Ear surgery devices

Abstract

The present invention provides an ear surgery device, comprising a gripping portion and an insertion portion arranged in sequence, and a ventilation device movably arranged in the insertion portion. In the insertion portion, at least a portion of a suction tube and at least a portion of a push tube are accommodated in the outer sleeve, the push tube and the tubular body are sequentially sleeved on different parts of the outer wall of the suction tube along the extension direction of the outer sleeve, the suction tube is communicated with the interior of the tubular body to form a suction channel, and after the cutting member acts on the target tissue and before the ventilation device is placed in the incision, the tympanic effusion that has flowed out can be discharged through the suction tube through the suction channel, thereby avoiding the tympanic effusion that has flowed out blocking the ventilation device, and thus having good safety in use.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to an ear surgery device. Background Art

[0002] Many ear diseases, such as Eustachian tube obstruction, catarrhal otitis media, secretory otitis media, barotrauma media and aerotitis media can cause tympanic effusion, which requires timely drainage and targeted treatment.

[0003] The Chinese patent with publication number CN203898546U discloses a myringotomy suction knife. After the myringotomy is incised, the ear needs to be withdrawn, and then a tube placement tool is used to place a ventilation tube at the myringotomy incision to connect the inside and outside of the myringotomy, thereby achieving the purpose of fluid removal and ventilation. However, the sequential use of the myringotomy suction knife and the tube placement tool prolongs the operation time and increases the pain of the patient.

[0004] A Chinese patent with publication number CN206809388U discloses a myringotomy tube placement device, which can directly place a ventilation tube at the myringotomy incision without changing the tube placement tool after forming an incision in the tympanic membrane. However, if the myringotomy tube placement device forms an incision and the tympanic cavity effusion is discharged at the same time, it is easy to block the ventilation tube, affecting the subsequent discharge effect of the tympanic cavity effusion, and the use safety is low.

[0005] Therefore, it is necessary to develop a novel ear surgery device to avoid the above problems existing in the prior art. Summary of the invention

[0006] The purpose of the present invention is to provide an ear surgery device that can place a ventilation tube without replacing the tube placement tool after the tympanic membrane is incised, and can promptly discharge the tympanic cavity effusion that has flowed out while forming the incision to avoid blockage of the ventilation tube, and has good safety in use.

[0007] To achieve the above-mentioned purpose, the ear surgery device of the present invention includes a gripping portion and an insertion portion which are arranged in sequence, and a ventilation device movably arranged on the insertion portion, the gripping portion includes an adjusting member, the insertion portion includes an outer sleeve, a suction tube and a push tube, the ventilation device includes a tubular body, and the suction tube and the outer sleeve are coaxially arranged; a cutting member is arranged at the proximal end of the outer sleeve to act on the target tissue and form an incision, and the proximal end is defined as an end close to the target tissue; at least a portion of the suction tube and at least a portion of the push tube are accommodated in the outer sleeve, the push tube and the tubular body are sequentially sleeved on different parts of the outer side wall of the suction tube along the extension direction of the outer sleeve, and the suction tube is communicated with the interior of the tubular body to form a suction channel; the adjusting member is connected to the push tube to drive the push tube to move along the extension direction of the insertion portion and act on the tubular body, so that the ventilation device is placed in the incision.

[0008] The beneficial effect of the ear surgery device of the present invention is that: in the insertion part, at least a portion of the suction tube and at least a portion of the push tube are accommodated in the outer sleeve, and the push tube and the tubular body are sequentially sleeved on different parts of the outer wall of the suction tube along the extension direction of the outer sleeve, and the suction tube is communicated with the interior of the tubular body to form a suction channel, which can discharge the tympanic cavity effusion that has flowed out through the suction tube through the suction channel after the cutting member acts on the target tissue and before the ventilation device is placed in the incision, thereby avoiding the tympanic cavity effusion that has flowed out from clogging the ventilation device, thereby having good safety in use.

[0009] Preferably, the proximal end of the suction tube is accommodated in the tubular body, and the axial length between the proximal end of the suction tube and the proximal end of the outer sleeve is fixed and does not exceed 7 mm. The beneficial effect is that the suction tube is ensured to have a good suction effect without damaging the eardrum.

[0010] Preferably, at least part of the outer wall of the tubular body fits with the inner wall of the outer sleeve, and part of the inner wall of the tubular body fits with the outer wall of the suction tube, so that the tubular body produces elastic deformation and the suction channel has good sealing performance.

[0011] Further preferably, the surface roughness of the inner wall of the outer sleeve is not greater than 0.4, the surface roughness of the outer wall of the suction tube is not greater than 0.2, and the surface roughness of the inner wall surface and the outer wall surface of the push tube are both not greater than 0.2. The beneficial effect is that the push tube can smoothly act on the tubular body to place the ventilation device in the incision.

[0012] Further preferably, part of the outer wall and part of the inner wall of the outer sleeve from the proximal end are coated with a lubricating layer to further reduce the surface roughness, and the axial length of the lubricating layer along the extension direction of the outer sleeve is 25-35 mm.

[0013] Further preferably, the suction tube is made of one of polyamide, polypropylene and polyethylene, the outer sleeve is made of metal, and the tubular body is made of elastic material.

[0014] Preferably, the ventilation device further comprises a stopper, the stopper is arranged on the outer side wall of the tubular body, after the ventilation device is placed on the incision, the stopper is located on the outer side of the target tissue, the outer surface of the tubular body comprises a drug loading area, the drug loading area is located between the stopper and the proximal end of the tubular body. The beneficial effect is that the drug is conducive to playing an antibacterial and anti-inflammatory role on the environment inside the incision and the target tissue.

[0015] Further preferably, the drug-carrying area includes a plurality of groove structures, and the concave surfaces of the groove structures are loaded with drug coatings to prevent the drug coatings from falling off due to contact with the inner wall of the outer sleeve.

[0016] Further preferably, the drug coating is a drug controlled release coating for quantitatively releasing the drug.

[0017] Further preferably, the proximal end of the tubular body is provided with an oblique structure, which is inclined to the axis of the tubular body and has an outer diameter larger than the outer diameter of the tubular body, and the drug-loading area is also located on at least part of the front end face and at least part of the side face of the oblique structure.

[0018] Further preferably, the tubular body and the oblique-mouth structure are made of elastic and degradable materials, and before the push tube acts on the tubular body, the oblique-mouth structure is accommodated in the outer sleeve.

[0019] Further preferably, the proximal end of the tubular body is provided with an arc-shaped structure, which is perpendicular to the tubular body, and includes an arc-shaped concave surface and an arc-shaped convex surface, and the drug-loading area is also located at least a part of the arc-shaped concave surface, and the arc-shaped concave surface is opposite to the arc-shaped convex surface and is the proximal end of the arc-shaped structure.

[0020] Further preferably, the tubular body and the arc structure are made of elastic non-degradable materials, and before the push tube acts on the tubular body, the arc structure is accommodated in the outer sleeve, and a part of the arc convex surface fits with the inner wall of the outer sleeve.

[0021] Preferably, an outer side wall of the outer sleeve near the proximal end is provided with a developing structure, and the developing structure includes luminous scale markings to assist in determining the cutting depth and to assist in confirming the depth of the effusion while aspirating the effusion. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is a schematic structural diagram of the ear surgery device of the present invention;

[0023] Figure 2 for Figure 1 A schematic diagram of the structure of the outer sleeve shown;

[0024] Figure 3 It is a structural schematic diagram of the push tube of the present invention;

[0025] Figure 4 It is a schematic diagram of the structure of the suction tube of the present invention;

[0026] Figure 5 for Figure 1 A schematic diagram of the internal structure of the ear surgery device shown;

[0027] Figure 6 for Figure 1 Schematic diagram of the internal structure of the A1 part;

[0028] Figure 7 for Figure 6 The schematic diagram of the assembly structure of the outer sleeve and the ventilation device shown;

[0029] Figure 8 It is a structural schematic diagram of a ventilation device of the present invention;

[0030] Fig. 9 for Figure 8 The structural schematic diagram of the ventilation device shown in FIG.

[0031] Fig.10 It is a structural schematic diagram of another ventilation device of the present invention;

[0032] Fig.11 for Fig.10 The structure diagram of the ventilation device shown is after it is turned 180 degrees around the arc structure. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Unless otherwise defined, the technical terms or scientific terms used herein should be understood by people with general skills in the field to which the present invention belongs. "Including" and similar words used in this article mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects.

[0034] In view of the problems existing in the prior art, an embodiment of the present invention provides an ear surgery device, which includes a gripping portion and an inserting portion, and a ventilation device movably arranged on the inserting portion. The inserting portion includes an outer sleeve, a suction tube, and a pushing tube.

[0035] In the embodiment of the present invention, the proximal end of each component is defined as the end closest to the target tissue during the ear surgery process in which the ear surgery device is used.

[0036] The surface roughness of the embodiment of the present invention is represented by the profile arithmetic mean deviation Ra, which is specifically: the average value of the absolute value of the distance from each point on the actual profile to the profile centerline within the sampling length L.

[0037] Figure 1 Schematic diagram of the structure of ear surgery devices according to some embodiments of the present invention.

[0038] Reference Figure 1 The ear surgery device 1 includes a gripping portion 11 and an outer sleeve 12 which are arranged in sequence. The gripping portion 11 includes an adjusting member 111. The distal end of the gripping portion 11 is connected to a suction interface 13 to connect a suction device and discharge the accumulated fluid.

[0039] In some embodiments of the present invention, the adjusting member 111 is a push rod, and the push rod can move relative to the holding portion 11 along the extension direction of the holding portion 11 to drive the push tube accommodated in the outer sleeve 12 to move.

[0040] Figure 2 for Figure 1 Schematic diagram of the structure of the outer sleeve shown. Figure 3 Schematic diagram of the structure of the push tube of some embodiments of the present invention. Figure 4 Schematic diagram of the structure of the suction tube of some embodiments of the present invention.

[0041] Reference Figures 1 to 4The outer sleeve 12 is a hollow structure. At least a portion of the push tube 31 and at least a portion of the suction tube 41 are accommodated in the outer sleeve 12 .

[0042] In some embodiments of the present invention, part of the outer wall and part of the inner wall of the outer sleeve 12 starting from the proximal end are coated with a lubricating layer to further reduce the surface roughness.

[0043] Specifically, the lubricating layer (not shown in the figure) starts from the proximal end of the outer sleeve 12 and extends along the extension direction of the outer sleeve 12, that is, Figure 2 The axial length in the A2 direction shown is 25-35 mm.

[0044] The lubricating layer on the outer wall of part of the outer tube 12 is in direct contact with the target tissue when the ear surgery device 1 forms an incision and the ventilation device is inserted into the incision, which can reduce the pain caused to the patient during the process of puncturing the eardrum.

[0045] The lubricating layer on the inner wall of part of the outer sleeve 12 can effectively reduce the surface roughness between the outer sleeve and the ventilation device, so that the ventilation device can be more easily placed into the incision.

[0046] Figure 5 for Figure 1 Schematic diagram of the internal structure of the ear surgery device shown.

[0047] Reference Figure 5 The gripping portion 11 includes a guide member 51 and a fixing member 52. The adjusting member 111 is disposed between the guide member 51 and the fixing member 52. The distal end of the outer sleeve 12 is fixedly connected to the proximal opening of the gripping portion 11 to communicate with the interior of the gripping portion 11.

[0048] Reference Figure 4 and Figure 5 A portion of the suction tube 41 is received in the outer sleeve 12 , and another portion is received in the gripping portion 11 and fixedly connected to the fixing member 52 .

[0049] Specifically, the suction tube 41 includes a suction front section 411 and a suction rear section 412 connected in sequence, a part of the suction front section 411 is accommodated in the outer sleeve 12 and fixedly connected to the fixing member 52, the suction rear section 412 is accommodated in the holding portion 11, and the distal end is connected to the suction interface 13 and communicates with the interior of the suction interface 13, so that the tympanic cavity effusion is discharged from the ear surgery device 1 through the proximal end of the suction front section 411 through the suction front section 411 and the suction rear section 412 in sequence.

[0050] In some embodiments of the present invention, the front attraction section 411 and the rear attraction section 412 have the same constituent materials.

[0051] Reference Figure 5 A portion of the push tube 31 is received in the outer sleeve 12 , and another portion is received in the gripping portion 11 and movably connected to the guide member 51 .

[0052] Specifically, the distal end of the push tube 31 passes through the distal end of the outer tube 12 to enter the interior of the gripping portion 11, and the guide member 51 is movably connected to the push tube 31. The adjusting member 111 is fixedly connected to the push tube 31, and the fixing member 52 is fixedly connected to the suction tube 41. When the adjusting member 111 moves along the extension direction of the gripping portion 11, the push tube 31 is driven to move synchronously, and the guide member 51 can limit the movement direction of the push tube 31, so as to push the ventilation device to move smoothly along the extension direction of the outer tube 12 away from the outer tube 12.

[0053] In some embodiments of the present invention, one end of the guide member 51 is sleeved on the push tube 31 and is clearance-matched with the push tube 31 , and the other end is fixedly connected to the inner wall of the gripping portion 11 .

[0054] In some embodiments of the present invention, a cutting piece is disposed at the proximal end of the outer sleeve 12 .

[0055] In some embodiments of the present invention, the suction tube 41 is coaxially arranged with the outer sleeve 12 .

[0056] Figure 6 for Figure 1 Schematic diagram of the internal structure of part A1.

[0057] Reference Figure 6 The ventilation device 62 is movably disposed on the outer sleeve 12 , and a cutting member 61 is disposed at the proximal end of the outer sleeve 12 to act on the target tissue and form an incision. A portion of the suction tube 41 is accommodated in the outer sleeve 12 .

[0058] In some embodiments of the present invention, the cutting member 61 is a cutting blade.

[0059] Specifically, the proximal end of the suction tube 41 is received in the outer sleeve 12 , and the axial length D between the proximal end of the suction tube 41 and the proximal end of the outer sleeve 12 is a fixed value.

[0060] In some embodiments of the present invention, D does not exceed 7 mm.

[0061] In some embodiments of the present invention, D is 5.5-6.5 mm to ensure that the suction tube 41 has a good suction effect without damaging the eardrum.

[0062] On the one hand, if the D value is too large, it will affect the suction efficiency of the suction tube 41, causing excessive tympanic fluid to remain between the proximal end of the outer sleeve 12 and the proximal end of the suction tube 41, which is not conducive to the subsequent smooth discharge of tympanic fluid; if the D value is too small, at least a portion of the distal end of the suction tube 41 will extend out of the proximal end of the outer sleeve 12. Since the proximal end of the outer sleeve 12 needs to further be provided with the cutting piece, the extended suction tube 41 will affect the work of the cutting piece and even cause unnecessary damage to the tympanic membrane.

[0063] On the other hand, by accommodating the suction tube 41 in the outer sleeve 12 and making the opening of the suction tube 41 opposite to the opening of the outer sleeve 12, a larger volume of tympanic effusion can be absorbed at one time, thereby improving the discharge efficiency of the tympanic effusion and being able to quickly and effectively relieve the patient's pain.

[0064] Reference Figure 6 , a part of the push tube 31 is accommodated in the outer tube 12. The push tube 31 and the ventilation device 62 are sequentially sleeved on different parts of the outer wall of the suction tube 41 along the extension direction of the outer tube 12, so that the suction tube 41 is communicated with the interior of the ventilation device 62 to form a suction channel, which is conducive to absorbing a larger volume of tympanic effusion at one time and improving the discharge efficiency of tympanic effusion.

[0065] Specifically, refer to Figure 5 and Figure 6 The push tube 31 is movably mounted on the outer wall of the suction tube 41, so that it can move along the extension direction of the outer sleeve 12 under the drive of the adjusting member 111 and act on the ventilation device 62, so that the ventilation device 62 can move away from the outer sleeve 12 to be placed in the incision.

[0066] More specifically, during the process in which the push tube 31 acts on the ventilation device 62 until the ventilation device 62 is placed in the incision, the ventilation device 62 will not be separated from the outer tube 12, which means that even if the tympanic effusion is discharged while the incision is formed, it can be immediately discharged through the suction channel established between the ventilation device 62 and the suction tube 41, effectively preventing the tympanic effusion that has already flowed out from blocking the ventilation device 62, and having good safety in use. When the ventilation device 62 is placed in the incision, and the tympanic effusion that has flowed out after the incision is formed is discharged, the outer tube 12 is slowly moved away from the incision to separate from the ventilation device 62, that is, the implantation of the ventilation device 62 is completed, and the tympanic effusion generated in the ear subsequently will be promptly led out of the ear canal through the ventilation device 62.

[0067] Figure 7 for Figure 6Schematic diagram of the assembly structure of the outer sleeve and the ventilation device shown.

[0068] Reference Figure 7 The outer wall of the outer sleeve 12 is provided with a groove 73 communicating with the cutting edge surface 74 , and the ventilation device 62 is placed in the outer sleeve 12 through the groove 73 .

[0069] Specifically, refer to Figure 6 and Figure 7 The ventilation device 62 includes a stopper 71 and a tubular body 72, and the tubular body 72 accommodates the proximal end of the suction tube 41. The stopper 71 is arranged on the outer side wall of the tubular body 72, and the ventilation device 62 can be installed on the outer sleeve 12 and in a suitable position by adjusting the stopper 71. When the ventilation device 62 is placed in the incision, the stopper 71 is located outside the target tissue, that is, the stopper 71 does not pass through the incision.

[0070] In some embodiments of the present invention, at least part of the outer wall of the tubular body 72 fits with the inner wall of the outer sleeve 12, and part of the inner wall of the tubular body 72 fits with the outer wall of the suction tube 41, so that the tubular body 72 produces elastic deformation and the suction channel has good sealing performance.

[0071] Specifically, refer to Figure 6 and Figure 7 The outer wall of the ventilation device 62 near the proximal end is tightly fitted with the inner wall of the outer sleeve 12, and there is a gap between the remaining outer wall and the inner wall of the outer sleeve 12, so as to facilitate the ventilation device 62 to move smoothly toward the incision under the action of the pushing tube 31.

[0072] In some embodiments of the present invention, the gap between the remaining outer wall of the ventilation device 62 and the inner wall of the outer sleeve 12 is 0.2-0.4 mm.

[0073] In some embodiments of the present invention, the tubular body 72 is made of elastic material so that at least part of the outer wall of the tubular body 72 fits tightly against the inner wall of the outer sleeve 12 and part of the inner wall of the tubular body 72 fits against the outer wall of the suction tube 41, thereby generating the elastic deformation.

[0074] In some embodiments of the present invention, the surface roughness of the inner wall of the outer sleeve 12 is not greater than 0.4, the surface roughness of the outer wall of the suction tube 41 is not greater than 0.2, and the surface roughness of the inner wall surface and the outer wall surface of the push tube 31 are both not greater than 0.2, so that the push tube 31 can smoothly act on the tubular body 72 to place the ventilation device 62 in the incision.

[0075] In some embodiments of the present invention, the surface roughness of the inner wall of the outer sleeve 12 is not less than 0.1, the surface roughness of the outer wall of the suction tube 41 is not less than 0.1, and the surface roughness of the inner and outer wall surfaces of the push tube 31 are both not less than 0.1.

[0076] In some embodiments of the present invention, the inner wall and outer wall of the outer sleeve 12 have the same surface roughness, the inner wall and outer wall of the suction tube 41 have the same surface roughness, and the inner wall and outer wall of the push tube 31 have the same surface roughness.

[0077] In some embodiments of the present invention, the suction tube 41 is made of one of polyamide, polypropylene and polyethylene to facilitate the outflow of tympanic fluid and make it easy for the push tube 31 to move relative to the suction tube 41; the outer sleeve 12 is made of metal, which can play a good supporting role and can effectively constrain the relative movement direction of the push tube 31 and the suction tube 41.

[0078] Figure 8 Schematic diagram of the structure of a ventilation device according to some embodiments of the present invention. Fig. 9 for Figure 8 The structural schematic diagram of the ventilation device along direction B is shown.

[0079] Figure 8 In the ventilation device shown, the stopper 71 is provided at the middle of the outer wall of the tubular body 72 , and an oblique structure 81 is provided at the proximal end of the tubular body 72 , and the oblique structure 81 is inclined to the axis of the tubular body 72 .

[0080] Specifically, refer to Figure 8 and Fig. 9 The oblique structure 81 is a hollow cylinder surrounded by a front end face 811 and a rear end face 814 opposite to each other, and a side surface 813 and a side plane 812 located between the front end face 811 and the rear end face 814 .

[0081] Specifically, the stopper 71 is cylindrical and is arranged perpendicular to the axis of the tubular body 72, and the opening of the oblique structure 81 is connected to the inside of the tubular body 72. The outer diameter of the oblique structure 81 is larger than the outer diameter of the tubular body 72, so that after the oblique structure 81 passes through the incision, the outer sleeve 12 is operated to slowly move away from the incision to contact with the incision. Figure 8 During the separation process of the ventilation device shown in the figure, the cutout is always located between the stopper 71 and the oblique structure 81, ensuring Figure 8 The venting device shown will not slip out of the incision.

[0082] In some embodiments of the present invention, the tubular body 72 and the oblique structure 81 are made of elastic and degradable materials. Before the pushing tube 31 acts on the tubular body 72 , the oblique structure 81 is received in the outer sleeve 12 .

[0083] Specifically, refer to Figure 6 and Figure 8 The elastic deformation degree of the oblique structure 81 in the outer sleeve 12 is greater than the elastic deformation degree of the tubular column 72 in the outer sleeve 12, so as to ensure the sealing performance of the suction channel. The side plane 812 is provided and the oblique structure 81 is inclined to the axis of the tubular column 72, in order to reduce the elastic deformation degree of the oblique structure 81 as much as possible, so that the oblique structure 81 can quickly return to its original state after being separated from the outer sleeve 12.

[0084] In some embodiments of the present invention, referring to Figure 6 , Figure 8 and Fig. 9 ,when Figure 8 The ventilation device shown is accommodated in the outer sleeve 12, and the oblique structure 81 undergoes elastic deformation, so that the rear end face 814 is tightly fitted with the inner wall of the outer sleeve 12. There is a gap between the outer wall of the tubular column 72 and the inner wall of the outer sleeve 12, and part of the inner wall of the tubular column 72 is fitted with the suction tube 41 to achieve good sealing performance while undergoing elastic deformation.

[0085] In some embodiments of the present invention, the tubular body 72 and the oblique structure 81 are made of the same or different elastic degradable materials.

[0086] In some embodiments of the present invention, Figure 8 The ventilation device shown is composed of the elastic degradable material and is suitable for patients with mild ear diseases who need to be implanted for less than 3 months. The elastic degradable material will slowly decompose into water and carbon dioxide over a period of time and can be discharged through the Eustachian tube or the hole on the tympanic membrane, reducing the pain of removing the tube after the patient is cured.

[0087] Specifically, the elastic degradable material is at least one of polylactic acid (PLA), L-polylactic acid (PLLA), polyglycolic acid / polylactic acid copolymer (PGLA), polycaprolactone (PCL), polyhydroxylbutyratevalerate (PHBV), polyacetylglutamic acid (PAGA), polyorthoesters (POE) and polyethylene oxide / polybutylene terephthalate (PEO / PBTP), poly-p-dioxanone (PPDO), poly(butylene succinate) (PBS), poly(glycerol sebacate) (PGS), chitosan and polyvinyl alcohol vinylalcohol (PVA).

[0088] In some embodiments of the present invention, referring to Figure 8 and Fig. 9 The outer surface of the tubular body 72 includes a drug-carrying area 82, and the drug-carrying area 82 is located between the stopper 71 and the proximal end of the tubular body 72. The drug-carrying area 82 includes a plurality of groove structures (not shown in the figure), and the concave surface of the groove structure (not shown in the figure) is loaded with a drug coating to prevent the drug coating from falling off due to contact with the inner wall of the outer tube 12. The drug-carrying area 82 is conducive to the antibacterial and anti-inflammatory effects on the environment inside the incision and the target tissue through the drug.

[0089] Specifically, a removal process is performed on a portion of the outer surface of the tubular body 72 to form the groove structure.

[0090] More specifically, the groove structure is a hemispherical groove.

[0091] In some embodiments of the present invention, the drug loading region 82 further includes the front end face 811 and the side face 813. In other embodiments of the present invention, the drug loading region 82 further includes at least a portion of the front end face 811 and at least a portion of the side face 813.

[0092] In some embodiments of the present invention, the side plane 812 and the rear end surface 814 do not have the drug loading area 82 to avoid Figure 8 The ventilation device shown is housed in the outer sleeve 12 so that the drug-carrying area 82 contacts the inner wall of the outer sleeve 12, which may easily cause the risk of drug falling off.

[0093] In some embodiments of the present invention, the drug coating is a drug controlled release coating for quantitatively releasing the drug.

[0094] In some embodiments of the present invention, the drug control coating is composed of drugs and controlled-release components.

[0095] Specifically, the drug is a steroid anti-inflammatory drug or a derivative of the alcohol anti-inflammatory drug.

[0096] More specifically, the steroid anti-inflammatory drugs include 21-acetoxypregnenolone, alclometasone, algestrone, amcinonide, beclomethasone, betamethasone, budesonide, cloprednisone, clobetasol, clobetasone, clocortolone, clopredniol, corticosterone, cortisone, cortivazole, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednisone butyl, glycyrrhetinic acid, fluzacort, fluclosonide, flumethasone, fornisolide, fluocinolone acetonide, fluocinolone acetate, flucortolone butyl, fluocortolone, fluorometholone, fluperone acetate, fluprednidine acetate, At least one of foprednisolone, flurandrenolide, fluticasone propionate, aldehyde sedate, halcinonide, halobetasol propionate, halometasone, halopednisolone acetate, hydrocortisone, hydrocortisone, loteprednol edacarbon, mepividinolone, medrysone, methylprednisolone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, 25-diethylaminoprednisolone acetate, prednisolone sodium phosphate, prednisone, prednisolone valerate, ponilidine, rimexolone, tixocortolone, triamcinolone, triamcinolone acetonide, bentriamcinolone acetonide, flurandrenolide and hexamcinolone acetonide.

[0097] In some embodiments of the present invention, the controlled release component includes a hydrophilic degradable carrier and a hydrophobic carrier. The hydrophilic carrier, the hydrophobic carrier and the drug are mixed in proportion and loaded into the drug loading area 82. Figure 8 The ventilation device shown is placed in the incision, the hydrophilic carrier first slowly decomposes and releases the drug, and then the hydrophobic carrier slowly decomposes and releases the drug.

[0098] In some embodiments of the present invention, the hydrophobic carrier is composed of a degradable material. Figure 8 The ventilator device is shown to slowly release the drug while degrading.

[0099] Fig.10 Schematic diagram of the structure of another ventilation device according to some embodiments of the present invention. Fig.11 for Fig.10The structure diagram of the ventilation device shown is after it is turned 180 degrees around the arc structure.

[0100] Reference Fig.10 and Fig.11 , Fig.10 In the ventilation device shown, the proximal end of the tubular body 72 is provided with an arc structure 101, and the outer wall near the distal end of the tubular body 72 is provided with the stopper 71. The arc structure 101 is perpendicular to the tubular body 72 and has an arc concave surface 102 and an arc convex surface 103 opposite to each other, and the arc concave surface 102 is the proximal end of the arc structure 101.

[0101] In some embodiments of the present invention, Fig.10 In the ventilation device shown in the figure, the tubular body 72 and the arc structure 101 are made of elastic non-degradable materials. The push tube 31 acts on the tubular body 72, and the two ends of the arc structure 101 are respectively along Fig.11 The directions C1 and C2 shown are converged toward the axis of the tubular body 72 to be accommodated in the outer sleeve 12 , and a portion of the arcuate convex surface 103 is in contact with the inner wall of the outer sleeve 12 .

[0102] In some embodiments of the present invention, the tubular body 72 and the bevel structure 81 are made of the same or different elastic non-degradable materials.

[0103] In some embodiments of the present invention, Fig.10 The ventilation device shown is composed of the elastic non-degradable material and is suitable for patients with severe ear diseases and who need to be implanted for more than 3 months. The arrangement of the arc structure 101 is Fig.10 The ventilator device shown can be placed more stably in the incision without slipping off.

[0104] In some embodiments of the present invention, the elastic non-degradable material is medical silicone rubber.

[0105] In some embodiments of the present invention, the outer surface between the stopper 71 and the proximal end of the tubular body 72 and the arcuate concave surface 102 of the arcuate structure 101 have the drug-carrying area (not shown in the figure).

[0106] In some embodiments of the present invention, the arc-shaped convex surface 103 does not have the drug loading area to avoid Fig.10 The ventilation device shown is housed in the outer sleeve 12 so that the drug-carrying area contacts the inner wall of the outer sleeve 12, which may easily cause the risk of drug falling off.

[0107] In some embodiments of the present invention, the outer wall of the outer sleeve 12 near the proximal end is provided with a developing structure, and the developing structure includes luminous scale markings to assist in determining the cutting depth and assist in confirming the depth of the effusion while aspirating the effusion.

[0108] Specifically, the luminous scale markings are a plurality of circumferential scale markings formed around the outer wall of the outer sleeve 12. The plurality of circumferential scale markings are coated with a luminous coating.

[0109] Although the embodiments of the present invention are described in detail above, it is obvious to those skilled in the art that various modifications and variations can be made to these embodiments. However, it should be understood that such modifications and variations are within the scope and spirit of the present invention as described in the claims. Moreover, the present invention described herein may have other embodiments and may be implemented or realized in a variety of ways.

Claims

1. An ear surgery device, comprising a gripping portion and an inserting portion arranged in sequence, and a ventilation device movably arranged on the inserting portion, characterized in that: The holding portion includes an adjusting member, the inserting portion includes an outer sleeve, a suction tube and a pushing tube, the ventilation device includes a tubular body, and the suction tube and the outer sleeve are coaxially arranged; a cutting member is arranged at the proximal end of the outer sleeve to act on the target tissue and form an incision, and the proximal end is defined as an end close to the target tissue; at least a portion of the suction tube and at least a portion of the pushing tube are accommodated in the outer sleeve, and the pushing tube and the tubular body are sequentially sleeved on different parts of the outer side wall of the suction tube along the extension direction of the outer sleeve, and the suction tube is communicated with the inside of the tubular body to form a suction channel; the adjusting member is connected to the pushing tube to drive the pushing tube to move along the extension direction of the inserting portion and act on the tubular body, so that the ventilation device is placed in the incision; At least part of the outer wall of the tubular body is in contact with the inner wall of the outer sleeve, and part of the inner wall of the tubular body is in contact with the outer wall of the suction tube, so that the tubular body is elastically deformed and the suction channel has good sealing performance; The ventilation device further comprises a stopper, which is arranged on the outer side wall of the tubular body. After the ventilation device is placed in the incision, the stopper is located outside the target tissue. The outer surface of the tubular body comprises a drug-carrying area, which is located between the stopper and the proximal end of the tubular body. The proximal end of the tubular body is provided with an arc structure, and the outer wall near the distal end of the tubular body is provided with the stopper; the arc structure is perpendicular to the tubular body and has an arc concave surface and an arc convex surface opposite to each other, and the arc concave surface is the proximal end of the arc structure; or the proximal end of the tubular body is provided with an oblique structure; The tubular body and the oblique structure are made of elastic and degradable materials.

2. The ear surgery device according to claim 1, characterized in that: The proximal end of the suction tube is accommodated in the tubular body, and the axial length of the proximal end of the suction tube from the proximal end of the outer sleeve is fixed and does not exceed 7 mm.

3. The ear surgery device according to claim 1, characterized in that: The surface roughness of the inner wall of the outer sleeve is not greater than 0.4, the surface roughness of the outer wall of the suction tube is not greater than 0.2, and the surface roughness of the inner wall surface and the outer wall surface of the push tube are both not greater than 0.

2.

4. The ear surgery device according to claim 3, characterized in that: Part of the outer wall and part of the inner wall of the outer sleeve from the proximal end are coated with a lubricating layer to further reduce the surface roughness. The axial length of the lubricating layer along the extension direction of the outer sleeve is 25-35 mm.

5. The ear surgery device according to claim 3, characterized in that: The suction tube is made of one of polyamide, polypropylene and polyethylene, the outer sleeve is made of metal, and the tubular body is made of elastic material.

6. The ear surgery device according to claim 1, characterized in that: The drug-carrying area includes a plurality of groove structures, and the concave surfaces of the groove structures are loaded with drug coatings to prevent the drug coatings from falling off due to contact with the inner wall of the outer sleeve.

7. The ear surgery device according to claim 6, characterized in that: The drug coating is a drug controlled-release coating for quantitatively releasing drugs.

8. The ear surgery device according to claim 1, characterized in that: The proximal end of the tubular body is provided with an oblique structure, which is inclined to the axis of the tubular body and has an outer diameter larger than the outer diameter of the tubular body. The drug loading area is also located on at least part of the front end surface and at least part of the side surface of the oblique structure.

9. The ear surgery device according to claim 8, characterized in that: The tubular body and the oblique structure are made of elastic degradable materials. Before the push tube acts on the tubular body, the oblique structure is accommodated in the outer sleeve.

10. The ear surgery device according to claim 1, characterized in that: The proximal end of the tubular body is provided with an arc-shaped structure, which is perpendicular to the tubular body. The arc-shaped structure includes an arc-shaped concave surface and an arc-shaped convex surface. The drug-loading area is also located in at least a part of the arc-shaped concave surface. The arc-shaped concave surface is opposite to the arc-shaped convex surface and is the proximal end of the arc-shaped structure.

11. The ear surgery device according to claim 10, characterized in that: The tubular body and the arc-shaped structure are made of elastic non-degradable materials. Before the push tube acts on the tubular body, the arc-shaped structure is accommodated in the outer sleeve, and a part of the arc-shaped convex surface fits with the inner wall of the outer sleeve.

12. The ear surgery device according to claim 1, characterized in that: The outer wall of the outer sleeve near the proximal end is provided with a developing structure, and the developing structure includes luminous scale markings to assist in determining the cutting depth and assist in confirming the depth of the effusion while aspirating the effusion.

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