The present disclosure relates to a nasal cavity insertion device.
Symptoms such as “loud snoring” and “stop breathing during sleep” occur when the upper airway becomes narrow or blocked while sleeping. The present inventors have previously proposed securing an airway during sleep by inserting a soft, tube-shaped nasal cavity insertion device into the nasal cavity, as disclosed in Patent Document 1 below. When the nasal cavity insertion device is inserted through the naris, the tip thereof reaches the uvula, preventing blockage or narrowing of the airway and helping to ensure breathing.
In order to reduce invasiveness to the living body, it is preferable to insert the device alternately into the left and right nasal cavities rather than inserting the device into only one of the left and right nasal cavities. The nasal cavity insertion tube described in Patent Document 1 is gently curved to fit the shape of the left and right nasal cavities. The left and right devices are mirror images of each other, so a device for the right side cannot be inserted into the left nostril, and a device for the left side cannot be inserted into the right nostril. In order to insert the device alternately into the left and right nasal cavities, it is necessary to prepare two different devices, one for the left side and one for the right side.
If the nasal insertion device was designed to be straight and not curved, the device could be used on either the left or right sides. However, devices that are not curved to fit the shape of the nasal cavity tend to create greater resistance when inserted into the nasal cavity, which can cause pain to the user. If the device is made soft so as not to cause pain, the device will be crushed by the uvula, or the like, inhibiting the ability to ensure air passage in the upper airway.
Therefore the present disclosure provides a nasal cavity insertion device that is minimally invasive and can be used in either the left or right nasal cavity.
A nasal cavity insertion device according to a first aspect of the present disclosure includes a cylindrical tube for insertion into a nasal cavity, and a clipper for securing a rear end side of the tube to a bridge of the nose. In the circumferential direction of the tube, the tube includes a first region, a second region opposite the first region, and a pair of left and right connecting regions connecting the first region and the second region. The clipper is connected to a first of the pair of connecting regions. An outer peripheral surface of the tube is provided with a plurality of grooves extending in the circumferential direction of the tube, the plurality of grooves being arranged at intervals in the axial direction of the tube. The plurality of grooves includes first grooves provided in the first region while avoiding at least the second region, and second grooves provided in the second region while avoiding at least the first region.
A nasal cavity insertion device according to a second aspect of the present disclosure includes a cylindrical tube for insertion into a nasal cavity, and a clipper for securing the tube to a bridge of the nose. In the circumferential direction of the tube, the tube includes a first region, a second region opposite the first region, and a pair of left and right connecting regions connecting the first region and the second region. The clipper is connected to a first of the pair of connecting regions. The first and second regions are formed so that wall thicknesses thereof in the radial direction of the tube are greater than the wall thicknesses of the pair of connecting regions.
According to these aspects, by forming grooves or adjusting the wall thickness of the tube, a tube can be configured that is easy to bend and difficult to crush, thereby providing a nasal cavity insertion device that is minimally invasive and can be used in either the left or right nasal cavity.
In the aspect described above, the tube preferably has a straight central axis in an initial, undeformed state.
According to this aspect, the tube can be easily bent in either direction, making the tube suitable for use as a device for both left and right sides.
In the aspect described above, the first and second grooves are preferably formed in positions that do not overlap with each other in the radial direction of the tube and in the direction in which the first region and the second region face each other.
According to this aspect, even if the tube is bent at the first and second grooves, the tube will not be crushed at the same position from both above and below the first and second regions, making it easier to ensure air passage.
In the aspect described above, the first grooves may be provided so as to avoid the second region and the pair of connecting regions, and the second grooves may be provided so as to avoid the first region and the pair of connecting regions.
According to this aspect, since there is a pair of connecting regions in which neither the first groove nor the second groove is provided, a tube having excellent tensile strength can be formed.
In the aspect described above, the length of each of the plurality of grooves in the circumferential direction of the tube may be 1200 or more to 1500 or less in the circumferential direction of the tube.
According to this aspect, the flexibility of the tube can be adjusted by using grooves of sufficient length.
In the aspect described above, the first grooves may be provided across the first region and the pair of connecting regions. The second groove may be provided across the second region and the pair of connecting regions.
According to this aspect, the flexibility of the tube can be significantly changed by the grooves having a length exceeding 180°. Even tubes with hard rubber hardness can be easily bent and adjusted.
In the aspect described above, in the axial direction of the tube, the tube may have a first portion including a rear end and a second portion including a front end opposite the rear end. The second portion may have an outer peripheral surface provided with a plurality of third grooves extending around the full circumference, across the second region and the pair of connecting regions.
According to this aspect, the third grooves can be provided to make the second portion softer than the first portion. The hardness of the tube can be optimally adjusted for each portion.
In the aspect described above, the depth of each of the plurality of grooves is preferably 45% or more and 65% or less of the wall thickness of the tube.
According to this aspect, both the tensile strength and hardness of the tube can be adjusted.
In the aspect described above, the tube preferably has a front end opposite to the rear end, and the tip part including the front end and a portion in the vicinity of the front end has a tapered shape in which the outer diameter decreases toward the front end.
According to this aspect, even if the front end of the tube comes into contact with the nasal cavity or pharynx, the tube is unlikely to damage the nasal cavity or pharynx, so that the invasiveness can be suppressed even if the nasal cavity insertion device is used repeatedly.
In the aspect described above, the clipper is preferably a resin spring made from a resin material.
According to this aspect, the nasal cavity insertion device can be made entirely of resin material. If a metal spring is included, sterilization by heating in a microwave oven or the like is not feasible, but with this configuration, sterilization by heating in a microwave oven is feasible. This allows for more hygienic use of the device.
According to the present disclosure, a nasal cavity insertion device which is minimally invasive and can be used in either the left or right nasal cavity can be provided.
A preferred embodiment of the present disclosure will be described below with reference to the attached drawings. Note that in each diagram, the same reference numerals designate identical or similar configurations.
The nasal cavity insertion device 1 includes a flexible tube 2 and a clipper 3 connected to a rear end 2T of the tube 2. The tube 2 is formed in a cylindrical shape that is slightly longer than the distance from the naris to the uvula of the user. The length of the tube 2 from the rear end 2T to the front end 2L is, for example, about 120 mm to 160 mm, and varies depending on the height and body type of the user.
The clipper 3 secures the rear end 2T of the tube 2 to the columella to prevent the tube 2 from falling into the body of the user. The clipper is, for example, formed from a material having spring elasticity and has a hook shape. Because the nasal cavity insertion device 1 can be sterilized by heating in a microwave oven, the clipper 3 is preferably a resin spring formed from a resin material such as polycarbonate resin. Note that the material of the clipper 3 is not limited to a resin material, but may be a metal material such as stainless steel.
The clipper 3 is connected to connecting region 23, which is a first of the pair of left and right connecting regions 23 and 24. In the example depicted, the nasal insertion device 1 is oriented to be inserted into the right nostril, and the first connecting region 23 to which the clipper 3 is connected is on the left surface. In this case, the first region 21 becomes the upper surface, the second region 22 becomes the lower surface, and a second connecting region 24 becomes the right surface.
Although not depicted in the drawings, in the orientation in which the nasal cavity insertion device 1 is inserted into the left nostril, the first connecting region 23 to which the clipper 3 is connected is on the right surface. In this case, the first region 21 becomes the lower surface, the second region 22 becomes the upper surface, and the second connecting region 24 becomes the left surface.
The plurality of grooves 10 includes a plurality of first grooves 11 and a plurality of second grooves 12. As depicted in
As depicted in
In the example depicted, a plurality of first grooves 11 are provided at intervals of 10 mm in the axial direction Dz of the tube 2. Similarly, a plurality of second grooves 12 are provided at intervals of 10 mm. The first grooves 11 and the second grooves 12 are formed at positions offset from each other by 5 mm in the axial direction Dz of the tube 2.
The length of each of the first grooves 11 in the circumferential direction Dθ of the tube 2 is, for example, 900 or more to 150° or less, and preferably 1200 or more to 150° or less. In the example depicted in
The tapered shape may be, for example, a streamlined shape in which the curvature of the cross section changes continuously, a fillet (rounded chamfer) in which the curvature of the cross section does not change, or a taper in which the cross section is a straight conical surface. Preferably the shape is streamlined or a fillet. In the example depicted, the tip part 51 including the portion 3 mm from the front end 2L is formed in a streamlined shape.
According to the nasal cavity insertion device 1 of the Embodiment 1 configured as described above, the tube 2 can be easily bent at the grooves 10, and therefore the user feels only slight discomfort when inserting the nasal cavity insertion device 1 into the nasal cavity. Since it is not necessary to make the rubber hardness of the tube 2 extremely soft, the tube 2 is unlikely to be crushed by the uvula or the like. Therefore, a nasal cavity insertion device 1 that is minimally invasive and can be used in either the left or right nasal cavity can be provided.
In the facing direction Dv in which the first region 21 and the second region 22 oppose each other, the first grooves 11 and the second grooves 12 are formed at offset positions so as not to overlap with each other, so that the tube 2 is less likely to be crushed by the uvula, or the like. This ensures proper air flow. Since the tip part 51 of the tube 2 is formed in a tapered shape, even if the front end 2L of the tube 2 contacts the nasal cavity or pharynx, injury to the nasal cavity or pharynx is unlikely. Even if the nasal cavity insertion device 1 is used repeatedly, the invasiveness can be reduced.
In the Embodiment 2 to Embodiment 5, descriptions of matters common to Embodiment 1 will be omitted, and only the differences will be described.
In the example indicated, the outer circumference of the tube 2 is a perfect circle, and in the internal space of the tube 2, the distance between the first and second regions 21, 22, in other words, the height h of the internal space, is smaller than the distance between the pair of connecting regions 23, 24, in other words, the width w of the internal space. Although not depicted, similar to Embodiment 1, the first grooves 11 are provided in the first region 21 of the tube 2 so as to avoid the pair of connecting regions 23 and 24. The second grooves 12 are provided in the second region 22 so as to avoid the pair of connecting regions 23 and 24.
According to Embodiment 2 configured as described above, the tube 2 is formed thick in the first and second regions 21, 22, so that the internal space of the tube 2 is less likely to collapse even if the uvula or the like comes into contact the first or second region 21, 22. Since the grooves 10 are provided in the first and second regions 21, 22 which are formed thick, the tube 2 is not excessively rigid and can be bent. Similar to Embodiment 1, a nasal cavity insertion device 1 that is minimally invasive and can be used in either the left or right nasal cavity can be provided.
The tube 2 according to Embodiment 3 has, in the axial direction Dz of the tube 2, a first portion 4 including a rear end 2T (depicted in
The first portion 4 is provided with the plurality of first and second grooves 11, 12. The second portion 5 is provided with the third grooves 13. In the example depicted, the second portion 5 is defined as a portion extending 30 mm from the front end 2L of the tube 2, and a plurality of third grooves 13 are provided in the second portion 5 at intervals of 5 mm.
The first portion 4 has a gentler curve than the second portion 5. Since the first and second grooves 11, 12 of Embodiment 4 are provided in the first portion 4, the length in the circumferential direction Dθ of the tube 2 may be shorter than that of the first and second grooves 11, 12 of Embodiment 1. In the example depicted, the length of each of the first and second grooves 11, 12 is 90°.
According to the nasal cavity insertion device 1 of Embodiment 3 configured as described above, providing of the third grooves 13 enables the second portion 5 to be softer than the first portion 4. Since the hardness of the tube 2 can be optimally adjusted for each portion, a nasal cavity insertion device 1 that is minimally invasive and can be used in either the left or right nasal cavity can be provided.
As depicted in
In the nasal cavity insertion device 1 of Embodiment 4 configured as described above, by providing the grooves 10 that are longer than those in Embodiment 1, the flexibility of the tube 2 can be changed dramatically. Since even the tube 2 having a hard rubber hardness can be easily bent and adjusted, a nasal cavity insertion device 1 that is minimally invasive and can be used in either the left or right nasal cavity can be provided.
According to the nasal insertion device 1 of Embodiment 5 configured as described above, the tube 2 is formed to be thick in the first and second regions 21, 22. Therefore, even if the uvula or the like comes into contact with the first or second region 21, 22, the internal space of the tube 2 is unlikely to be crushed. Since the rubber hardness can be made softer than when a tube 2 with a uniform thickness is used, a nasal cavity insertion device 1 that is minimally invasive and that can be used in either the left or right nasal cavity can be provided.
The embodiments described above are for ease of understanding of the present disclosure and are not intended to be construed as limiting the present disclosure. Elements included in the embodiment, as well as arrangements, materials, conditions, shapes, sizes, and the like thereof, are not limited to those exemplified, but rather can be appropriately changed. In addition, the configurations shown in the various embodiments can be partially replaced or combined with each other.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/JP2022/012572 | 3/18/2022 | WO |