Nasal Flushing Catheter

Abstract

A nasal flushing catheter, made of silicone latex, thermoplastic elastomer or other soft and elastic material, can be operated by the patients. The catheter has a closed end and an open end on the opposite side. There are multiple side-holes near the closed end. This catheter, when adapted to a connector and further connected to a syringe, can eject multiple strong thin spouts within the nasal cavity and nasopharynx for cleansing mucus and crust. The catheter may contain at least one stylet to improve its controllability. By a given injection rate of 10 cc/sec using a syringe, the average vertical height of spouts can be predicted by the total area of side-holes, the catheter is therefore classified as following: 1. a low pressure catheter, having 3.367 mm.sup.2?4.123 mm.sup.2 of total areas of side-holes to eject 30 to 45 cm spouts; 2. a medium pressure catheter, having 2.381 mm.sup.2?3.367 mm.sup.2 of total area of side-holes to eject 45 to 90 cm spouts and 3. a high pressure catheter, having less than 2.381 mm.sup.2 of total area of side-holes to eject longer than 90 cm spouts.

Claims

1. A nasal flushing catheter, is adapted to a syringe for flushing the nasal cavity and nasopharynx, wherein the nasal flushing catheter comprises a catheter body and a connector formed outside of the catheter body; the catheter body is made of silicone, latex, thermoplastic elastomer or other soft and elastic material, rendering insertion by patient into the nasal cavity and nasopharynx; and the catheter body has a closed end, an open end on the opposite side, and a plurality of side-holes disposed near the closed end; wherein the total area of the said plurality of side-holes is not more than 4.123 mm.sup.2.

2.-9. (canceled)

10. The nasal flushing catheter as claimed in claim 1, wherein the total area of side-holes of the catheter body is between 3.367 mm.sup.2?4.123 mm.sup.2 in range.

11. The nasal flushing catheter as claimed in claim 1, wherein the total area of side-holes of the catheter body is between 2.381 mm.sup.2?3.367 mm.sup.2 in range.

12. The nasal flushing catheter as claimed in claim 1, wherein the total area of side-holes of the catheter body is smaller than 2.381 mm.sup.2.

13.-14. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 is a sagittal section view of the human nasal cavity.

[0027] FIG. 2 is a coronal section view of middle portion of nasal cavity along the a-a line in FIG. 1.

[0028] FIG. 3 is a coronal section view of the middle part of the nasal cavity showing the extension of mucus and crust from superior para-septal space, superior nasal meatus and middle nasal meatus to inferior para-septal space in a patient of chronic sinusitis.

[0029] FIG. 4 is a cross-sectional view of a nasal irrigation device disclosed in Taiwan patent no. M418689.

[0030] FIG. 5 is a perspective view of a nasal flushing catheter device disclosed in Taiwan patent No. 101125880.

[0031] FIG. 6 is a perspective view of the nasal flushing catheter according to the first embodiment of the present invention.

[0032] FIG. 7 is a partial top view of the nasal flushing catheter showing denser distribution of the plurality of side-holes closer to the closed end.

[0033] FIG. 8 is a partial cross-sectional view of the nasal flushing catheter according to the second embodiment of the present invention.

[0034] FIG. 9 is a partial cross-sectional view of the nasal flushing catheter according to a third embodiment of the present invention.

[0035] FIG. 10 is a partial cross-sectional view of the nasal flushing catheter according to a fourth embodiment of the present invention.

[0036] FIG. 11 is a partial cross-sectional view of the nasal flushing catheter according to a fifth embodiment of the present invention.

[0037] FIG. 12 is a partial cross-sectional view of the present invention, showing the connection condition of a connector and the catheter body.

[0038] FIG. 13 is a partial cross-sectional view of the present invention, showing the connection condition of a connector and the catheter body as well as the safety design of the stylet.

[0039] FIG. 14 is a coronal section view of the middle part of the nasal cavity, showing the crooked and narrow paths of the superior nasal meatus and the middle nasal meatus.

[0040] FIG. 15 is a sagittal section view of the human nasal cavity, showing the catheter placed in the middle nasal meatus for flushing.

[0041] FIG. 16 is a sagittal section view of the human nasal cavity, showing the catheter placed in the upper nasal meatus for flushing.

[0042] FIG. 17 is a coronal section view of the human nasal cavity, showing the catheter placed in the inferior para-septal space for flushing.

[0043] FIG. 18 is sagittal section view of the human nasal cavity, showing the catheter placed in the nasopharynx for flushing.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] The relevant features and the technical fields of the present invention will be illuminated by the description of the preferred embodiments as well as the accompanying drawings.

[0045] Please refer to FIG. 6 and FIG. 7, showing the nasal flushing catheter 6 of the first preferred embodiment of the present invention. In the first preferred embodiment, the nasal flushing catheter 6 can be adapted to a syringe 7 for rinsing the nasal cavity and nasopharynx of the human body.

[0046] In the first preferred embodiment, the nasal flushing catheter 6 includes a catheter body 61, and a connector 62 formed outside of the catheter body 61. The said catheter body 61 is made of silicone, latex, thermoplastic elastomers or other soft and elastic material which can be operated by patient to put into the nasal cavity and nasopharynx. The catheter body 61 has a closed end 611 and an open end 612 on the opposite side of the closed end 611. A plurality of side-holes 613 is circumferentially distributed in a segment near the closed called flushing section 610. The plurality of the said plurality of side-holes 613 may be evenly distributed or denser distribution closer to the closed end 611 (as shown in FIG. 7).

[0047] Please refer to FIG. 8. FIG. 8 shows the nasal flushing catheter 6 of the second preferred embodiment of the present invention. This second preferred embodiment is substantially similar with the first preferred embodiment. The similarities are omitted here, and the difference is presence of a metallic stylet 8 within the catheter. This stylet has been undergone anticorrosive treatment and has a tapered end.

[0048] Please refer to FIG. 9. FIG. 9 shows the nasal flushing catheter 6 of the third preferred embodiment of the present invention. This third preferred embodiment is substantially similar with the second preferred embodiment. The difference is that the metallic stylet 8, here the stylets are uniform in diameter but different in length. The number of metallic stylet 8 in this embodiment is 3. In the actual implementation, it is not restricted in three stylets and could be other numbers of stylets.

[0049] Please refer to FIG. 10. FIG. 10 shows the nasal flushing catheter 6 of the fourth preferred embodiment of the present invention. The fourth preferred embodiment is substantially similar to the second or third preferred embodiment except some differences. The differences are the outer diameter of the catheter body 61 and the material of stylet. The outer diameter of the catheter body 61 is not more than 1.0 mm, and defined as the micro-catheter. The stylets are made of tungsten alloy undergone anticorrosive treatment with diameter not larger than 0.1 mm.

[0050] Please refer to FIG. 11. FIG. 11 shows the nasal flushing catheter 6 of the fifth preferred embodiment of the present invention, which the fifth preferred embodiment is substantially similar with the fourth preferred embodiment except an additional small end-hole 614 is formed at the closed end side 611 of the catheter body 61. The nasal flushing catheter 6 further includes a stylet 8 made of tungsten alloy undergone anticorrosive treatment with diameter not larger than 0.1 mm and tapered end.

[0051] The following is the detailed description about the manufacture of catheter, the relationship between the side-holes and the height of the vertical spout, the manufacture of side-holes as well as their arrangement, the relationship between the catheter and the side-holes, the design of stylet, the connector, the selection of the syringe, the actual operation, and the improvement of the therapeutic effect for nasal flushing catheter 6 of the present invention.

[0052] The Manufacture of Catheter

[0053] The said catheter body 61 is made of silicone, latex, thermoplastic elastomer or other soft and elastic materials. The said catheter body 61 has a closed end 611, an open end 612 on the opposite side of the closed end 611, and a flushing section 610 near the closed end having a plurality of side-holes 613 disposed circumferentially. The widest inferior nasal meatus H1 and the inferior para-septal space 13 of the nasal cavity, are not wider than 4 mm in normal person, and may be 2.5 mm or even narrower than 1.5 mm in patients with chronic sinusitis. The narrowest superior nasal meatus, is usually not wider than 1.5 mm in normal person, and even narrower than 1 mm in patients with chronic sinusitis. Therefore, the outer diameter of the catheter of the present invention is not larger than 4 mm, and preferably, between 0.5?2.5 mm. A catheter with outer diameter less than 1.0 mm is called a micro-catheter. A micro-catheter may have 0.6 mm or even 0.3 mm inner diameter. Because micro-catheter may be easy to burst during flushing action, an additional small end-hole may reduce the possibility of such risk. The wall thickness of catheter is less than 1 mm, and preferably between 0.1?0.6 mm.

[0054] The Relationship Between the Side-Holes and the Height of the Vertical Spout

[0055] The average initial velocity (V.sub.0) of side-holes 613 spout can determine the average vertical height h. The equations can be deducted as followings: V.sub.0=.sub.gt or t=V.sub.0/g, wherein, g is the gravitational constant 9.8 m/sec.sup.2, t is the time reaching the vertical apex. The maximum vertical apex h, can be determined by the equation h=1/2(gt.sup.2), plugging t=V.sub.0/g, and h=1/2(g)(V.sub.0/g).sup.2=V.sub.0.sup.2/2.sub.g or V.sub.0.sup.2=2gh; furthermore, the average initial velocity (V.sub.0) of side-holes 613 spout can be determined by the injection rate (IR) and the total area of side-holes (TA), the equation is as following: V.sub.0=IR/TA, when applies to the function V.sub.0.sup.2=2gh, and then will get (IR/TA).sup.2=2gh, or TA.sup.2=IR.sup.2/2gh, or TA=?{square root over (IR.sup.2/2gh)}. Even the 10 cc, 20 cc, 50 cc, 60 cc, and 100 cc syringes 7 are all available easily, for considering the operability and avoiding choking phenomenon by large flow of water, the 10 cc syringe 7 may be the best choice. Hence, the 10 cc syringe 7 was chosen as a standard syringe of the present invention. Manual injection of a 10 cc syringe may reach a injection rate (IR) from 5 cc/sec to 15 cc/sec, hence, the medium value of 10 cc/sec is chosen as the standard injection rate. Under this standard injection rate, spout of 30 cm can be expected by side-holes 613 with total area TA=?{square root over (100/(2?9.8 m?0.3 m))}=4.123 mm.sup.2; similarly, spout of 45 cm can be expected by side-holes 613 with total area TA=?{square root over (100/(2?9.8 m?0.45 m))}=3.367 mm.sup.2 and spout of 90 cm can be expected by side-holes 613 with total area TA=?{square root over (100/(2?9.8 m?0.9 m))}=2.381 mm.sup.2. In conclusion, a catheter with a total area of side-holes 613 between 3.367 mm.sup.2?4.123 mm.sup.2 to produce 30?45 cm low pressure spouts is called a low pressure catheter; a catheter with a total area of side-holes 613 between 2.381 mm.sup.2?3.367 mm.sup.2 to produce 45?90 cm medium pressure spouts is called a medium pressure catheter; a catheter with less than 2.381 mm.sup.2 total area side-holes 613 to produce over 90 cm high pressure spouts is called a high pressure catheter. Due to the prior invention can already eject 30 cm spouts, the low pressure spout is defined as 30?45 cm.

[0056] The Manufacture and Arrangement of Side-Holes

[0057] The said side-holes 613 can be produced by traditional method of removing a part of the catheter wall, and can also be produced by puncturing method using a solid metallic needle with a conical tip. The size of side-holes is between 0.1 mm and 1 mm, and preferably between 0.2 mm and 0.5 mm. The number of 0.5 mm diameter side-holes can be made from 4.123 mm.sup.2 total area is 4.123 mm.sup.2?0.5 mm?0.5 mm?0.785=21 the number of 0.3 mm side-holes is 58 and the number of 0.2 mm side-holes is 131. The number of 0.5 mm diameter side-holes can be made from 3.367 mm.sup.2 total area is 3.367 mm.sup.2?0.5 mm?0.5 mm?0.785=17 the number of 0.3 mm side-holes is 47 and the number of 0.2 mm side-holes is 107. The number of 0.5 mm diameter side-holes can be made from 2.381 mm.sup.2 total area is 12, the number of 0.3 mm side-holes is 33 and the number of 0.2 mm side-holes is 75.

[0058] During forceful injection, the closer to the closed end it is, the higher the intraluminal pressure is. Therefore, the side-holes 613 are designed to be more densely disposed near the closed end 611 (as shown in FIG. 8), or a shorter flushing section 610 is designed to avoid the over expansion at the distal end to endure higher pressure for ejecting the strongest spouts. Under a given total area of side-holes 613, the smaller the side-holes 613 are, the more side-holes 613 can be disposed, and the more they are widely distributed, which the wider area can be flushed. Under a given quantity of the side-holes 613, the smaller the side-holes 613 is, the smaller the total area is so that the stronger the injecting spouts are produced. Besides, the micro-catheter can only endure very little pressure, and can be used in a very narrow space without high pressure spout. Its purpose is for evenly transporting flushing liquid in the narrow slot pace, and using blade or laser to produce linear side-holes parallel to the catheter, so that the pressure in the catheter can be lowered during operation without affecting the catcher structure and the total area of side-holes can be increased.

[0059] The Relationship Between the Catheter and the Side-Holes

[0060] The height of spout can be determined by the injection rate (IR) and the total area of side-holes (TA), but only when the catheter can endure high pressure. Because of nasal cavity size, the catheter cannot expand unlimitedly, and the height of spout cannot either. Therefore, the height of high pressure spouts is defined as above 90 cm. Under a given outer diameter of the catheter body 61, the thinner the wall of the catheter is, the larger the inner diameter is and the lower the resistance on forceful injection, but easier to cause elastic fatigue. The said elastic fatigue will cause dilatation of the side-holes, increasing the total area of side-holes 613 and reducing the strength of spouts. However, the thicker wall and the smaller inner diameter of the catheter may cause smaller flow rate and greater resistance, which is not good for forceful injection to eject strong spouts. Therefore, the wall thickness and the inner diameter must be balanced. Although the stronger spouts may be more effective, however, stronger spouts may cause tingling sensation, and is also accompanied with smaller total area resulting in smaller number of side-holes that only smaller area can be cover during the flushing action, in other words, it is less efficient. Therefore if the symptoms are not so bad, the mucus is not so sticky and the solid crust is not so much, then the medium pressure or low pressure spouts may be enough to improve the symptoms. Besides, the area of side-holes for medium pressure or low pressure catheter is larger, the resulting larger number of side-holes can be disposed longer on the catheter to cover a larger area during flushing action, in other word, medium pressure or low pressure catheter is less effective but more efficient. Therefore, the three kinds of catheters have their definite indication, and no one shall be given up.

[0061] The Design of Stylet

[0062] A catheter with larger outer diameter and thicker wall has better controllability. However, a catheter should be smaller than the narrowest part of the insertion route to the target area of nasal cavity, a catheter smaller than 2 mm or even 1.0 mm in outer diameter may be difficult to operation and advancement. In addition to the hardness of the catheter, a gradual transition from hard to soft toward the distal close-end is necessary for excellent controllability. An easy solution to this problem is to put metallic stylet within the lumen of catheter. The metallic stylet should be undergone anticorrosive treatment. The metallic stylet 8 may be single in number having a tapered end or multiple in number with uniform diameter and different in length (as shown in FIG. 8 and FIG. 9). Furthermore, in some patients, the narrowest place of the route reaching the upper nasal meatus, the middle nasal meatus or superior para-septal space might be less than 1.0 mm, and even might be only 0.5 mm which can only be overcome by even smaller catheters. The inner diameter of such micro-catheter might be small as 0.6 mm or even 0.3 mm. Therefore, the stylet 8 must be further smaller, and the tungsten alloy is the choice for such stylets 8 which meets the requirement of smallest diameter and largest hardness, because the tungsten is the hardest metal (as shown in FIG. 10 and FIG. 11).

[0063] The Connector

[0064] Please see FIG. 5, the Taiwan patent No. 101125880 disclosed a nasal flushing device, the outlet of the connector is inserted into the inlet of the catheter body. Not only the connector restricts the water flow, but also the connecting part of the catheter body is expanded to have thinner wall and hence cannot endure the pressure of injection. Therefore, the outlet of the connector 62 of this present invention is wrapped in the inlet of catheter by bigger inner diameter to solve the above mentioned problems. The security of connecting place can be accomplished by friction, powerful adhesive agent, thermoplastic change or other means. Furthermore, due to the very small inner diameter of the micro-catheter and the inside disposition of the stylets 8, the wrapping connector 62 makes more space to accommodate the stylets (as shown in FIG. 12). The stylets 8 can have a safe design at the connecting place to avoid forward moving during flushing action (as shown in FIG. 13).

[0065] The Selection of the Syringe

[0066] Even the 20 cc, 30 cc, and 60 cc syringes 7 are all available, they are not easy to operate due to their large size; therefore, a 10 cc syringe is the choice. However, the syringes 7 must be adjusted according the diameter of the catheter body 61. A catheter body 61 over 2 mm in outer diameter may use 10 cc syringe 7; a catheter body 61 with 1.5?2 mm outer diameter may use 5?10 cc syringe 7; a catheter body 61 having 1?1.5 mm outer diameter may use 1?5 cc syringe 7; A micro-catheter with less than 1 mm in outer diameter may use 1?2 cc syringe 7 in order to avoid bursting of the catheter.

[0067] The Actual Operation

[0068] The handmade catheter of the prior nasal flushing catheter had been tried by our family members and close friends before filing the present invention for more than 2 years, meanwhile, the catheter of the present invention has also been tried for more than one year, hence, we have a lot of experiences and are familiar with all details of flushing treatment. Although the computed tomography can objectively assess the efficacy, the subjective assessment by the patient is more important. There are two issues for assessing the therapeutic effect: one is the amount of mucus wash out during or after flushing, the more the amount of mucus the better it is; the other is subjective feeling of symptom improvement, such as the severity of nasal obstruction, foreign body sensation in the throat and cough, of course these symptoms related to quality of sleep and daytime activity. Both of them have to be considered. If a patient using the catheter of the prior invention (FIG. 5) and inserts deeply enough within the nasal cavity (at least inserts by over 8?10 cm), but still not satisfied with the flushing effect, the possible explanation may be that: the catheter was not inserted into the target areas of middle nasal meatus and upper nasal meatus, or because the spout is not strong enough to penetrate the crust. At this moment, the patient is better to visit the doctor to receive a computed tomography of the nasal cavity. For considering flushing treatment every day, a single computed tomography is worthy for patient.

[0069] If the result of computed tomography is like FIG. 14, the nasal cavity is divided into three slightly curved slit-like passages by three plate-like structures. The three passages are the upper nasal meatus F1, the middle nasal meatus G1 and the lower nasal meatus H1. The three plate-like structures are the superior turbinate F, the middle turbinate G, and the inferior turbinate H. Although the nasal passage is not completely obstructed and there is no much mucus, the upper turbinate F, the middle turbinate G, and the lower turbinate H appear bigger than normal person, and the upper nasal meatus F1, the middle nasal meatus G1 as well as the lower nasal meatus H1 appear narrower than normal person. The enlarged turbinate should be caused by coating of thick crust resulting in narrowing of nasal meatus. If the outer diameter of the catheter used is bigger than the middle meatus G1, then the unsatisfactory flushing effect may be due to unable to enter the target area. It is necessary to review all the coronal cross-sectional views from front to back, measuring the narrowest point of the insertion route, and select a catheter body 61 smaller than this narrowest point. The design of stylet 8 renders the catheter body 61 a good controllability. As shown in FIG. 14 and FIG. 15, a catheter inserted from the nasal vestibule E to the inferior para-septal space 13, and deviates laterally can reach the middle nasal meatus G1 (FIG. 15) when inserted more than 5-6 cm deep; a catheter inserted from nasal vestibule, through inferior para-septal space 13, middle para-septal space 12 then deviating laterally can reach the superior nasal meatus F1 (FIG. 16) when inserted more than 7-8 cm deep. Because the catheter body 61 has already reached the target area, although the flow rate of the catheter is small and the spouts are weak, it is enough for direct penetration of the crust to achieve a good flushing effect.

[0070] If the result of computed tomography is like FIG. 17, due to the mucus or the solid crust are accumulated from narrow the superior nasal meatus F1 and the middle nasal meatus G1 downward to the inferior para-septal space 13, the respiratory air cannot pass through the upper part of nasal cavity but still can easily pass through the non-obstructed inferior part of nasal cavity. Due to the drying effect of respiratory air, the lower edge of the mucus accumulation becomes a solid hard crust. In such situation, the 30 cm spout of the prior nasal flushing catheter is inadequate for penetrating such hard crust. The patient can choose medium a pressure catheter or high pressure catheter for insertion under through the inferior para-septal space 13 below the solid crust, the medium pressure spouts or high pressure spouts from the catheters may have better penetrating and cleaning effect, and quickly relieve the symptoms of nasal obstruction.

[0071] Please refer to FIG. 18, the nasopharynx J is a wide passage for respiratory air, the mucus migrates into the nasopharynx J will quickly transform to solid crust by the drying effect of respiratory air. The single direction spout of the conventional flushing device can only flush the rear wall of the nasopharynx J, but cannot flush the roof and both sides of the nasopharynx J. Moreover, if exerting more pressure, the huge spouts could be accompanied by a large flow to cause choking phenomenon. Even the 30 cm spout of the prior nasal flushing catheter is too weak to penetrating to the thick solid crust. In such situation, the patient can insert a medium pressure or high pressure catheter with a curve tip horizontally through the inferior nasal meatus H1, middle nasal meatus G1 or para-septal space I into the nasopharynx J, then by rotating the catheter to direct the catheter tip up to the roof of nasopharynx. By forceful injection of a syringe 7 to produce stronger spouts, the solid crust in the nasopharynx J can be penetrated resulting in good cleansing effect.

[0072] From the above description, a patient can choose a catheter as needed. Due to the presence of the stylet 8, the nasal flushing catheter has better controllability and is easy to enter the superior nasal meatus F1, middle nasal meatus G1, lower nasal meatus H1 and the nasopharynx J to clean mucus and solid crust.

[0073] From the above detailed description of the embodiments, it can be known that the nasal flushing catheter of the present invention has the following effects:

[0074] 1. It is possible to flush the narrow nasal passages directly by a micro-catheter which is easy to be operated.

[0075] 2. Due to the improvement of the connector 62, a catheter can eject stronger spouts to improving cleansing effect without increasing the diameter.

[0076] 3. The strength of the spouts can be predicted by the total area of side-holes 613, so that the stronger the spout, the better the effect.

[0077] 4. Through the controllability of the catheter, the position of the catheter body 61 can be adjusted in the nasopharynx J, thus strong spouts can be ejected to clean the mucus and solid crust within the nasopharynx J.

[0078] The nasal flushing catheter of the present invention can overcome the disadvantages of the prior nasal flushing device by better controllability to achieved deep insertion to small deep recess of the nasal cavity and by stronger spouts to penetrate solid crust. This is very important in improving the symptoms of patients with chronic sinusitis. Meanwhile, it is also convenient for the patient in travelling.

[0079] The above descriptions are only explanations according to the five preferred embodiments, and should not limit the scope the present invention. It is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention as hereinafter claimed.