JP6133464B1 - Otolaryngology needle, intratympanic drug injection needle - Google Patents

Abstract

In a treatment for injecting a drug into a tympanic chamber, a highly rigid injection needle is provided which causes little damage to the tympanic membrane and is less likely to cause a breakage accident in the ear canal. In the present invention, a needle tube includes a distal end portion having a needle tip at a distal end, a proximal end portion on a needle proximal side, and a connection portion that continuously connects the distal end portion and the proximal end portion. An otolaryngological injection needle, wherein the outer diameter of the distal end portion is smaller than the outer diameter of the proximal end portion and the outer diameter of the connecting portion, the outer diameter of the distal end portion is 0.3 mm or less, and The length of the tip is 1 mm or more and 3 mm or less. [Selection] Figure 1

Description

  The present invention relates to an otolaryngological injection needle, and more particularly to an injection needle suitable for injecting a drug into a tympanic chamber.

  Sudden deafness, tinnitus, or diseases such as Meniere's disease or inner ear dizziness significantly lower QOL (Quality of Life). Many doctors have made efforts to develop various treatments for these refractory diseases, and it is known today that treatments that administer corticosteroids (steroids) are particularly effective. ing. A part of sudden deafness of unknown cause is thought to be caused by viral infection and inner ear circulation disturbance, and steroids are effective in suppressing inflammation caused by viral infection and improving circulation. It is believed that. However, steroids are highly effective against diseases, but have the disadvantage of causing side effects. Systemic administration of steroids by swallowing drugs or infusions cannot be applied to patients with diseases such as diabetes, and there are cases where the effect on the ears is low due to low reach to the ears.

  Overcoming these shortcomings is steroid intratympanic injection therapy, which was directly infused into the middle ear cavity (tympanic chamber) by Eiji Sakata, Professor Emeritus of Saitama Medical University. In FIG. 5, the conceptual diagram in the case of performing this treatment with the conventional injection needle is shown. A syringe needle having a sufficiently long 23G (gauge), that is, a needle tube 20 having an outer diameter of 0.6 mm is connected to the syringe 10 to prepare a steroid such as dexamethasone or methylprednisolone. The eardrum is anesthetized with Xylocaine (registered trademark), which is a local anesthetic, in advance, and the injection needle is inserted into the ear canal EB to penetrate the eardrum EE, and about 0.5 mL of steroid is slowly injected into the tympanic chamber EC. At this time, it is necessary that the needle point does not damage the inner ear organs such as the ossicle EF and the cochlea EI. Steroids are filled into the tympanic chamber EC, but since the drug solution eventually flows out to the larynx through the ear canal ED, there is little possibility of side effects due to excessive retention.

  This treatment method has the advantage that the steroid reaches the inner ear organ with extremely high side effects and less side effects because the steroid is administered into the tympanic chamber through a needle inserted through the eardrum. However, in order to inject the needle into the ear canal that has a complex shape, avoid the ossicles, and inject the drug by inserting the needle into the eardrum so as not to damage the inner ear organ, skill of the doctor is necessary. is there. Also, steroid intratympanic infusion therapy is often performed multiple times, and there is a risk of puncture of the tympanic membrane or the like if the eardrum is unnecessarily damaged. In current clinical settings, the procedure may be performed using an existing injection needle such as a 25G (outer diameter 0.5 mm) caterane needle that is thinner than the above, but the injection needle is thin so as not to damage the eardrum. There is a risk of breakage when using, and there is a problem that the eardrum is damaged more than necessary when a thick injection needle is used to prevent breakage. In order to solve such a problem, an otolaryngological injection needle has been devised (for example, see Patent Document 1).

Japanese Patent No. 5215394

  However, the technique described in Patent Document 1 mainly relates to the shape of the tip of the needle, and the thickness is also 27 G (0.4 mm) to 29 G (0.33 mm), so that the tip portion avoids excessive damage to the eardrum. This is not appropriate.

  The present invention has been made in view of the above problems, and an object thereof is to provide an otolaryngological injection needle suitable for injecting a drug such as a steroid into the tympanic chamber.

  (1) In the present invention, the needle tube includes a distal end portion having a needle tip at the distal end, a proximal end portion on the needle proximal side, and a connection portion that continuously connects the distal end portion and the proximal end portion. The outer diameter of the distal end portion is smaller than the outer diameter of the proximal end portion and the outer diameter of the connecting portion, the outer diameter of the distal end portion is 0.3 mm or less, and Provided is an otolaryngological injection needle characterized in that the length of the tip is 1 mm or more and 3 mm or less.

  According to the invention described in (1) above, since the outer diameter of the tip of the needle tube is 0.3 mm or less, that is, 30 G (gauge) or less by the standard of the injection needle, the middle ear is penetrated through the eardrum with the injection needle. When injecting a drug into the cavity (tympanic chamber), the pain and damage to the tympanic tissue that the patient feels can be minimized. Moreover, since the outer diameter of the connection part and the base end part which are the needle | hook base side of a needle tube is thicker than the outer diameter of a front-end | tip part, rigidity becomes high and an injection needle breaks during an operation in a long external auditory canal of 30 mm-40 mm. There is a remarkable effect that accidents are unlikely to occur.

  (2) The present invention provides the otolaryngological injection needle as described in (1) above, wherein an outer diameter of the base end portion is 0.5 mm or more.

  According to the invention described in the above (2), the outer diameter of the base end portion of the needle tube is 0.5 mm or more, that is, the thickness of 25 G (gauge) or more in the standard of the injection needle. Strength can be secured, and the burden and mistakes in doctor's treatment can be reduced. There is an excellent effect.

  (3) The present invention provides the otolaryngological injection needle according to (1) or (2) above, wherein the length of the needle tube is 40 mm or more.

  Since the ear canal has a length of about 20 mm for newborns and about 30 mm for adults from the entrance to the eardrum, according to the invention described in (3) above, the drug is passed through the eardrum through the ear canal and the drug enters the tympanic chamber. An injection needle that can be injected can be realized.

  (4) In the present invention, any one of the above (1) to (3) is characterized in that the connecting portion is tapered and the outer diameter continuously changes from the distal end portion toward the proximal end portion. An otolaryngological injection needle as described above is provided.

  According to the invention described in the above (4), since a needle tube having a thin outer diameter can be realized as a whole, an injection needle capable of treating the middle ear and the inner ear can be provided through an outer ear canal having a diameter of about 7 mm in adults. Excellent effect.

  (5) The present invention provides the otolaryngological injection needle according to (5) above, wherein the ridge angle of the connecting portion is 8 degrees or more and 20 degrees or less.

  According to the invention described in the above (5), since the connecting portion can be shortened, there is an effect that the base end portion having high rigidity can be inserted deeply and is not easily broken.

  (6) The present invention provides the otolaryngological injection needle according to any one of the above (1) to (3), wherein the connecting portion is a step.

  (7) The otolaryngological injection according to any of (1) to (6) above, wherein the needle tube has a mark on the surface of the needle tube indicating the direction of the opening for discharging the medicine. Provide a needle.

  According to the invention described in (7) above, since the surgeon can know the direction of the opening for discharging the medicine, the medicine can be placed in an appropriate direction even in the tympanic chamber where the needle tip is hidden by the eardrum. The outstanding effect that it can discharge is produced.

  (8) The otolaryngological injection needle according to any one of (1) to (7) above, wherein a mark indicating a distance from the needle tip is provided on a surface of the needle tube. provide.

  According to the invention described in (8) above, it is possible to know how long the distal end portion of the tympanic chamber where the needle tip is hidden by the tympanic membrane is inserted. It has an excellent effect of avoiding the risk of damaging the organs in the inner ear.

  (9) The otolaryngological injection according to any one of (1) to (8), wherein the needle tube is provided with a marker fixed to the position of the connecting portion. Provide a needle.

  According to the invention described in (9) above, when the needle tip is hidden by the tympanic membrane, it is possible to know how long the tip is stuck in the tympanic chamber, so that the drug is injected into the tympanic chamber. In doing so, it has an excellent effect of avoiding the risk of damaging the organs in the inner ear.

  (10) The present invention provides the otolaryngological injection needle according to any one of the above (1) to (9), wherein the surface of the needle tube is coated with a hydrophilic polymer.

  According to the invention described in the above (10), since the surface of the needle tube having a small surface roughness can be realized, even if the needle contacts the ear canal when passing through the ear canal, the risk of damaging the ear canal can be reduced, In addition, when piercing the eardrum, there is an excellent effect that damage to the eardrum tissue by the needle surface can be reduced.

  (11) In the present invention, the shape of the cross section perpendicular to the axial direction of the distal end portion and the shape of the cross section perpendicular to the axial direction of the proximal end portion are annular, the central axis of the distal end portion, The otolaryngological injection needle according to any one of (1) to (10) above, wherein the central axis of the base end is not coaxial.

  According to the invention described in (11) above, since the central axis of the distal end portion and the central axis of the proximal end portion are not coaxial, when the doctor observes from the proximal direction of the needle during the operation, the needle tip of the distal end portion is Since the proximal end is less likely to be shaded and the needle tip can be easily seen, an excellent effect is achieved in that the injection needle can be inserted into a desired position of the eardrum.

  (12) In the present invention, the outer shape of the cross section perpendicular to the axial direction of the tip end portion and the outer shape of the cross section perpendicular to the axial direction of the base end portion are elliptical. An otolaryngological injection needle according to any one of (10) to (10) is provided.

  According to the invention described in (12) above, when the doctor observes from the proximal direction of the needle during the operation, the rotation of the needle tip can be easily understood, so it is determined whether the direction of the opening for discharging the medicine is appropriate. Excellent effect of being easy to do.

  (13) The present invention is an injection needle that pierces the tympanic membrane and injects a drug into the tympanic chamber, and the needle tube is on the tip side having a needle tip at the tip end that pierces the tympanic membrane, A proximal end portion for transporting a drug from the outside world to the distal end portion through the ear canal, and a connection portion that continuously connects the distal end portion and the proximal end portion, and the distal end portion is externally attached to reduce damage to the eardrum. The diameter is small and the length is short enough that the needle tip does not reach the inner ear organ. The outer diameter of the connecting portion and the outer diameter of the proximal end portion are thicker than the distal end portion and cannot be folded in the ear canal. An injection needle for injecting the drug into the tympanic cavity is provided.

  In the treatment of injecting drugs into the tympanic chamber, the needle is somewhat thick (outer diameter 0.65 mm or more, 23 G or more) in order to ensure the operability of the doctor and allow the long ear canal to pass through a complicated shape. Is desirable. However, considering the damage to the eardrum tissue when penetrating the eardrum, the thickness of the injection needle is preferably as thin as possible (outer diameter 0.3 mm or less, 31 G or less). According to the invention described in the above (13), there is an excellent effect that two contradictory problems can be overcome.

  According to the present invention, since the outer diameter of the distal end portion of the needle tube is 0.3 mm or less, that is, 30 G (gauge) or less by the standard of the injection needle, the drug penetrates the eardrum with the injection needle and enters the middle ear cavity (tympanic chamber). When injecting, the pain felt by the patient and damage to the tympanic tissue can be minimized. Also, since the outer diameter of the connection part and the base end part on the needle base side of the needle tube is thicker than the outer diameter of the distal end part, the rigidity becomes high, and an accident occurs in which the injection needle breaks during the operation in the long external ear canal of 30 mm to 40 mm. It has the remarkable effect of being difficult.

(A) It is explanatory drawing explaining the state which connected the injection needle for otolaryngology concerning 1st embodiment of this invention to the injection cylinder (outer cylinder). (B) It is a side view of the injection needle for otolaryngology concerning a first embodiment. (C) It is a side view of the injection needle for otolaryngology concerning a modification. It is a conceptual diagram explaining the chemical | medical agent injection | pouring operation | movement to the tympanic chamber by the injection needle for otolaryngology. (A) It is explanatory drawing of the injection needle for otolaryngology concerning 2nd embodiment of this invention which has the mark showing the direction of the opening part 70. FIG. (B) It is explanatory drawing of the injection needle for otolaryngology which has a marker fixed to the position of a connection part which concerns on 3rd embodiment of this invention. (C) It is an example of AA arrow sectional drawing in (B). (D) It is an example of AA arrow sectional drawing in (B). (A) It is explanatory drawing of the injection needle for otolaryngology concerning 4th embodiment. (B) It is a conceptual diagram explaining the chemical | medical agent injection | pouring operation | movement to a tympanic chamber using the injection needle for otolaryngology concerning 4th embodiment. It is a conceptual diagram explaining the chemical | medical agent injection | pouring operation | movement into the tympanic chamber by the conventional injection needle.

  Embodiments of the present invention will be described below with reference to the accompanying drawings. 1 to 4 are examples of embodiments for carrying out the invention, and in the drawings, the same reference numerals denote the same components.

  FIG. 1A shows a state in which the otolaryngological injection needle according to the first embodiment of the present invention is connected to an injection cylinder (outer cylinder) 40. The otolaryngological injection needle includes a needle tube 20 and a needle base 30, and is connected to the outer cylinder 40 by inserting the needle base 30 into a tapered portion of the outer cylinder 40. The needle tube 20 includes a flow path 110 inside, and the chemical solution is transported to a desired place through the flow path 110. By pulling the pusher 60, the drug solution is sucked into the outer cylinder 40 from a vial or the like, and by pushing the pusher 60, the drug solution is discharged from the opening 70 provided at the tip of the needle tube 20 (see FIG. 1B). To do.

  FIG. 1B is a side view of an otolaryngological injection needle. The needle tube 20 includes a distal end portion 80, a connection portion 90, and a proximal end portion 100 in order from the needle tip. The surface of the needle tube 20 is preferably coated with a hydrophilic polymer such as polyethylene oxide (PEO). Since the surface of the needle tube with low surface roughness can be realized, even if the needle touches the ear canal when passing through the ear canal, the risk of damaging the ear canal can be reduced, and also when piercing the eardrum, It has an excellent effect that it can reduce damage to the eardrum tissue. In order to reduce the surface roughness of the surface of the needle tube 20, techniques such as polishing and plating may be used.

  An opening 70 is provided at the distal end of the distal end portion 80 to discharge the medicine. The needle tube 20 includes a distal end portion 80 having a needle tip at the distal end, a proximal end portion 100 on the needle base 30 side, and a connecting portion 90 that continuously connects the distal end portion 80 and the proximal end portion 100. The outer diameter of the distal end portion 80 is smaller than the outer diameter of the proximal end portion 100 and the outer diameter of the connecting portion 90, the outer diameter of the distal end portion 80 is 0.3 mm or less, and the length B of the distal end portion 80 Is 1 mm or more and 3 mm or less. The outer diameter of the proximal end portion 100 is 0.5 mm or more, and the length of the needle tube 20 is obtained by combining the length B of the distal end portion 80, the length C of the connecting portion 90, and the length S of the proximal end portion 100. Is 40 mm or more.

  The outer diameter of the connection portion 90m is larger than the tip portion 80 except for the portion connected to the tip portion 80. Specifically, the tip 80 has a thickness of 31G (outer diameter 0.28 mm), and the base end has a thickness of 25G (outer diameter 0.5 mm). The distal end portion 80 and the proximal end portion 100 are continuously connected by a tapered connecting portion 90, and the outer diameter of the connecting portion 90 continuously changes from the distal end portion 80 toward the proximal end portion 100. The ridge angle θ of the connecting portion is desirably 8 degrees or more and 20 degrees or less (see FIG. 1B). Since the outer diameter of the distal end portion 80 of the needle tube 20 is 0.3 mm or less, that is, 30 G (gauge) or less by the standard of the injection needle, it penetrates the eardrum EE (see FIG. 5) with the injection needle, and the middle ear cavity (tympanic chamber) When injecting drugs into the EC, the patient's pain and damage to the tympanic tissue can be minimized. Moreover, since the outer diameter of the connection part 90 and the base end part 100 which are the needle base 30 side of the needle tube 20 is thicker than the outer diameter of the front-end | tip part 80, rigidity becomes high and injects intraoperatively in the ear canal EB which is 30 mm-40 mm long. There is a remarkable effect of making it difficult for accidents such as the needle to break.

Further, since the outer diameter largely changes at the connection portion 90, the connection portion 90 can be made compact, and the base end portion 100 can be inserted to the back accordingly. Since the connection part 90 can be shortened, the base end part 100 with high rigidity can be inserted to the back, and the effect that it does not break easily is produced.
FIG. 1C shows a modified example of the otolaryngological injection needle according to the first embodiment. In the present modified example, the connection portion 90 has almost no length C, and has a step as the connection portion 90 between the distal end portion 80 and the proximal end portion 100.

  FIG. 2 is a conceptual diagram illustrating an operation of injecting a drug into the tympanic chamber by an otolaryngological injection needle. An otolaryngological injection needle according to the first embodiment having a sufficient length is connected to the syringe 10 to prepare a medicine. The injection needle is inserted into the ear canal EB, penetrating the eardrum EE, and the drug is slowly injected into the tympanic chamber EC. At this time, the distal end portion 80 is as extremely thin as 31 G (outer diameter 0.28 mm), and thus does not cause excessive damage to the eardrum. And since the base end part 100 has sufficient rigidity with 25 G (outer diameter 0.5 mm), the possibility of breakage is low and the procedure can be performed safely.

  FIG. 3 (A) shows an explanatory diagram of an otolaryngological injection needle according to the second embodiment of the present invention. On the surface of the needle tube 20 of the otolaryngological injection needle according to the present embodiment, a mark 120 indicating the direction of the opening 70 for discharging the medicine is formed. The mark 120 may be formed by grooving or may be formed by laser marking. The position where the mark 120 is formed may be on the surface of the connecting portion 90, the surface of the base end portion 100, or the surface of the connecting portion 90. This mark 120 allows the surgeon to know the orientation of the opening 70 for discharging the medicine during the operation, so that even in the tympanic chamber EC where the needle tip 115 is hidden by the tympanic membrane EE, an appropriate direction can be obtained. It has an excellent effect that the medicine can be discharged. Of course, a mark indicating the direction of the cut surface of the needle may be formed on the side of the needle base 30 as in the blade surface mark 140 in FIG. 3A, or both the mark 120 and the blade surface mark 140 may be formed. good. In particular, in the steroid intratympanic injection therapy using the otolaryngological injection needle according to the present invention, the operator performs the procedure while observing the needle tip 115 through a jig called an otoscope having an inner diameter of about 6 mm. It is preferable that a mark 120 indicating the direction of the opening 70 is formed on the needle tube 20 that is visible at the same time. The mark 120 may be a mark that indicates the direction of the opening 70 and at the same time indicates the length from the needle tip 115. When performing the procedure, it is possible to determine how long the needle tip 115 is inserted, so that there is a merit that it is easy to avoid danger.

  FIG. 3 (B) shows an explanatory diagram of an otolaryngological injection needle according to the third embodiment of the present invention. The needle tube 20 of the otolaryngological injection needle according to the present embodiment is provided with a marker 130 that is fixed at the position of the connecting portion. The marker 130 is preferably molded from a synthetic resin such as silicon rubber and has a through hole having a hole diameter that is the same as or smaller than the diameter of the tip 80. The marker 130 is inserted into the distal end portion 80 from the needle tip 115 and is fixed by the connecting portion 90 whose outer diameter is increased. When injection was performed on the eardrum EE, when the marker 130 hit the eardrum, the injection needle penetrated the eardrum EE by a length appropriate for the procedure. Since it can be seen how long the tip 80 is stuck inside the tympanic chamber EC where the needle tip 115 is hidden by the tympanic membrane EE, when the drug is injected into the tympanic chamber EC, the organ in the inner ear IE is moved. It has an excellent effect of avoiding the risk of injury. 3C and 3D show examples of a cross-sectional view taken along arrow AA in FIG. 3B in a cross section including the marker 130 and perpendicular to the needle tube 20. In FIG. 3C, the marker 130 has an annular cross section, and in FIG. 3D, the marker 130 has a rectangular shape with rounded corners. 3A and 3B, the connecting portion 90 has a tapered shape, but the connecting portion 90 may be a step as shown in FIG. 1C.

  FIG. 4 (A) shows an explanatory view of an otolaryngological injection needle according to a fourth embodiment of the present invention. The needle tube 20 includes a distal end portion 80, a connection portion 90, and a proximal end portion 100 in order from the needle tip 115. The needle tube 20 includes a flow channel 110 therein, and has at least one bent portion 210 in the middle of the base end portion 100. The length L from the needle tip 115 to the bent portion 210 is preferably about the length of the ear canal EB, that is, about 40 mm. By adopting such a structure, there is an advantage that the procedure becomes easy as will be described later.

  FIG. 4B describes an outline of a procedure using the otolaryngological injection needle according to the fourth embodiment having the bent portion 210 shown in FIG. The operating otoscope 150 generally includes a magnifying glass 170, an illuminating unit 160, and a specular 180. After the specular 180 is inserted into the ear canal EB, the magnifying glass 170 is used for the middle ear organ such as the eardrum EE or the inner ear organ. Perform the procedure while magnifying the image. Since the needle tube 20 has the bent portion 210, it is possible to insert the needle tube 20 into the ear canal EB from the side of the specular 180. Even when the distal end portion 80 is pierced into the eardrum EE, the observation and the technique are facilitated. Has an effect.

  The present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit and technical idea thereof. That is, in the above embodiment, the position, size, length, shape, material, orientation, and the like of each component can be changed as appropriate.

DESCRIPTION OF SYMBOLS 10 Syringe 20 Needle tube 30 Needle base 40 Outer cylinder 50 Gasket 60 Pusher 70 Opening part 80 Tip part 100 Base end part 110 Flow path 120 Mark 130 Marker 140 Blade surface mark 150 Operating ear mirror 160 Illumination part 170 Magnifier 180 Specular 210 Bending part EA Auricle EB External auditory canal EC Tympanic chamber ED Ear canal EE Tympanic membrane EF Octomy bone EG Semicircular canal EH Cochlear nerve EI Cochlear OE Outer ear ME Middle ear IM Inner ear

Claims (11)

Otolaryngological injection in which the needle tube is configured integrally with a distal end portion having a needle tip at the distal end, a proximal end portion on the needle proximal side, and a connecting portion that continuously connects the distal end portion and the proximal end portion A needle,
The outer diameter of the distal end is smaller than the outer diameter of the proximal end,
The outer diameter of the tip is 0.3 mm or less, and the length of the tip is 1 mm or more and 3 mm or less,
The connection portion is tapered, and the outer diameter of the connection portion increases from the distal end portion toward the proximal end portion within a range not exceeding the outer diameter of the proximal end portion. Otolaryngological needle to do.   The otolaryngological injection needle according to claim 1, wherein an outer diameter of the base end portion is 0.5 mm or more. The injection needle for otolaryngology according to claim 1 or 2 , wherein the length of the needle tube is 40 mm or more. The otolaryngological injection needle according to claim 3 , wherein the ridge angle of the connecting portion is not less than 8 degrees and not more than 20 degrees. The injection needle for otolaryngology according to any one of claims 1 to 4 , wherein there is a mark indicating a direction of an opening for discharging a medicine. The injection needle for otolaryngology according to any one of claims 1 to 5 , wherein a mark indicating a length from the needle tip is provided on a surface of the needle tube. The injection needle for otolaryngology according to any one of claims 1 to 6 , wherein the needle tube is provided with a marker that is fixed at a position of the connecting portion. The otolaryngological injection needle according to any one of claims 1 to 7 , wherein a surface of the needle tube is coated with a hydrophilic polymer. The shape of the cross section perpendicular to the axial direction of the distal end portion and the shape of the cross section perpendicular to the axial direction of the proximal end portion are annular.
The otolaryngological injection needle according to any one of claims 1 to 8 , wherein a central axis of the distal end portion and a central axis of the proximal end portion are not coaxial. Outer shape of a cross-section perpendicular to the axial direction of the tip, and any one of claims 1 to 9, wherein the outer shape of a cross-section perpendicular to the axial direction of the base end portion is elliptical The injection needle for otolaryngology according to claim 1. An injection needle that pierces the eardrum and injects a drug into the tympanic chamber,
Needle tube
A tip having a needle tip at the tip for piercing the eardrum;
A proximal end that is on the proximal side of the needle and transports the drug from the outside world to the distal end through the ear canal,
It is configured integrally with a connecting portion that continuously connects the distal end portion and the proximal end portion,
The outer diameter of the proximal end portion is formed to be thicker than the distal end portion, and the length of the distal end portion is formed such that the needle tip does not reach the inner ear organ in a state where the connection portion approaches the eardrum. And
The connection portion is tapered, and the outer diameter of the connection portion increases from the distal end portion toward the proximal end portion within a range not exceeding the outer diameter of the proximal end portion. An injection needle for injecting drugs into the tympanic cavity.