，内腔直径为2.4mm，内腔圆周长L＝3.14×2.4＝7.536mm，在狭窄空间塌陷成为1.2mm外径短轴(短轴内腔直径0.6mm，短轴内腔半径b＝0.3mm)的椭圆，则其长轴内腔半径为a＝(L+4b-2πb)/4＝(7.536+1.2-2×3.14×0.3)/4＝1.713mm，而椭圆内腔截面积为S＝3.14×a×b＝3.14×a×b＝3.14×1.713×0.3＝1.6136mm2。与本导管相对应的外径1.2mm传统导管如与具有相同比例的外径及管壁，则其内腔直径为1.2mm×0.8＝0.96mm，其内腔截面积为S＝0.9375×0.9375×0.785＝0.7234mm2。两相比较，本导管塌陷后内腔截面积与传统导管的比为1.713/0.7234＝2.23倍，水柱高度仍可达2.23×2.23＝4.97倍。
在第三实施例中，本导管外径为1.5mm，内腔直径为1.2mm，内腔圆周长为3.768mm，在狭 窄空间塌陷成为0.6mm外径短轴(短轴内径0.3mm，短轴内腔半径b＝0.15mm)的椭圆，则其长轴内腔半径a＝(L+4b-2πb)/4＝(3.768+4×0.15-2×3.14×0.15)/4＝0.8565mm，而椭圆内腔截面积为S＝3.14×a×b＝3.14×0.8565×0.15＝0.4034mm2。与本导管相对应的外径0.6mm传统导管如与具有相同比例的外径及管壁，则其内腔直径为0.6mm×0.8＝0.48mm，其内腔截面积为S＝0.48×0.48×0.785＝0.180864mm2。两相比较，本导管塌陷后内腔截面积与传统导管的比为0.4034/0.180864＝2.23倍，水柱高度仍可达2.23×2.23＝4.97倍。
本导管的塌陷部份即使在加压灌注中完全不膨胀，水柱高度仍可达4.97倍以上，再加上某种程度的膨胀，水柱必然更强；而且这是计算最狭窄处最深处的塌陷状况，此最大塌陷部份只占导管在5cm的长度的鼻腔本体路径中的一部份，而导管约长15cm，塌陷部份所占比率更小，因此塌陷部份对管腔流速的影响还会更小，水柱高度应会更强。
结论：本发明的特殊设计会巨大地善冲洗效果。
本发明其他优点及考量：因冲鼻治疗属每天执行的居家治疗，器材必需重复使用，而本发明如前所述可采用较大管径，也可配合使用适当的材质硬度及管壁614厚度得到较佳的操控性，因此不需内置探针就可抵达狭窄空间，没有因重复使用致探针可能突出管外伤及病人或重金属释出等问题。
本导管因具有可塌陷性及扁平状封闭末端611，很容易抵达上鼻通道及中鼻通道的最狭窄的顶端，因此避免误入鼻窦就显得很重要。例如第三实施例，1.5mm导管，可塌陷导管可穿过小于1mm鼻窦开口的0.6mm的狭窄空间，但扁平状封闭末端611的宽度(2.184mm)却远大于1mm，不可能穿过鼻窦约1mm圆形的开口，因而足以避免误入鼻窦；相反地，传统的导管，如果可以进入1mm的狭窄空间，则其圆形封闭末端必不大于1mm，就可能意外进入鼻窦，而进入鼻窦并非冲洗鼻腔的目的，其后果说明如下。
以导管进入鼻窦，并以冲洗液冲洗是医师在开刀中治疗鼻窦炎的方法，此开刀方法必需内视镜及X光透视引导并确认进入鼻窦。这是非常专业的开刀技术，医师必需经过特殊训练，进入鼻窦不易不难想象。既已进入，必须一次清除鼻窦内的粘液及发炎物质，否则有开刀失败的风险，因此必须使用抽吸功能良好的导管。所谓抽吸是指流体在加力状态下自管外流向管内，而抽吸功能是指流体自管外流向管内的流速，此流速取决于边孔大小、数量及边孔总面积，最终与边孔总面积成正比。而抽吸粘稠易阻塞的粘液或固态物质，边孔大而少比小而多有利，因此抽吸导管必定具有大的边孔及大的边孔总面积，此边孔设计原理与本发明的鼻腔喷射导管6(边孔小而多，小的边孔总面积，因水柱强度与边孔总面积的平方成反比)完全相反。病人以喷射导管自行冲洗鼻腔，完全无法确认导管所在位置，但必定高压灌注大量冲洗液以强劲细长水柱冲洗，因鼻腔是开放空间，再多冲 洗液也会马上流失，不会有任何问题，但如意外进入鼻窦，因鼻窦是封闭空间，而且出口已被导管塞住，大量灌注冲洗液无法排出，可能引发急性鼻窦炎，而且高压水柱更可能导致发炎物质逆流进入血液造成败血症，甚至可能瞬间压力太大，导致鼻窦破裂，波及邻近的脑膜，产生脑膜炎。
因此传统的圆形封闭末端可能导致意外进入鼻窦，引起严重的并发症，是很危险的设计，导管提供者必须负责，这也是我们的前案迟未商品化的原因。为了避免误入鼻窦，本发明扁平状封闭末端611的最大宽度以不小于1mm为原则，较佳为不小于1.2mm，或1.5mm，或2mm，或更大。
导管的材质虽可达90-100Shore A，但越硬材质无伤害可塌陷最大管壁厚度越薄，既可塌陷，扁平状封闭末端必不会太硬，也可制成平顺的圆弧状，仍不会伤害病人。
因此，选用适当的可塌陷的材质及管壁614厚度，即可以较大导管达到远为强劲的水柱冲洗鼻腔上方狭窄的空间的目的。
因为手工制造的前案导管，在专利申请前已亲身试用，至今已逾二年，而且本发明的导管也试用近半年，因此我们有机会比较不同导管的差异，也了解病人的感受，病人可以接受每天清洗鼻腔的恼人工作，只要症状获得足够的改善。
参阅图12～15，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。因为鼻腔是左、右对称，在鼻腔近中央处即称为临中膈空间D，该临中膈空间D又可区分为上临中膈空间D1、中临中膈空间D2，及下临中膈空间D3。图12～15为鼻腔后半部的冠状剖面视图，说明所有鼻通道F1、G1、H1都呈上狭下宽弯曲的状况，中鼻通道甚至分为约2m高度的下降段B1D(粘液由上而下)及1cm左右长度的水平段B1H两段。所有以上所述空气通路的狭窄都是结痂经年累月一层一层粘附所造成。
能喷出强劲水柱外径较大的前案高压导管本体61只能放在较宽的水平段B1H(显示于图12)，因水柱不能转弯抵达下降段B1D，因而效果不佳；如使用前案的内置探针的细小导管，虽可抵达下降段，但因水柱弱效率差；但使用尺寸与前案高压导管相当的本发明可塌陷导管本体61，却可放置于狭窄的下降段B1D(显示于图13)，如上所述可得到最佳的冲洗效果。因本发明兼具微导管的细小及大导管的操控性的优点，实际操作时，在扁平状封闭末端611的前导下，导管如紧贴鼻中膈向上向后即可抵达上临中膈空间D1(参阅图14)或临近的上鼻通道F1(参阅图15)；如稍向上向外向后也很容易抵达中鼻通道G1的狭窄下降段B1D(图13)。确实可达到以大导管冲洗小隙缝状空间的目的。
前案高压导管本体61即使能勉强放置在下降段B1D的下方，强劲细长的水柱也能对正隙缝向上喷射，但平行的向量等于零，平行于隙缝状的水柱无法剥离下降段B1D上下2cm长度的结痂， 只具有湿润结痂的效应。但结痂吸水膨胀，已经狭窄的空间变成完全阻塞，症状反而加重。传统冲鼻器由前向后单一方向的水柱如用于这种鼻腔通路狭窄的病人也无法剥离鼻腔本体5cm长度前后径的结痂，同样反而加重病情，这可能是医学专家所认为冲鼻治疗无效要考虑开刀的病人。
但放置于狭窄的下降段B1D上方的本发明本发明可塌陷导管本体61，因强劲水柱直接垂直喷射邻近的结痂，其所需穿透剥离的只是以mm计算的结痂厚度，因此效果显著。同样地，放置于上临中膈空间D1(参阅图14)及上鼻通道F1(参阅图15)的本发明本发明可塌陷导管本体61，也可以强劲水柱垂直喷射邻近的以mm计算的结痂，因此比只能放置下方中临中膈空间D2或下临中膈空间D3的前案高压导管效果显著。
配合参阅图12～16，因上鼻通道F1较狭窄，粘液容易造成阻塞，空气无法流通，粘液因缺少干化作用而保持液态，容易向后流动堆积在上鼻通道F1与鼻咽J顶部的交接处。相反地，中鼻通道G1的粘液虽也会流入鼻咽，但中鼻通道G1因较上鼻通道F1宽，粘液大部份下滑成为薄层，容易受进出空气的干化成为固态的结痂，只有少部份流向鼻咽J。因此倒流入鼻咽J的粘液主要来自上鼻通道F1。因此冲洗鼻咽J的粘液仍以经由上鼻通道F1直接抵达鼻咽J顶部再以强劲水柱冲洗才能得到最佳的效果，但鼻咽J顶部就有蝶状窦的开口，只有本发明才能达此目的并避免误入蝶状窦。
经由以上实施例的叙述，可知本发明的可塌陷鼻腔喷射导管6确实具有以下功效增进的处：借由扁平封闭末端611及可塌陷的导管本体61特性，使较大的导管可以深入狭窄的冲洗目标，可以喷出远为强劲或数量更多的细长水柱达到更佳的冲洗目的，并可避免误入鼻窦的危险，也可以省去以电脑断层摄影测量中鼻通道及上鼻通道的宽度以选取适当尺寸的导管的麻烦，真正达到有效又方便的目的。
本发明的可塌陷鼻腔喷射导管6，可克服习知冲鼻导管难以完全冲洗鼻腔深处的缺点，可真正改善慢性鼻窦炎患者的症状，并减少使用过程中的不适感，便利于病人外出使用。
惟以上所述者，仅为本发明的较佳实施例而已，当不能以此限定本发明实施的范围，即大凡依本发明申请专利范围及发明说明内容所作的简单的等效变化与修饰，皆仍属本发明专利涵盖的范围内。

Claims (5)

  1. 一种可塌陷鼻腔喷射导管，可配合一注射筒灌注冲洗液以冲洗鼻腔及鼻咽；
    该导管包含一导管本体及一衔接器，该导管本体具有一扁平状封闭末端及一相反于该扁平状封闭末端的开放端，且靠近该扁平状封闭末端处形成有多个边孔，该导管本体是以热塑性弹性体或其他柔软具弹性的材质制成，可供病人自行操作置入鼻腔及鼻咽；
    其特征在于：该导管本体的扁平状封闭末端的最大宽度不小于1mm且其管壁最小厚度不大于0.45mm。
  2. 依据权利要求1所述的可塌陷鼻腔喷射导管，其特征在于，该扁平状封闭末端的最大宽度大于导管本体的最小直径。
  3. 依据权利要求1或2所述的可塌陷鼻腔喷射导管，其特征在于，该导管的硬度介于80Shore A以下，管壁厚度不大于0.45mm。
  4. 依据权利要求1或2所述的可塌陷鼻腔喷射导管，其特征在于，该导管的硬度介于80～90Shore A，管壁厚度不大于0.40mm。
  5. 依据权利要求1或2所述的可塌陷鼻腔喷射导管，其特征在于，该导管的硬度在90Shore A以上，管壁厚度不大于0.35mm。
PCT/CN2016/112048 2016-12-26 2016-12-26 可塌陷鼻腔喷射导管 Ceased WO2018119561A1 (zh)

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PCT/CN2016/112048 WO2018119561A1 (zh) 2016-12-26 2016-12-26 可塌陷鼻腔喷射导管
CN201780058655.6A CN110799166B (zh) 2016-12-26 2017-12-25 可塌陷鼻腔喷射导管
JP2019517405A JP6902095B2 (ja) 2016-12-26 2017-12-25 押し潰し可能な鼻腔噴射カテーテル
CA3042315A CA3042315C (en) 2016-12-26 2017-12-25 Collapsible nasal ejecting catheter
EP17888460.7A EP3560476B1 (en) 2016-12-26 2017-12-25 Collapsible nasal-cavity spray catheter
ES17888460T ES2951639T3 (es) 2016-12-26 2017-12-25 Catéter de eyección nasal aplastable
PCT/CN2017/118170 WO2018121459A1 (zh) 2016-12-26 2017-12-25 可塌陷鼻腔喷射导管
AU2017385152A AU2017385152B2 (en) 2016-12-26 2017-12-25 Collapsible nasal ejecting catheter
MX2019005511A MX2019005511A (es) 2016-12-26 2017-12-25 Cateter plegable de expulsion nasal.
KR1020197010936A KR102222656B1 (ko) 2016-12-26 2017-12-25 접힐 수 있는 비강 분사 카테터
BR112019010682A BR112019010682A2 (pt) 2016-12-26 2017-12-25 cateter de borrifação de cavidade nasal dobrável
US16/349,427 US11000450B2 (en) 2016-12-26 2017-12-25 Collapsible nasal ejecting catheter
IL267256A IL267256B (en) 2016-12-26 2019-06-11 Collapsible nasal irrigation catheter

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US20190282443A1 (en) 2019-09-19
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US11000450B2 (en) 2021-05-11
BR112019010682A2 (pt) 2019-09-17
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KR20190058529A (ko) 2019-05-29
AU2017385152B2 (en) 2020-07-09
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MX2019005511A (es) 2019-07-04

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