JP2014050534A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device capable of more effectively restraining airway blockage from being caused by biotissue, constituting an airway, such as the soft palate and a tongue.SOLUTION: A medical device includes a first shank 11 and a second shank 21 which are inserted into biotissue constituting an airway, and a first regulation part 12 and a second regulation part 22 which are arranged in the airway in the state of being connected to ends of the first shank 11 and second shank 21 and which regulate airway blockage by coming into contact with a surface facing a region where they are arranged in the airway.

Description

  The present invention relates to a medical device used for the treatment of respiratory disorders such as snoring, upper airway resistance syndrome and obstructive sleep apnea syndrome.

  Breathing disorders such as snoring, upper airway resistance syndrome and obstructive sleep apnea syndrome occur when the tongue base and soft palate block the upper airway during sleep. The continuous positive airway pressure method (CPAP) is known as a method for suppressing the obstruction of the upper airway due to the obstructive sleep apnea syndrome or the like. In the continuous positive airway pressure method, a mask connected to a ventilator is attached around the nose, and the upper airway is maintained at a positive pressure, thereby suppressing obstruction of the upper airway. However, the continuous positive airway pressure method has a strong feeling of pressure on the mask and needs to be used every night.

  As another treatment method, there is a method in which a soft palate or a part of the tongue is surgically removed. However, this method is highly invasive and has a great burden on the patient. Therefore, there is a need for a method that can achieve a therapeutic effect with minimal invasiveness, and by causing a fibrosis reaction in the tissue of the soft palate by high-frequency cauterization, the soft palate is cured, or an instrument is embedded in the soft palate or tongue, thereby Methods for preventing occlusion are being investigated.

  For example, Patent Document 1 describes a method of suppressing occlusion of the upper airway by providing a soft palate and a device that is completely embedded in the tongue, thereby suppressing the soft palate and tongue from falling into the pharynx. Yes.

  Patent Document 2 describes a method in which a soft palate is embedded with a substance that induces soft tissue fibrosis to harden the tissue, and the soft palate is prevented from dropping into the pharynx and the upper airway is blocked. .

  Further, Patent Document 3 discloses that the upper airway is formed even if the tongue base falls into the pharynx by partially limiting the thickness of the tongue with a device that penetrates the tongue like a piercing and forming a recess in the tongue base. A method for suppressing complete occlusion is described.

US Pat. No. 7,337,781 US Pat. No. 6,431,174 U.S. Pat. No. 8,074,655

  However, in the methods described in Patent Documents 1 to 3 described above, excellent effects are not obtained clinically.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a medical device that can more effectively suppress obstruction of an airway due to a tissue constituting the airway such as a soft palate and a tongue. .

  A medical device that achieves the above-described object is arranged in an airway connected to an end portion of the shaft portion inserted into a living tissue constituting the airway, and in contact with a facing surface of a portion arranged in the airway The medical device which has a control part which controls obstruction | occlusion of an airway by this.

  In the medical device configured as described above, the restricting portion restricts airway obstruction by contacting an opposing surface of a portion disposed in the airway, and thus airway obstruction can be more reliably suppressed.

  If the restricting portion can be elastically deformed in a direction orthogonal to the inner wall surface of the airway, the burden on the living tissue that is a contact target can be reduced, and the necessary biological motion to block the airway acts. In this case, the restricting portion is deformed and the movement is not hindered.

  If the shaft portion has a hole portion penetrating in the axial direction, the deformation of the restriction portion can be operated through the hole portion from the opposite side of the shaft portion on the side where the restriction portion is provided. For this reason, the restricting portion can be easily deformed into a shape that can pass through the through-hole formed in the living tissue, and can be easily attached to and detached from the living tissue.

  If the restricting portion has a gap portion that penetrates in the direction along the inner wall surface of the airway, air can flow through the gap portion, and the restriction portion itself can be prevented from obstructing breathing. .

  If a plurality of configurations including the shaft portion and the restriction portion are provided and connected to each other, the blockage of the airway due to the living tissue can be more effectively suppressed by causing the plurality of configurations to function in conjunction with each other.

  If the restricting part is removable from the shaft part, the restricting part can be attached only during sleep and can be removed except during sleep, thereby reducing the burden on the patient and improving the quality of life. Moreover, since it is not necessary to remove a shaft part from a biological tissue when removing a control part, it becomes easy to attach a control part again.

  If the restricting portion has a holding portion capable of holding the liquid, the restricting portion can hold the lubricant and the like, and the load on the living tissue with which the restricting portion comes into contact can be reduced.

It is a schematic sectional drawing which shows the time of attaching the medical device which concerns on 1st Embodiment to a soft palate and a tongue. It is a schematic sectional drawing in alignment with the AA of FIG. It is a top view which shows the 1st instrument of the medical device which concerns on 1st Embodiment. It is an arrow line view which shows the 1st instrument seen from the arrow line B of FIG. It is sectional drawing which follows the CC line of FIG. It is a top view which shows the 2nd instrument of the medical device which concerns on 1st Embodiment. It is an arrow line view which shows the 2nd instrument seen from the arrow line D of FIG. It is a top view which shows the attachment jig | tool for attaching the 1st instrument of the medical device which concerns on 1st Embodiment to a soft palate. It is a perspective view which shows the front-end | tip part of a holding jig. It is sectional drawing which shows the time of hold | maintaining the 1st instrument of the medical device which concerns on 1st Embodiment to an attachment jig, (A) is a 1st control part, when it deform | transforms linearly, (B) 1 shows the case where the regulating portion is bent. It is a schematic sectional drawing which shows the time of attaching the 1st instrument of the medical device which concerns on 1st Embodiment to a soft palate with an attachment jig. It is a schematic sectional drawing which shows the time of attaching the 1st instrument of the medical device which concerns on 1st Embodiment to a soft palate with an attachment jig. It is a schematic sectional drawing which shows the time of attaching the 2nd instrument of the medical device which concerns on 1st Embodiment to the tongue. It is a schematic sectional drawing which shows when the soft palate and tongue which attached the medical device which concerns on 1st Embodiment fell to the pharynx side. It is a top view which shows the 1st instrument of the medical device which concerns on 2nd Embodiment. It is a perspective view which shows the attachment jig | tool for attaching the 1st instrument of the medical device which concerns on 2nd Embodiment to a soft palate. It is sectional drawing which shows the time of hold | maintaining the 1st instrument of the medical device which concerns on 2nd Embodiment to the attachment jig, (A) is a case where (B) 1 shows the case where the regulating portion is bent. It is a schematic sectional drawing which shows the time of attaching the 1st instrument of the medical device which concerns on 2nd Embodiment to a soft palate with an attachment jig. It is a schematic sectional drawing which shows the time of attaching the 1st instrument of the medical device which concerns on 2nd Embodiment to a soft palate with an attachment jig. It is a top view which shows the 1st instrument of the medical device which concerns on 3rd Embodiment. It is a top view which shows when the 1st instrument of the medical device which concerns on 3rd Embodiment is hold | maintained at the attachment jig, (A) is a case where (B) 1 shows a state where the restricting portion is returned to the original spiral shape. It is a schematic sectional drawing which shows the time of attaching the 1st instrument of the medical device which concerns on 3rd Embodiment to a soft palate with an attachment jig. It is a schematic sectional drawing which shows the time of attaching the 1st instrument of the medical device which concerns on 3rd Embodiment to a soft palate with an attachment jig. It is a top view which shows the modification of a 2nd instrument. It is a top view which shows the other modification of a 2nd instrument. It is a schematic sectional drawing which shows the modification of a 1st instrument. It is an arrow line view which shows the 1st instrument seen from the arrow line E of FIG. It is a top view which shows the other modification of a 1st instrument. It is a top view which shows the further another modification of a 1st instrument. It is sectional drawing which shows the further another modification of a 1st instrument.

Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.
<First Embodiment>

  The medical device according to the first embodiment of the present invention is used for the treatment of respiratory disorders such as snoring, upper airway resistance syndrome and obstructive sleep apnea syndrome, and is attached to the soft palate SP or the tongue T. During sleep, the soft palate SP and the tissue of the tongue T fall into the pharynx P located in the back of the throat, thereby preventing the upper airway from being blocked. As shown in FIGS. 1 and 2, the medical device includes three first instruments 10 attached to the soft palate SP and one second instrument 20 attached to the tongue T.

  As shown in FIGS. 1 to 5, each of the first instruments 10 includes a first shaft portion 11 inserted through the soft palate SP from the oral cavity BC side to the pharynx P side, and one end portion of the first shaft portion 11. A first restricting portion 12 that is connected to the pharynx P and is connected to the other end of the first shaft portion 11 and is disposed in the oral cavity BC. .

  The 1st axial part 11 is formed in the cylinder shape, and the hole part 14 is formed in the inside. The length of the first shaft portion 11 is preferably substantially the same as the thickness of the soft palate SP to be attached. However, since the thickness of the soft palate SP changes, it is preferable to be appropriately selected according to the situation. The length of the 1st axial part 11 can be 5 mm-50 mm as an example.

  The 1st control part 12 has the six 1st bending members 15 which become circular arc shape in the natural state where an external force does not act, and the six bending members 11 are arrange | positioned along with the circumferential direction. The first restricting portion 12 is formed in a substantially disc shape as a whole by the six first bending members 15, and the outer diameter D <b> 2 of the disc is larger than the outer diameter D <b> 1 of the first shaft portion 11.

  The six first bending members 15 have one end connected to the end of the first shaft portion 11 and the other end formed with a collective portion 16 connected to each other. The collective portion 16 has a recess 17 formed so as to face the hole 14 of the first shaft portion 11. Note that the number of the first bending members 15 is not limited to six. When the number of the first bending members 15 is small, the runny nose is less likely to be clogged. Further, the concave portion 17 may not be formed in the collecting portion 16.

  The six first bending members 15 are elastically bent and deformable. Therefore, it is possible to change the thickness W1 (refer to FIG. 3) in the direction orthogonal to the inner wall surface of the pharynx P, which has a substantially disk shape constituted by the six first bending members 15. A first gap 18 that is a gap is formed between the first bending members 15. The first gap 18 is formed in the first restricting portion 12 so as to penetrate in the direction along the inner wall surface of the pharynx P. Therefore, air can be circulated in the first gap 18.

  Although the outer diameter D2 in the natural state of the substantially disk shape comprised by the six 1st curved members 15 is not specifically limited, For example, it can be 1 mm-20 mm. Although the outer diameter D1 of the 1st axial part 11 is not specifically limited, For example, it can be 0.5 mm-5 mm. Although the thickness W1 in the natural state of a substantially disk shape is not specifically limited, For example, it can be 1 mm-20 mm.

  The first fastening portion 13 is formed in a substantially spherical shape having an outer diameter D3 larger than the outer diameter D1 of the first shaft portion 11, and a hole portion 14 communicating with the first shaft portion 11 is formed therein. By holding the soft palate SP between the first fastening portion 13 and the first restricting portion 12 having an outer diameter larger than that of the first shaft portion 11, the first instrument 10 is prevented from dropping from the soft palate SP. In addition, the shape of the 1st fastening part 13 will not be limited to spherical shape, if the drop of the 1st instrument 10 can be suppressed, For example, it can be set as columnar shape etc.

  The material of the first instrument 10 may be a material such as polypropylene, polyethylene, polystyrene, ethylene vinyl acetate copolymer, polyvinyl chloride, polyurethane, polyisoprene, natural rubber, preferably silicone, stainless steel, NiTi, fluorine. A material having high biocompatibility such as resin and zirconia is applied. It is also possible to coat the surface of the material with a biocompatible substance. In addition, the 1st instrument 10 may be formed with the same member as a whole, or the material which changes with parts may be applied.

  As shown in FIGS. 1, 2, 6, and 7, the second instrument 20 is detachably provided at the both ends of the second shaft portion 21 and the second shaft portion 21 that penetrates between two points on the surface of the tongue T. Two second restricting portions 22 arranged in the oral cavity BC or the pharynx P.

  The second shaft portion 21 is a solid wire formed by being bent in a natural state so that both end portions are easily located at two locations on the surface of the tongue T. In addition, the 2nd axial part 21 may be hollow, and the structure currently formed in linear form in a natural state, and curving by attaching to the tongue T may be sufficient. A second disc-shaped second retaining portion 23 </ b> A is fixed to one end of the second shaft portion 21, and a screw hole 24 formed in the other end is formed in the other end of the second shaft portion 21. A second fastening portion 23 </ b> B including a screw portion 31 that can be screwed into the screw hole 24 can be connected to an end portion of the second shaft portion 21 having the screw hole 24. In addition, a connecting screw hole 26 to which the second restricting portion 22 can be attached is formed in each of the second fastening portions 23A and 23B.

  The second fastening portions 23A and 23B have an outer diameter D5 that is larger than the outer diameter D4 of the second shaft portion 21. When the tongue T is sandwiched between the second fastening portions 23A and 23B having an outer diameter larger than that of the second shaft portion 21, the second instrument 20 is prevented from falling off the tongue T. Note that the shape of the second fastening portions 23A and 23B is not limited to a cylindrical shape as long as the second instrument 20 can be prevented from falling off, and may be, for example, a spherical shape. The length of the second shaft portion 21 is preferably substantially the same as the length of the hole formed in the tongue T. However, since the shape of the tongue T changes, it is preferably selected as appropriate according to the situation. Although the length of the 2nd axial part 21 is not specifically limited, For example, it can be 10 mm-100 mm.

  As for the 2nd control part 22, the six 2nd bending members 25 used as the circular arc shape in a natural state are arrange | positioned along with the circumferential direction. The second restricting portion 22 is formed in a substantially disc shape as a whole by the six second bending members 25, and the outer diameter D 6 of the substantially disc is larger than the outer diameter D 4 of the second shaft portion 21.

  The six second bending members 25 have one end fixed with a connecting portion 27 connected to the second fastening portions 23A and 23B, and the other end formed with a collective portion 30 connected to each other. Note that the number of the second bending members 25 is not limited to six. The connecting portion 27 is formed with a connecting screw portion 28 that can be screwed into a connecting screw hole 26 formed in the second fastening portions 23A and 23B.

  The six second bending members 25 are elastically bent and deformable. Therefore, it is possible to change the thickness W <b> 2 in the direction perpendicular to the inner wall surface of the pharynx P, which is a substantially disk shape constituted by the six second bending members 25. A second gap 29 that is a gap is formed between each second bending member 25. The second gap portion 29 is formed in the second restricting portion 22 so as to penetrate in the direction along the inner wall surface of the pharynx P, and therefore air can be circulated in the second gap portion 29.

  Although the outer diameter D6 in the natural state of the substantially disk shape comprised by the six 2nd bending members 25 is not specifically limited, For example, it can be set as 1 mm-30 mm. Although the outer diameter D4 of the 2nd axial part 21 is not specifically limited, For example, it can be 0.5 mm-5 mm. Although the thickness W2 in the substantially disc-shaped natural state is not particularly limited, it can be set to, for example, 1 mm to 30 mm.

  The material of the second device 20 can be a material such as polypropylene, polyethylene, polystyrene, ethylene vinyl acetate copolymer, polyvinyl chloride, polyurethane, polyisoprene, natural rubber, and preferably silicone, stainless steel, NiTi, fluorine A material having high biocompatibility such as resin and zirconia is applied. It is also possible to coat the surface of the material with a biocompatible substance. In addition, the 2nd instrument 20 may be formed with the same member as a whole, or a different material may be applied by a site | part. For example, the second shaft portion 21 in which the screw hole 24 is formed, the second fastening portions 23A and 23B in which the connection screw hole is formed, and the connection portion 27 in which the connection screw portion 28 is formed are connected by screwing. It can also be formed of a material having higher rigidity than other parts so as to be kept strong.

  Next, a method for attaching the first instrument 10 to the soft palate SP will be described. When attaching the first instrument 10 to the soft palate SP, an attachment jig 40 shown in FIGS. The mounting jig 40 includes a linear wire member 41 for deforming the first bending member 15 into a substantially linear shape, and a holding jig 42 for holding the first instrument 10.

  The holding jig 42 is formed at a cylindrical beam portion 44 through which the insertion hole 43 passes, an extension portion 45 extending from the beam portion 44 in the axial direction of the beam portion 44, and an end portion of the extension portion 45. And a ring-shaped gripping portion 46 with a part in the circumferential direction cut away. As shown in FIG. 10A, the wire member 41 can be inserted into the insertion hole 43. The first fastening portion 13 can be accommodated between the beam portion 44 and the gripping portion 46, and the gripping portion 46 accommodates the first shaft portion 11 from the notched notch portion 47 to receive the first shaft portion. 11 can be gripped so as to surround it.

  When attaching the first instrument 10 to the soft palate SP, first, a separate needle member (not shown) is inserted into the portion into which the first shaft portion 11 of the soft palate SP is inserted, and a through-hole penetrating from the oral cavity BC to the pharynx P Form. Thereafter, as shown in FIG. 10A, the first fastening portion 13 is disposed between the beam portion 44 and the grip portion 46 of the holding jig 42, and the first shaft portion extends from the notch portion 47 to the grip portion 46. 11 is accommodated. Then, the wire member 41 is inserted into the insertion hole 43 of the beam portion 44 and pushed forward, and the wire member 41 is inserted into the first fastening portion 13 and the hole portion 14 of the first shaft portion 11. When the tip of the wire member 41 is fitted into the concave portion 17 of the collecting portion 16 and then the wire member 41 is further pushed forward, the first bending member 15 that is bent in the natural state is elastically deformed in a substantially linear shape.

  Next, as shown in FIG. 11, while maintaining the state in which the first bending member 15 is elastically deformed substantially linearly, the attachment jig 40 is inserted from the mouth, and the first instrument 10 is inserted into the first restricting portion 12. It inserts into the through-hole formed in soft palate SP from the side. After the first restricting portion 12 passes through the soft palate SP and reaches the pharynx P side, and the first fastening portion 13 comes into contact with the soft palate SP, the wire member 41 is retracted to the proximal end side. As a result, as shown in FIG. 10B, the first restricting portion 12 that has been deformed into a substantially linear shape returns to the original shape. Thereafter, as shown in FIG. 12, when the holding jig 42 is moved laterally so as to disengage the first shaft portion 11 from the notch 47 of the holding jig 42, the first tool is moved from the holding jig 42. 10 is detached, and the installation of the first instrument 10 is completed with the soft palate SP sandwiched between the first fastening part 13 and the first restricting part 12. By repeating this operation, a predetermined number (three in this embodiment) of the first instruments 10 can be attached to different positions of the soft palate SP.

  Further, when it is desired to remove the first instrument 10 from the soft palate SP, the holding jig 42 is inserted into the oral cavity BC through the mouth, and the first fastening portion 13 is interposed between the beam portion 44 and the gripping portion 46 of the holding jig 42. And the first shaft portion 11 is accommodated from the notch portion 47 to the grip portion 46. Then, the wire member 41 is inserted into the insertion hole 43 of the beam portion 44 and pushed forward, the tip of the wire member 41 is fitted into the concave portion 17 of the assembly portion 16, and then the wire member 41 is pushed further forward to FIG. As shown, the first bending member 15 is elastically deformed in a substantially linear shape. Thereafter, when the mounting jig 40 and the wire member 41 are pulled out from the mouth while maintaining the state in which the first bending member 15 is elastically deformed in a substantially linear shape, the first restricting portion 12 of the first instrument 10 becomes the soft palate SP. It is pulled out to the oral cavity BC side through the formed through hole. Thus, by using the attachment jig 40, the first instrument 10 can be easily attached to or detached from the soft palate SP. Therefore, if the through hole penetrating from the oral cavity BC to the pharynx P is formed in the soft palate SP, even the patient himself can easily attach and remove the first instrument 10. In addition, for the purpose of guiding the mounting jig 40 to the first fastening part 13 or for the purpose of facilitating the removal, a material that incorporates a magnet in the mounting jig 40 and attracts the first fastening part 13 to the magnet. It is also possible to comprise.

Next, a method for attaching the second instrument 20 to the tongue T will be described. When attaching the second instrument 20 to the tongue T, first, a separate needle member (not shown) is pierced into a portion into which the second shaft portion 21 of the tongue T is inserted, and penetrates between two points of the tongue T. A U-shaped through hole is formed. In addition, although it is preferable that the site | part which inserts the 2nd axial part 21 of the tongue T is the front end side of the tongue T rather than the line in which an enclosed papillary is lined so that a vomiting reflection may not arise, it is not limited to this. Thereafter, the end portion of the second shaft portion 21 from which the second fastening portion 23B is removed is passed through the through hole of the tongue T in a state where the second fastening portion 23B is detached from the second shaft portion 21. At this time, the two second restricting portions 22 may not be connected to the second fastening portions 23A and 23B. Thereafter, the screw part 31 of the second fastening part 23B is screwed into the screw hole 24 of the second shaft part 21 to be connected, and as shown in FIGS. 2 and 13, between the two second fastening parts 23A and 23B. In the state where the tissue of the tongue T is sandwiched between the second shaft portion 21 and the second retaining portions 23A and 23B, the installation is completed. Then, by screwing the connecting screw portion 28 formed in the connecting portion 27 of the second restricting portion 22 into the connecting screw hole 26 formed in the second fastening portions 23A and 23B (see FIG. 6). The second restricting portion 22 can be connected to the second fastening portions 23A and 23B.
Next, the operation of the medical device according to the first embodiment will be described.

  When the first instrument 10 of the medical device is attached to the soft palate SP, when the soft palate SP falls to the pharynx P side during sleep, the first restricting portion 12 is arranged in the pharynx P as shown in FIG. Touch the opposite surface of the part. Since the first restricting portion 12 has a thickness W1 (see FIG. 3) in a direction orthogonal to the inner wall surface of the pharynx P, upper airway obstruction in the pharynx P is prevented, and snoring, upper airway resistance syndrome and Occurrence of obstructive sleep apnea syndrome is suppressed. Moreover, since the 1st space | interval part 18 penetrated in the direction in alignment with the inner wall face of the pharynx P is formed in the 1st control part 12, air can distribute | circulate through this 1st space | gap part 18, It is possible to prevent the restricting portion 12 itself from obstructing breathing. And by providing the 1st control part 12, the flow path of air can be ensured more reliably like the dashed-dotted arrow shown in FIG. In addition, it is preferable that the position and the number of the first restricting portions 12 are appropriately selected in consideration of the position of the flow path to be secured, the shape of the living tissue, the burden on the patient, and the like.

  And since the 1st control part 12 can be elastically deformed, if it contacts the opposing surface of the site | part by which an upper airway is arrange | positioned, the thickness W1 (refer FIG. 3) of the 1st control part 12 will change. For this reason, the burden to the living tissue which is a contact object can be reduced. In addition, the first restricting portion 12 not only has a rigidity that can suppress the fall of the soft palate SP during sleep, but also does not inhibit the movement when a necessary biological movement to block the pharynx P acts. Thus, it is preferable to have such a rigidity that the thickness W1 is crushed so as to be as small as possible. That is, it is only necessary to prevent complete blockage of the airway.

  Since the first instrument 10 can be easily attached to or detached from the soft palate SP by using the attachment jig 40, a through-hole that first penetrates the soft palate SP from the oral cavity BC to the pharynx P is used. After that, even the patient himself can easily attach and detach. For this reason, the 1st instrument 10 can be attached only at the time of sleep by the patient himself and can be removed except at the time of sleep, and the burden on the patient can be reduced and the quality of life can be improved.

  Further, when the second instrument 20 of the medical device is attached to the tongue T, when the tongue T falls to the pharynx P side during sleep, the second restricting portion 22 is arranged in the pharynx P as shown in FIG. It contacts the opposite surface of the part to be done. Since the 2nd control part 22 has thickness W2 (refer FIG. 6) in the direction orthogonal to the inner wall face of the pharynx P, obstruction | occlusion of the upper airway in the pharynx P is prevented, snoring, upper airway resistance syndrome, and Occurrence of obstructive sleep apnea syndrome is suppressed. Moreover, since the 2nd space | interval part 29 penetrated in the direction in alignment with the inner wall surface of the pharynx P is formed in the 2nd control part 22, air can distribute | circulate through this 2nd space | gap part 29, 2nd The restricting part 22 itself can be prevented from obstructing breathing. And by providing two or more 2nd control parts 22, the flow path of air can be ensured more reliably like the arrow shown in FIG. In addition, it is preferable that the position and the number of the second restricting portions 22 are appropriately selected in consideration of the position of the flow path to be secured, the shape of the living tissue, the burden on the patient, and the like.

  And since the 2nd control part 22 can be elastically deformed, if it contacts the opposing surface of the site | part arrange | positioned in the pharynx P, thickness W2 (refer FIG. 6) will change. For this reason, the burden to the living tissue which is a contact object can be reduced. Further, the second restricting portion 22 not only has a rigidity that can suppress the drop of the tongue T during sleep, but also does not hinder the movement when a necessary biological motion to block the pharynx P acts. Thus, it is preferable to have such a rigidity that the thickness W2 is crushed so as to be as small as possible.

  And since the 2nd control part 22 can attach or remove the 2nd control part 22 with respect to the 2nd axial part 21 attached to the tongue T, the 2nd axial part 21 is attached to the tongue T. After that, even the patient himself can easily attach or remove the second restricting portion 22. For this reason, the 2nd control part 22 can be attached only at the time of sleep by the patient himself and can be removed except at the time of sleep, and the burden on the patient can be reduced and the quality of life can be improved. Moreover, since it is not necessary to remove the 2nd axial part 21 from a biological tissue when removing the 2nd control part 22, it becomes easy to attach the 2nd control part 22 again.

  As described above, according to the medical device according to the present embodiment, the shaft portion (the first shaft portion 11 and the second shaft portion 21) to be inserted into the living tissue constituting the airway and the end portion of the shaft portion are connected. And a restricting portion (first restricting portion 12 and second restricting portion 22) that restricts airway obstruction by being in contact with the opposing surface of the portion that is disposed in the airway, so that the soft palate SP It is possible to more effectively suppress the obstruction of the airway due to the tissue constituting the airway such as the tongue T or the tongue T.

  Further, since the restricting portions (the first restricting portion 12 and the second restricting portion 22) can be elastically deformed in a direction perpendicular to the inner surface of the airway (pharynx P), a burden on the living tissue that is a contact target is reduced. It can be reduced, and can be deformed so that the movement is not hindered when the necessary biological movement to block the airway acts.

  Moreover, since the 1st axial part 11 has the hole 14 penetrated to an axial direction, the side by which the 1st control part 12 of the 1st axial part 11 is provided by inserting the wire member 41 in the hole 14. The deformation of the first restricting portion 12 can be operated from the opposite side. For this reason, the 1st control part 12 is easily deformed from the opposite side to the side where the 1st control part 12 of the 1st axis part 11 is provided in the approximately straight line shape which can pass through the penetration hole formed in soft palate SP. It becomes possible, and attachment and removal of the 1st instrument 10 become easy. The hole 14 may not be in the form of a through-hole penetrating the first shaft portion 11 as long as the wire member 41 can be inserted. For example, the hole portion 14 is formed on the side surface of the first shaft portion 11. It may be a groove.

  Further, the restricting portions (the first restricting portion 12 and the second restricting portion 22) have a gap portion (the first gap portion 18 and the second gap portion 29) penetrating in a direction along the inner wall surface of the airway (pharynx P). Therefore, air can flow through the gap, and the first restricting portion 12 and the second restricting portion 22 themselves can be prevented from obstructing breathing.

Moreover, since the 2nd control part 22 is removable from the 2nd axial part 21, the 2nd control part 22 can be attached only at the time of sleep by the patient himself and can be removed except at the time of sleep, and a burden on a patient is reduced. Can improve the quality of life. Moreover, since it is not necessary to remove the 2nd axial part 21 from a biological tissue when removing the 2nd control part 22, it becomes easy to attach the 2nd control part 22 again.
Second Embodiment

  The medical device according to the second embodiment of the present invention is different from the medical device according to the first embodiment in the form of the first instrument 50 attached to the soft palate SP. In addition, in order to avoid duplication, the description which abbreviate | omits duplication is attached | subjected to the site | part which has the same function as 1st Embodiment.

  As shown in FIG. 15, the first instrument 50 in the second embodiment includes a first shaft portion 51 inserted through the soft palate SP from the oral cavity BC to the pharynx P, and an end of the first shaft portion 51 on the pharynx P side. A first restricting portion 52 that is connected to the portion and disposed in the pharynx P, and a first fastening portion 53 that is connected to the end portion of the oral cavity BC of the shaft portion and disposed in the oral cavity BC. In addition, the 1st instrument 50 in 2nd Embodiment is 1st only in the point by which the hole 14 is not formed in the 1st axial part 51 and the 1st fastening part 53, and the recessed part 17 is not formed in the 1st control part 52. Unlike the first instrument 10 in the embodiment, other configurations are common. The second instrument in the second embodiment is the same as the second instrument 20 in the first embodiment.

  Next, a method for attaching the first instrument 50 to the soft palate SP will be described. When attaching the first instrument 50 to the soft palate SP, an attachment jig 60 shown in FIG. 16 is used. The attachment jig 60 includes a holding jig 61 that holds the first instrument 50 and a puncture member 70 for forming a through hole in the soft palate SP.

  The holding jig 61 is formed at a columnar beam portion 64, an extension portion 65 extending from the beam portion 64 in the axial direction of the beam portion 64, and an end portion of the extension portion 65, and a part of the circumferential direction is formed. A notched annular gripping portion 66. As shown in FIG. 17, the first fastening portion 53 can be accommodated between the beam portion 64 and the grip portion 66, and the grip portion 66 moves the first shaft portion 51 from the cutout portion 67. It can be accommodated so as to surround the first shaft portion 51. The holding jig 61 is different from the holding jig 42 in the first embodiment only in that the insertion hole 43 is not formed in the beam portion 64, and the other configuration is common.

  The puncture member 70 is formed in a cylindrical shape in which a sharp puncture blade 71 is provided at the end, and the first instrument 50 held by the holding jig 61 is held in the holding hole 72 formed inside. 61 can be accommodated.

  When attaching the first instrument 50 to the soft palate SP, as shown in FIG. 17A, the first fastening portion 53 is disposed between the beam portion 64 and the grip portion 66 of the holding jig 61, and the notch portion is formed. The first shaft part 51 is accommodated in the grip part 66 from 47 and the first instrument 50 is held by the holding jig 61. Next, the first instrument 50 held by the holding jig 61 is accommodated in the accommodation hole 72 of the puncture member 70 together with the holding jig 61. At this time, the first restriction member 52 can be accommodated in the accommodation hole 72 of the puncture member 70 by elastically deforming the first bending member 15 that is curved in a natural state in a substantially linear shape.

  Next, as shown in FIG. 18, the puncture member 70 is inserted into the oral cavity BC through the mouth, and the puncture blade 71 is inserted into the soft palate SP from the oral cavity BC side to penetrate to the pharynx P side. As shown in FIG. 17B, the holding jig 61 is held so as not to move after the first restricting portion 52 passes through the soft palate SP and reaches the pharyngeal P side inside the puncture member 70. Further, only the puncture member 70 is retracted until the first instrument 50 is completely exposed from the puncture member 70. If the 1st control part 52 is exposed from the puncture member 70, as shown in FIG. 19, the 1st control part 52 which deform | transformed into the substantially linear shape will return to an original shape. Thereafter, when the holding jig 61 is moved laterally so as to remove the first shaft portion 51 from the notch 67 of the holding jig 61, the first instrument 50 is removed from the holding jig 61, and the first The soft palate SP is sandwiched between the retaining portion 53 and the first restricting portion 52, and the installation of the first instrument 50 is completed. By repeating this operation, a predetermined number (three in this embodiment) of the first instruments 50 can be attached to the soft palate SP.

Also by the medical device which concerns on 2nd Embodiment, the 1st control part 52 of the 1st instrument 50 is connected with the edge part of the 1st axial part 51, and is arrange | positioned in an airway, Opposing the site | part arrange | positioned in an airway Since the obstruction of the airway is regulated by contacting the surface, the obstruction of the airway by the tissue constituting the airway such as the soft palate SP and the tongue T can be more effectively suppressed.
<Third Embodiment>

  The medical device according to the third embodiment of the present invention is different from the medical device according to the first embodiment in the form of the first instrument 50 attached to the soft palate SP.

  As shown in FIG. 20, the first instrument 150 in the third embodiment includes a linear first shaft portion 151 that is inserted through the soft palate SP from the oral cavity BC to the pharynx P, and the pharynx P of the first shaft portion 151. A first restricting portion 152 that is connected to the end portion on the side and disposed in the pharynx P, and a first retaining portion 153 that is connected to the end portion of the oral cavity BC and disposed in the oral cavity BC. ing. The first shaft portion 151, the first restricting portion 152, and the first fastening portion 153 are formed by forming a single tubular body having a hole 154, and by inserting a linear member into the inside. The whole is elastically deformed linearly and can be restored to its original shape by pulling out the linear member. The end of the tubular body on the first regulating portion 152 side is formed in a spherical shape so as not to damage the living tissue, but the shape is not limited as long as the living tissue is not damaged.

  The first restricting portion 152 is shaped so as to be spiral in a natural state where no external force acts, and the outer diameter D8 of the spiral is larger than the outer diameter D7 of the first shaft portion 151.

  Although the outer diameter D8 of the spiral of the 1st control part 152 in a natural state is not specifically limited, For example, it can be 1 mm-20 mm. Although the outer diameter D7 of the 1st axial part 151 is not specifically limited, For example, it can be 0.5 mm-5 mm. Although the thickness W3 in the natural state of a spiral is not specifically limited, For example, it can be set as 1 mm-20 mm.

  The first restricting portion 152 is elastically bent and deformable. Therefore, the thickness W3 in the direction orthogonal to the inner wall surface of the pharynx P can be changed. A first gap portion 158 that is a gap is formed between the tubular bodies constituting the first restricting portion 152. The first gap portion 158 is formed in the first restricting portion 152 so as to penetrate in the direction along the inner wall surface of the pharynx P. Therefore, air can be circulated in the first gap portion 158.

  The first fastening portion 153 is formed in a substantially spherical shape having an outer diameter D9 that is larger than the outer diameter D7 of the first shaft portion 151. The soft palate SP is sandwiched between the first retaining portion 153 having a larger outer diameter than the first shaft portion 151 and the first restricting portion 152, thereby preventing the first instrument 150 from falling off the soft palate SP. In addition, the shape of the 1st fastening part 153 will not be limited to a spherical shape, if the drop-off | omission of the 1st instrument 150 can be suppressed, For example, it can be set as a cylinder shape etc.

  As the material of the first instrument 150, materials such as polypropylene, polyethylene, polystyrene, ethylene vinyl acetate copolymer, polyvinyl chloride, polyurethane, polyisoprene, and natural rubber can be used, preferably silicone, stainless steel, NiTi, fluorine A material having high biocompatibility such as resin and zirconia is applied. It is also possible to coat the surface of the material with a biocompatible substance. In addition, the 1st instrument 150 may be formed with the same member as a whole, or a different material may be applied by a site | part.

  When attaching the first instrument 150 to the soft palate SP, the attachment jig 40 described in the first embodiment can be used. First, a separate needle member (not shown) is pierced into a portion into which the first shaft portion 151 of the soft palate SP is inserted, and a through hole penetrating from the oral cavity BC to the pharynx P is formed. Thereafter, as shown in FIG. 21A, a first fastening portion 153 is disposed between the beam portion 44 and the grip portion 46 of the holding jig 42, and the first shaft portion extends from the notch portion 47 to the grip portion 46. 151 is accommodated. Then, the wire member 41 is inserted into the insertion hole 43 of the beam portion 44 and pushed forward, and the wire member 41 is inserted into the first fastening portion 153, the first shaft portion 151, and the hole portion 154 of the first restricting portion 153. Thereby, the whole 1st instrument 150 is elastically deformed linearly. In addition, in order to insert easily by extra-oral operation, it is also possible to set it as the form which the 1st instrument 150 elastically deforms to the shape curved in the soft palate SP direction.

  Next, as shown in FIG. 22, the attachment jig 40 is inserted from the mouth, and the first instrument 150 is inserted into the through-hole formed in the soft palate SP from the first restricting portion 152 side. After the first restricting portion 152 passes through the soft palate SP and reaches the pharynx P side, and the first fastening portion 153 comes into contact with the soft palate SP, the wire member 41 is retracted to the proximal end side. As a result, as shown in FIG. 21B, the first restricting portion 12 that has been deformed into a substantially linear shape returns to its original shape. Thereafter, as shown in FIG. 23, when the holding jig 42 is moved laterally so as to disengage the first shaft portion 151 from the notch 47 of the holding jig 42, the first tool is moved from the holding jig 42. 150 is detached, and the installation of the first instrument 150 is completed with the soft palate SP sandwiched between the first retaining portion 153 and the first restricting portion 152. By repeating this operation, a predetermined number of first instruments 150 can be attached to different positions of the soft palate SP.

  When it is desired to remove the first instrument 150 from the soft palate SP, the holding jig 42 is inserted into the oral cavity BC from the mouth, and the first fastening part 153 is provided between the beam part 44 and the grip part 46 of the holding jig 42. And the first shaft portion 151 is accommodated from the notch portion 47 to the grip portion 46. Then, when the wire member 41 is inserted into the insertion hole 43 of the beam portion 44 and pushed forward, and the tip of the wire member 41 reaches the first restricting portion 153, as shown in FIG. It is elastically deformed in a substantially linear shape. Thereafter, when the mounting jig 40 and the wire member 41 are pulled out from the mouth while maintaining the state in which the first instrument 150 is elastically deformed in a substantially straight line, the entire first instrument 150 is formed in the soft palate SP. To the oral cavity BC side. Thus, by using the attachment jig 40, the first instrument 150 can be easily attached to or detached from the soft palate SP. Therefore, if a through-hole penetrating from the oral cavity BC to the pharynx P is formed in the soft palate SP, even the patient himself can easily attach or remove the first instrument 150.

  Also in the medical device according to the third embodiment, the first regulating portion 152 of the first instrument 150 extends from the end portion of the first shaft portion 151 and is disposed in the airway, and the opposing surface of the portion disposed in the airway Since the obstruction of the airway is regulated by being in contact with the airway, the obstruction of the airway due to the tissue constituting the airway such as the soft palate SP and the tongue T can be more effectively suppressed.

  In the third embodiment, the description of the second instrument attached to the tongue T is omitted, but the second instrument may have a structure having a spiral second restricting portion as with the first instrument 150.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the first restricting portion 12 and the second restricting portion 22 are elastically deformable, but may not be deformable.

  Further, in order to enable the second shaft portion 21 and the second restricting portion 22 to be connected in the second device 20 of the first embodiment, a connecting screw hole 26 is formed in the second fastening portions 23A and 23B, and the connection is made. Although the connecting screw portion 28 is formed in the portion 27 (see FIG. 6), the connecting screw portion is formed in the second fastening portions 23A and 23B, and the connecting screw hole is formed in the connecting portion 27. Good.

  Moreover, both the 2nd fastening part 81 fixed to the 2nd axial part 21, and the connection part 82 fixed to the 2nd control part 22 like the 2nd instrument 80 which is a modification shown in FIG. It is also possible to employ a configuration in which both are magnets, or one is a magnet and the other is a ferromagnetic that is attracted to a magnetic force, so that they are connected by a magnetic force. As the magnet, for example, a neodymium magnet, an alnico magnet, a samarium cobalt magnet, a ferrite magnet, MK steel, KS steel, or the like can be applied.

  Or like the 2nd instrument 90 which is another modification shown in FIG. 25, the hook-shaped projection part 91 is provided in the 2nd control part 22 side (or 2nd fastening part 23A, 23B side), and a 2nd fastening An engaging portion 92 that can engage the protrusion 91 is formed on the side of the portions 23A and 23B (or the second restricting portion 22), and may be connected to each other.

  Moreover, it is good also as a structure in which the 1st control part 12 of the 1st instrument 10 attached to the soft palate SP can be connected and removed with respect to the 1st axial part 11 similarly to the 2nd instrument 20 attached to the tongue T. . Moreover, the 2nd control part 22 of the 2nd instrument 20 attached to the tongue T does not need to be provided with the structure which can be connected and removed. Moreover, both the 1st instrument 10 and the 2nd instrument 20 do not necessarily need to be attached to a biological body.

  Moreover, as shown in FIGS. 26 and 27, a plurality of first devices 10 including the first shaft portion 11 and the first restricting portion 12 may be connected to each other. The plurality of first devices 10 are connected to each other by being hooked on the respective first fastening portions 13 in a state where an annular interconnection member 100 made of a stretchable elastic material is stretched so that a tension acts. ing. The material of the interconnection member 100 is, for example, silicone or polyurethane. Ethylene vinyl acetate copolymer, natural rubber and the like are applied. With such a configuration, due to the tension of the interconnecting member 100, the first fastening portion 13 receives a force in a direction in which the first fastening portions 13 approach each other, and the soft palate SP receives a force in a direction in which the pharynx P is expanded. In this way, by causing the plurality of first instruments 10 to function in conjunction with each other, airway obstruction due to tissues constituting the airway such as the soft palate SP and the tongue T can be more effectively suppressed. Note that the interconnecting member 100 may not be made of an elastic material, and may have a structure that imparts stretchability by a spring structure. Further, the interconnecting member 100 may be connected to the first restricting portion 12 instead of being connected to the first fastening portion 13 or the first shaft portion 11.

  Moreover, the 1st control part 111 may have a holding | maintenance part which can hold | maintain a liquid like the 1st instrument 110 which is another modification shown in FIG. For example, the first restricting portion 111 is formed in a porous shape, so that the lubricant supplied as a liquid can be held in a holding portion that is an infinite number of internal spaces. As the lubricant, for example, glycerol, surfactant, oil, petroleum wax (microcristan) and the like can be applied, but not limited thereto. By holding the lubricant in the first restricting portion 111, it is possible to reduce the load on the living tissue with which the first restricting portion 111 comes into contact. The lubricant can be easily applied to the holding portion from the nose or mouth using a spray or the like.

  Moreover, the 1st control part 121 does not need to be provided with the space | gap part penetrated in the direction in alignment with the inner wall face of an airway like the 1st instrument 120 which is another modification shown in FIG. The 1st control part 121 is formed in a flat disk shape, for example.

  In addition, as shown in FIG. 30, a cylindrical member 130 through which the first shaft portion 11 passes may be separately provided outside the first shaft portion 11 of the first instrument 10. The member 130 is attached to the through hole of the soft palate SP, and the first instrument 10 can be removed leaving the member 130. If the member 130 is provided, even if the first instrument 10 is removed, the through hole of the soft palate SP is not blocked, and it becomes easy to attach the first instrument 10 again.

  The attachment position of the medical device is not limited to the soft palate SP or the tongue T as long as it is a tissue constituting the airway, and may be the epiglottis, for example. The various forms described above can be applied in combination with each other. Therefore, the configuration applied to the first instrument can be applied to the second instrument, or the configuration applied to the second instrument can be applied to the first instrument.

10, 50, 110, 120, 150 first instrument,
100 interconnecting members,
11, 51, 151 First shaft portion (shaft portion),
12, 52, 111, 121, 152 First restriction part (regulation part),
14,154 holes,
18,158 First gap (gap),
20, 80, 90 second instrument,
21 2nd shaft part (shaft part),
22 2nd regulation part (regulation part),
29 Second gap (void).

Claims (7)

A shaft portion inserted into the living tissue constituting the airway;
A medical device, comprising: a regulating portion that is connected to an end portion of the shaft portion and disposed in the airway, and that restricts airway obstruction by contacting an opposing surface of a portion disposed in the airway.   The medical device according to claim 1, wherein the restricting portion is elastically deformable in a direction orthogonal to an inner wall surface of an airway.   The medical device according to claim 1, wherein the shaft portion has a hole portion penetrating in an axial direction.   The medical device according to any one of claims 1 to 3, wherein the restricting portion has a gap portion penetrating in a direction along the inner wall surface of the airway.   The medical device according to any one of claims 1 to 4, wherein a plurality of configurations including the shaft portion and the restriction portion are provided and connected to each other.   The medical device according to claim 1, wherein the restricting portion is removable from the shaft portion.   The medical device according to any one of claims 1 to 6, wherein the restricting portion includes a holding portion capable of holding a liquid.

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