Disposable tympanic membrane and auditory meatus skin flap microscopic scalpel

Abstract

The invention relates to the technical field of medical instruments, in particular to a disposable tympanic membrane and auditory meatus skin flap microscopic scalpel which comprises a grab handle, an auditory meatus skin flap scalpel end and a puncture curette end, and the auditory meatus skin flap scalpel end and the puncture curette end are fixed to the two ends of the grab handle respectively. The perforated curette end comprises a main body axially fixed on the grab handle, a bent section fixed at the end part of the main body and an elliptical ring fixed at the end part of the bent section, the main body, the bent section and the elliptical ring are integrally formed, an included angle is formed between the bent section and the main body, and convex elliptical cutting edges are arranged on two surfaces of the elliptical ring; the ear canal flap knife end comprises a knife rod fixed on the grab handle and a blade fixed at the end part of the knife rod, the blade is provided with an arc-shaped cutting edge, and the tip end of the blade is provided with a sharp edge. The scalpel can give consideration to tympanic membrane repairing and auditory meatus flap cutting operation, achieves multiple purposes, has higher operation efficiency and convenience, and is high in safety and low in manufacturing cost; the cutter changing steps and time in the operation are effectively reduced, and the operation efficiency is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a disposable tympanic membrane, ear canal flap microsurgery knife. BACKGROUND

[0002] In the clinical diagnosis and treatment of otolaryngology, tympanic membrane repair, ear canal plasty and other middle ear and external ear canal minimally invasive surgery are the core means for treating tympanic membrane perforation, chronic otitis media, external ear canal stenosis and other diseases. Such surgery needs to be operated under the precise field of view of ear surgery microscope or ear endoscope, involving the separation of tympanic membrane epithelial layer and fibrous layer, the cutting and turning of ear canal flap, the precise placement of transplanted tissue and other key steps. The fine, safety and operation adaptability of surgical instruments are extremely high.

[0003] For example, in tympanic membrane repair surgery, the tympanic membrane in the ear canal is a very special membrane. It constitutes the outer wall of the middle ear, and the inside and outside are air, which can produce vibration and hearing. When the tympanic membrane is perforated due to external force compression, piercing, inflammation, etc., it is like a large drum that is no longer making a drum sound, and people can no longer hear the sound. After the tympanic membrane is perforated, the middle ear tissue will undergo inflammatory pathological changes and is also susceptible to infection from the outside world, so the best way is to repair the tympanic membrane. Tympanic membrane repair surgery will use a special instrument to separate the edges of the tympanic membrane perforation under a microscope or ear endoscope, creating a grafting wound, and then applying the prepared temporalis fascia, cartilage membrane and other repair materials to the grafting wound.

[0004] The prior art "a dual-purpose tympanic membrane repair ear knife" (publication number: CN215875207U) discloses a knife head structure that is circular as a whole, and has a small protrusion on the top of the knife head, so that the top of the knife head forms a friction surface, and the sharp knife edge can be used as a ring cutter to perform tympanic membrane incision operation, and the friction surface can replace the hook needle to make a tympanic membrane grafting wound. This ear knife improves the structure of the knife head, expands the function, reduces the operation steps, and shortens the operation time. However, the prior art still has the following technical problems: In the repair operation of the tympanic membrane perforation, the residual edge of the tympanic membrane at the edge of the perforation needs to be scraped off to facilitate the repair of the tympanic membrane. However, the cutting edge of the ear knife in the prior art is arranged at the tip of the knife head, only the part of the cutting edge is sharper, and the friction surface formed by the protrusions arranged on the plane of the knife head makes the edge of the knife head relatively blunt. Therefore, the edge of the knife head is not conducive to scraping and peeling operation, and the direction of the cutting edge is arranged towards the tip. In order to complete the scraping and peeling operation, the direction of the cutting edge needs to be adjusted repeatedly when scraping the edge of the tympanic membrane perforation. The overall operation steps are complex and the efficiency is very low. In addition, the small protrusions arranged on the plane of the knife head form a friction surface. When cutting, the protrusions on the friction surface are easy to repeatedly rub with the tissue at the incision, causing tissue damage and affecting postoperative healing. Since the ear knife needs to be inserted into the ear canal, the overall size of the knife head needs to be designed very small. In such a small knife head, smaller protrusions are arranged, which is difficult to manufacture and high in cost, and is not conducive to production. SUMMARY

[0005] The present application provides a disposable tympanic membrane, ear canal flap microsurgery knife, which can solve the problems of complex operation of the ear knife in the prior art, low surgical efficiency, and high manufacturing difficulty and cost.

[0006] The present application provides the following technical scheme: a disposable tympanic membrane, ear canal flap microsurgery knife, comprising a handle and an ear canal flap knife end and a puncture scraping spoon end fixed at both ends of the handle, respectively; The puncture scraping spoon end comprises a main body axially fixed on the handle, a bent section fixed at the end of the main body, and an elliptical ring fixed at the end of the bent section. The main body, the bent section and the elliptical ring are integrally formed. An angle is arranged between the bent section and the main body. The elliptical ring is provided with protruding elliptical cutting edges on both surfaces. The ear canal flap knife end comprises a knife rod fixed on the handle and a blade fixed at the end of the knife rod. The blade is provided with an arc-shaped cutting edge, and the tip of the blade is provided with a sharp blade.

[0007] Advantages: 1. Improve the operation efficiency. In the tympanic membrane repair operation of the ear knife in the prior art, the residual edge of the tympanic membrane perforation edge and the epithelial tissue are scraped and peeled off. The operation steps are complex and the efficiency is very low. The elliptical ring of the puncture scraping spoon end in the present application is provided with elliptical cutting edges on both surfaces. The elliptical ring can be rotated to scrape the edge of the tympanic membrane perforation in a circumferential direction. The double-sided blade structure of the elliptical ring enables each surface to have double blades for scraping when rotating. Compared with the circular edge in the prior art, the elliptical ring has more contact surfaces and a larger scraping area. Therefore, the scraping and peeling efficiency and the flatness of the perforation edge can be improved, the difficulty of scraping operation can be reduced, the operation time can be saved, the operation efficiency can be improved, and the perforation repair can be facilitated.

[0008] 2. High ease of use. The oval ring is thinner than a circle, which helps to enter and exit the ear canal and makes it easier to operate. In addition, the oval hole in the middle of the oval ring can adhere the tissue to the oval hole after scraping, forming a temporary storage space for the tissue. This makes it easier to remove the tissue from the ear canal after scraping, further improving the ease of operation.

[0009] 3. High safety. Compared to the existing technology where the blade tip is set at the tip, the elliptical blade of this design is a ring shape with the ends connected, which makes it less likely to cut the tissue and skin inside the ear canal during scraping operations, effectively improving operational safety.

[0010] 4. Multi-functional design enhances practicality. This design also features an ear canal flap cutting tip at the other end of the handle. The blade at this tip can cut the ear canal flap, and the curved cutting edge reduces cutting resistance. The sharp edge of the blade also facilitates puncture operations. The combination of the sharp edge and the curved cutting edge allows for more precise and neat incision of the ear canal flap. This makes the scalpel multi-functional, effectively improving practicality, reducing the number of blade changes and time required during surgery, and increasing surgical efficiency.

[0011] Furthermore, the tool holder and the blade are made of high-carbon steel.

[0012] Beneficial effects: Since the blade needs to be used for cutting, ensuring its sharpness is essential for a neater edge when cutting the ear canal flap. The use of high-carbon steel ensures sharpness. Compared to conventional stainless steel scalpels, this scalpel can prevent flap tearing or even damage to important structures caused by uneven or insufficient incisions, thus avoiding affecting the surgical process and promoting postoperative wound healing. Furthermore, high-carbon steel is less expensive than stainless steel, facilitating mass production. It can be directly discarded and recycled after each use, reducing costs and avoiding the need for repeated sterilization, which can reduce blade sharpness.

[0013] Furthermore, the connection between the blade and the shank has a cut mark, the diameter of which is smaller than the diameter of the shank.

[0014] Beneficial effects: The small diameter of the stab mark creates a structural weak point. Medical staff only need to apply a moderate bending force to the blade handle during retrieval to ensure precise breakage along the stab mark. The blade can then be placed separately in a puncture-proof sharps container to prevent injury to medical staff during retrieval. This design simplifies sharps separation, reduces retrieval steps, and improves the efficiency of sharps sorting and retrieval; it also enhances the safety and convenience of the sharps retrieval process.

[0015] Further, the handle is also provided with a rotation adjusting mechanism for controlling the rotation of the perforation curette end, the rotation adjusting mechanism comprising a support assembly fixed on the handle, a driving assembly and a locking assembly, the support assembly being used for supporting the main body; the driving assembly being used for driving the main body to complete the rotation, and the locking assembly being used for locking the main body.

[0016] Beneficial effects: the support assembly is used for supporting the main body, improving the stability of the rotation of the main body; the driving assembly can drive the rotation of the main body, so that the angle of the elliptical edge of the elliptical ring can be adjusted to scrape the tissue at the edge of the perforation; the locking assembly is used for preventing the axial rotation of the main body, and can be suitable for some axial scraping operations, the rotation adjusting structure makes the instrument more accurately adapt to the individualized surgical requirements, and significantly improves the surgical efficiency.

[0017] Further, the support assembly comprises a support column and a conical column fixed in sequence at the end of the handle, both ends of the support column form mounting chambers with the handle and the conical column respectively, and both mounting chambers are provided with bearings, the rod part of the main body is fixed between the inner rings of the two bearings, and the rod part of the bearing is rotationally connected with the support column.

[0018] Beneficial effects: the mounting chambers formed by the two ends of the support column respectively abutting with the handle and the conical column can stably encapsulate the two bearings, the double bearings form radial limiting from different positions of the main body, which greatly reduces the friction resistance of the rotation of the main body, avoids the rotation jamming of the main body, provides a stable support basis for the rotation of the perforation curette end, and improves the safety of the surgical operation.

[0019] Further, the driving assembly comprises a driven gear fixed at the tail end of the main body and a dial wheel engaged with the driven gear, the dial wheel is rotationally connected to the handle, and the driven gear is located inside the handle, and the dial wheel protrudes from the outer surface of the handle.

[0020] Beneficial effects: the driven gear is fixed at the tail end of the main body and built-in the handle, which can be used for stably transmitting the power of the dial wheel to the main body; the dial wheel is rotationally connected to the handle and protrudes from the outer surface of the handle, so that the doctor can lightly dial the protruding dial wheel by fingertips with one hand during the operation, and drive the rotation of the elliptical ring to realize the scraping and stripping action by means of the gear engagement transmission to drive the driven gear and the connected main body to rotate synchronously, the transmission characteristics of the gear engagement can accurately control the rotation amplitude, avoid the over-adjustment or deviation of the angle, and greatly improve the operation efficiency and stability of the angle adjustment.

[0021] Further, the locking assembly comprises a spring, a sliding block and a lever arranged in the handle, the spring and the sliding block are coaxially arranged with the main body, the handle is provided with a mounting groove, the spring is located at the bottom of the mounting groove, the sliding block is slidingly connected in the mounting groove, and the sliding block is located between the spring and the driven gear, and the end faces of the sliding block and the driven gear in opposite directions are both fixed with rubber rings; one end of the lever is fixed perpendicularly on the outer circumference of the sliding block, and the other end of the lever extends to the outer circumference of the handle, and the handle is provided with a avoiding groove for the lever to slide axially along the handle.

[0022] Beneficial effects: The spring and the sliding block are coaxially arranged in the mounting groove, and under normal circumstances, the spring pushes the sliding block to approach the driven gear, so that the rubber rings on the opposite ends of the sliding block and the driven gear are tightly fitted, and the friction between the rubber rings is used to quickly lock the driven gear and the connected main body, which helps to improve the stability of the main body during the axial scraping action in the operation; when the angle needs to be adjusted, the doctor can use the knuckle side of the index finger or the middle finger of the single hand to push the lever, so that the lever slides axially along the avoiding groove, overcomes the spring force to pull the sliding block away from the driven gear, and separates the rubber rings to unlock, and after unlocking, the rotation angle of the main body can be adjusted by rotating the driving wheel with the thumb, and after the adjustment is completed, the lever is released, and the spring automatically resets to push the sliding block to lock again. The whole locking and unlocking process can be completed by one hand, which improves the safety and convenience of the instrument operation. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 It is the structure front view of the application.

[0024] Figure 2 It is Figure 1 The enlarged view of the end A of the middle ear canal flap knife.

[0025] Figure 3 It is Figure 1 The enlarged view and side view of the end C of the middle perforation curette.

[0026] Figure 4 It is Figure 1 The enlarged view of the rotation adjusting mechanism B in DETAILED DESCRIPTION

[0027] The following will be further described in detail through specific embodiments: The marks in the drawings of the specification include: blade 1, arc-shaped cutting edge 101, sharp blade 102, notch 103, guide rod 2, handle 3, main body 4, bending section 5, elliptical ring 6, elliptical cutting edge 601, driven gear 7, sliding block 8, rotating shaft 9, driving wheel 10, accommodating cavity 11, bearing 12, support column 13, conical surface column 14, spring 15, avoiding groove 16, lever 17.

[0028] Example one As Figures 1 to 4As shown in the drawings, the disposable tympanic membrane, ear canal flap microsurgery knife comprises a handle 3 and an ear canal flap knife end and a puncture curette end fixed at both ends of the handle 3, respectively.

[0029] As shown in the drawings, Figure 1 and Figure 2 The ear canal flap knife end comprises a knife rod fixed on the handle 3 and a blade 1 fixed at the end of the knife rod, and the center of the handle 3 is provided with a middle hole with internal threads, and the end of the knife rod is provided with external threads, so that the guide rod 2 can be fixed at the end of the handle 3 by threaded connection. As shown in the drawings, Figure 2 In this embodiment, the length of the blade 1 is 8 mm, and the width is 3 mm. The blade 1 is provided with an arc-shaped cutting edge 101, and the tip of the blade 1 is provided with a sharp edge 102. The connection between the blade 1 and the knife rod is provided with a knife mark, and the diameter of the knife mark is smaller than the diameter of the knife rod. The knife mark is a weak point due to the smaller diameter, and medical personnel only need to apply a moderate bending force to the knife rod during recycling to make the blade 1 accurately break along the knife mark, and then put the blade 1 into a puncture-proof sharp instrument box separately to avoid scratching the medical personnel during recycling. The material of the knife rod and the blade 1 is preferably high-carbon steel. Since the blade 1 needs to be cut, the sharpness ensures that the edges of the ear canal flap are more uniform when cut. The use of high-carbon steel material can ensure sharpness. Compared with conventional stainless steel surgical blade 1, this surgical knife can prevent uneven incisions or insufficient incisions from causing flap tearing or even important structure damage, which can affect the progress of the operation and is beneficial to wound healing after the operation. The cost of high-carbon steel is lower than that of stainless steel, which is conducive to mass production. It can be directly discarded and recycled after each use, which saves costs and avoids the situation of reducing the sharpness of the blade 1 caused by repeated disinfection and use.

[0030] As shown in the drawings, Figure 1 and Figure 3 The puncture curette end comprises a main body 4 fixed axially on the end of the handle 3, a bending section 5 fixed on the end of the main body 4, and an elliptical ring 6 fixed on the end of the bending section 5. The main body 4, the bending section 5 and the elliptical ring 6 are integrally formed, and an included angle is provided between the bending section 5 and the main body 4, and the included angle is in the range of 15°-30°, as shown in the drawings, Figure 3 The elliptical ring 6 is provided with a convex elliptical cutting edge 601 on both sides, and in this embodiment, the length of the major axis of the elliptical ring 6 is 3 mm, and the width of the minor axis is 2 mm.

[0031] As shown in the drawings, Figure 3 The handle 3 is also provided with a rotation adjusting mechanism for controlling the rotation of the puncture curette end. The rotation adjusting mechanism comprises a support assembly, a driving assembly and a locking assembly fixed on the handle 3. The support assembly is used to support the main body 4; the driving assembly is used to drive the main body 4 to complete the rotation action, and the locking assembly is used to stop the rotation of the main body 4.

[0032] The support assembly comprises a support column 13 and a conical column 14 fixed in sequence at the end of the handle 3, as shown in the figure. Figure 3 The support column 13 is provided with protrusions at both ends, and the protrusions at both ends of the support column 13 form mounting chambers with the handle 3 and the conical column 14, respectively. Bearings 12 are arranged in the mounting chambers. The rod portion of the main body 4 is fixed between the inner rings of the two bearings 12, and the rod portion of the bearing 12 is rotationally connected with the support column 13, so that the main body 4 can stably rotate. The protrusions at both ends of the support column 13 are connected with the handle 3 and the conical column 14 in a hole shaft connection mode, and are fixed in an interference fit manner.

[0033] The drive assembly comprises a driven gear 7 fixed at the tail end of the main body 4 and a dial wheel 10 engaged with the driven gear 7. The center of the dial wheel 10 is rotationally connected with a rotating shaft 9, both ends of the rotating shaft 9 are fixed on the arms in the accommodating cavity 11, and the outer circumference of the dial wheel 10 protrudes from the outer surface of the handle 3. The tail end of the driven gear 7 and the tail end of the main body 4 are located inside the accommodating cavity 11, and the driven gear 7 is fixed on the tail end of the main body 4 by a key connection. By rotating the dial wheel 10, the driven gear 7 can be driven to rotate.

[0034] The locking assembly comprises a spring 15, a sliding block 8 and a dial rod 17 arranged in the handle 3. The spring 15 and the sliding block 8 are coaxially arranged with the main body 4. The handle 3 is provided with a mounting groove, and the spring 15 is located at the bottom of the mounting groove. The sliding block 8 is slidingly connected in the mounting groove, and the sliding block 8 is located between the spring 15 and the driven gear 7. Rubber rings are fixed on the end faces of the sliding block 8 and the driven gear 7 in opposite directions by glue. One end of the dial rod 17 is fixed perpendicularly on the outer circumference of the sliding block 8, and the other end of the dial rod 17 protrudes from the outer circumference of the handle 3. The handle 3 is provided with an avoiding groove 16 for the dial rod 17 to slide axially along the handle 3.

[0035] The use method of the surgical knife is as follows: Holding the handle 3 with one hand, according to the surgical procedure, select the corresponding knife end operation, when the ear canal flap is cut, select the ear canal flap knife end of one end of the handle 3, use the sharp blade 102 of the blade 1 tip to accurately puncture to determine the starting point of the flap cutting, and then through the arc-shaped blade 101 to match the curved shape of the external auditory canal, along the preset path to complete the flap cutting at one time, the high-carbon steel material of the blade 1 can ensure that the incision edge is neat and avoid tearing the flap; When switching to the edge of the tympanic membrane perforation processing, without changing the instrument, only need to turn over the handle 3 to use the other end of the perforation spatula end, at this time, the holding state should ensure that the thumb is on the side of the driving wheel 10, and the remaining four fingers are on the side of the driving rod 17, then the angle between the bending section 5 and the main body 4 is used to make the oval ring 6 smoothly extend into the ear canal and match the edge of the tympanic membrane perforation, the knuckle side of the index finger or middle finger is used to drive the driving rod 17, so that it slides axially along the avoidance groove 16, overcomes the elastic force of the spring 15 to pull the sliding block 8 away from the driven gear 7, so that the rubber ring is separated and unlocked, after unlocking, the rotation angle of the main body 4 can be controlled by rotating the driving wheel 10 with the thumb, the oval blades 601 on both sides of the oval ring 6 can directly scrape the edge of the perforation, if it is necessary to fix the oval ring 6, the driving rod 17 can be loosened, the spring 15 will automatically push the sliding block 8 to approach the driven gear 7, the friction force generated by the close contact between the sliding block 8 and the rubber ring at the opposite end of the driven gear 7 locks the main body 4, and then the oval ring 6 remains stationary; During the scraping process, the oval hole in the middle of the oval ring 6 can temporarily store the residual edges or epithelial tissues scraped off by means of tissue viscosity, which is conducive to taking the tissues out of the ear canal and avoiding the residual tissues in the ear canal; During the entire surgical process, the instrument does not need to be frequently replaced, and the function of one knife with two uses is realized; After the operation is completed, when the sharp instrument is recovered, the medical staff can apply a moderate bending force to the blade 1 of the ear canal flap knife end, so that the blade 1 accurately breaks along the knife mark, and the broken blade 1 is placed in the puncture-proof sharp instrument box alone, and the remaining handle 3 and other components can be detached and disposed of as medical waste, completing the entire surgical operation and instrument recovery process. The above is only an embodiment of the present application, the present application is not limited to this embodiment. The specific structure and characteristics of the scheme are not described in detail. It should be noted that for those skilled in the art, without departing from the structure of the present application, a number of modifications and improvements can be made, which should be regarded as the protection scope of the present application, which will not affect the effect and practicality of the patent. The protection scope claimed in this application should be subject to the content of its claims, and the specific implementation mode and the like recorded in the description can be used to explain the content of the claims.

Claims

1. A disposable tympanic membrane and ear canal flap microsurgical scalpel, characterized in that: Includes a handle and an ear flap scalpel tip and a puncture curette tip, which are respectively fixed to both ends of the handle; The perforated scraper end includes a main body axially fixed to the handle, a bent section fixed to the end of the main body, and an elliptical ring fixed to the end of the bent section. The main body, the bent section, and the elliptical ring are integrally formed. There is an angle between the bent section and the main body. Both sides of the elliptical ring are provided with protruding elliptical cutting edges. The ear canal flap blade includes a blade fixed to a handle and a blade fixed to the end of the blade. The blade has an arc-shaped cutting edge and a pointed tip.

2. The disposable tympanic membrane and ear canal flap microsurgical scalpel according to claim 1, characterized in that: The tool holder and blade are made of high-carbon steel.

3. The disposable tympanic membrane and ear canal flap microsurgical scalpel according to claim 2, characterized in that: The blade has a cut mark at the connection between it and the shank, and the diameter of the cut mark is smaller than the diameter of the shank.

4. The disposable tympanic membrane and ear canal flap microsurgical scalpel according to claim 3, characterized in that: The handle is also provided with a rotation adjustment mechanism for controlling the rotation of the perforated scraper end. The rotation adjustment mechanism includes a support component, a drive component, and a locking component fixed on the handle. The support component is used to support the main body; the drive component is used to drive the main body to complete the rotation action; and the locking component is used to stop the main body from rotating.

5. The disposable tympanic membrane and ear canal flap microsurgical scalpel according to claim 4, characterized in that: The support assembly includes a support column and a conical column fixed sequentially to the end of the handle. The two ends of the support column form mounting chambers with the handle and the conical column, respectively. Each mounting chamber is equipped with a bearing. The rod of the main body is fixed between the inner rings of the two bearings, and the bearing rod is rotatably connected to the support column.

6. The disposable tympanic membrane and ear canal flap microsurgical scalpel according to claim 5, characterized in that: The drive assembly includes a driven gear fixed to the tail end of the main body and a turn wheel meshing with the driven gear. The turn wheel is rotatably connected to the handle, the driven gear is located inside the handle, and the turn wheel protrudes from the outer surface of the handle.

7. The disposable tympanic membrane and ear canal flap microsurgical scalpel according to claim 6, characterized in that: The locking assembly includes a spring, a slider, and a lever disposed within the handle. The spring and slider are coaxially arranged with the main body. The handle has a mounting groove, with the spring located at the bottom of the mounting groove. The slider is slidably connected within the mounting groove and is positioned between the spring and the driven gear. Rubber rings are fixed to the end faces of the slider and the driven gear in opposite directions. One end of the lever is vertically fixed to the outer circumference of the slider, and the other end of the lever extends to the outer circumference of the handle. The handle has a clearance groove for the lever to slide along the handle axis.

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