Regular bone window cutting and lacrimal passage supporting method based on ultrasonic bone taking trephine

Abstract

The invention discloses a bone window cutting system and method based on an ultrasonic bone taking trephine, belongs to the technical field of medical instruments, and is used for a chronic dacryocystitis (DCR) operation. The system comprises a bone taking trephine and a self-adaptive lacrimal passage silica gel support, the bone taking trephine is composed of 20 isosceles sawteeth which are evenly distributed, the cutting efficiency can be improved, the bone taking trephine is made of titanium alloy, the working frequency of the bone taking trephine is 3000 Hz or above, and the temperature of the bone taking trephine is smaller than or equal to 85 DEG C. The self-adaptive lacrimal passage silica gel support is made of silica gel materials, is of a split structure and comprises an umbrella-fabric-shaped upper cover body and a J-shaped lower cavity, and the upper cover body is provided with a needle hole inserting groove. The design of the bone taking trephine is optimized, the problems that an existing silica gel lacrimal passage support cavity is difficult to manufacture and the process is complex are solved, the bone cutting efficiency can be improved to form a regular bone window, the surgical bleeding amount and postoperative complications are reduced, and the safety and reliability of a chronic dacryocystitis surgery are improved.

Description

Technical Field

[0001] The invention provides a bone window cutting and lacrimal duct supporting method, belongs to the technical field, and particularly relates to a regular bone window cutting and lacrimal duct supporting method based on ultrasonic bone trephine. Background Art

[0002] Chronic dacryocystitis (DCR) surgery requires bone removal on the lateral nasal wall to form a channel to restore tear duct patency. The function of the bone window cutting device is to accurately remove bone and form a regular channel. Traditional bone window cutting mainly uses tools such as bone rongeurs, which remove bone through mechanical occlusion. However, this type of device will cause irregular bone window shape and heavy bleeding during surgery, which not only affects the surgeon's visual clarity and increases the difficulty of operation, but also causes postoperative reactive edema or anastomotic mucosal proliferation due to surgical trauma, resulting in adhesion of the new channel cavity wall or even re-blockage, seriously affecting the surgical effect.

[0003] Existing bone trephine drills are mostly made of steel or aluminum alloy, typically employing a simple cylindrical design. These materials have poor heat dissipation and biocompatibility, and the cylindrical structure is also weak in strength and adaptability, making it difficult to efficiently create a regular bone window during surgery. Furthermore, low energy transfer efficiency during cutting can lead to excessive bleeding and prolonged surgery. Furthermore, existing lacrimal duct silicone stents present challenges such as difficulty in cavity fabrication and complex manufacturing processes. They lack a structural design that effectively inhibits postoperative anastomotic mucosal proliferation and cannot adapt to the varying sizes of the lacrimal sac cavity. Summary of the Invention

[0004] In order to solve the above problems, the present application provides a regular bone window cutting and tear duct support method based on ultrasonic bone drilling, which solves the problems of irregular bone window cutting, excessive bleeding and many postoperative complications.

[0005] In order to solve the above technical problems, the present invention provides the following technical solution: a method for cutting a regular bone window and supporting the tear duct based on ultrasonic bone trephine, comprising the following steps:

[0006] (1) Using an ultrasonic bone drill to cut a bone window on the lateral nasal wall;

[0007] (2) Implanting the adaptive lacrimal silicone stent into the bone window channel;

[0008] (3) injecting filler into the lower cavity through the pinhole insertion slot of the stent to expand it to fit the size of the lacrimal sac cavity;

[0009] The ultrasonic bone trephine drill head is composed of 20 isosceles teeth evenly distributed around the center of the circle, with a tooth height of 0.5-1 mm and a tooth top angle of 30°-60°.

[0010] The self-adaptive lacrimal duct silicone stent comprises an upper cover body and a lower cavity of a split design:

[0011] The upper cover body is in the shape of an umbrella surface, and a needle hole insertion groove is provided at the top;

[0012] The lower cavity is a J-shaped circular tube, which is integrally composed of an elbow, a connecting head and a tapered head. The connecting head is in the shape of a circular ring column with a thin middle and thick ends;

[0013] The upper cover body and the lower cavity are fixedly bonded by medical silicone.

[0014] Preferably: The material of the ultrasonic bone cutting trephine is titanium alloy, the working frequency is above 3000Hz, and the working temperature ≤ 85°C.

[0015] Preferably: The included angle between the side edge of the isosceles serrations and the radial direction is 15°–45°, and an arc transition groove is provided at the root of the serrations to reduce stress concentration.

[0016] Preferably: The maximum outer diameter of the connecting head of the lower cavity is 3–5mm, the taper of the tapered head is 1:10–1:5, and the bending radius of the elbow is 2–4mm.

[0017] Preferably: The filling material is normal saline, degradable hydrogel or medical expansion material, and the volume of the lower cavity expands by 10%–30% after injection.

[0018] Preferably: The diameter of the umbrella surface of the upper cover body is 1.2–1.5 times the maximum outer diameter of the lower cavity, and the thickness of the edge of the umbrella surface is 0.2–0.5mm.

[0019] A system for implementing any of the methods of claims 1–6, comprising:

[0020] Ultrasonic bone cutting trephine unit: comprising a transducer, a horn and the serrated cutter head described in claim 1;

[0021] Adaptive lacrimal duct silicone stent unit: comprising a split upper cover body and a J-shaped lower cavity;

[0022] Host control unit: output high-frequency electric energy and monitor impedance matching.

[0023] Preferably: The horn is a stepped titanium alloy horn, and the amplitude magnification factor is 1.5–2.2 times.

[0024] Preferably: It also includes 3 types of bone cutting trephine models with different outer diameters (2.5mm / 3.5mm / 4.5mm) and 1 type of stent model (adapted to the bone window aperture of 4–6mm).

[0025] Preferably: A self-sealing silicone membrane is embedded in the needle hole insertion groove of the upper cover body, and the closing rate after puncture is ≥ 99%.

[0026] One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages:

[0027] Aiming at the problems of irregular bone window shape, large blood loss during cutting by existing bone rongeurs, difficulty in manufacturing the cavity of traditional lacrimal duct stents, and inability to inhibit the proliferation of anastomotic mucosa after surgery resulting in restenosis, this device realizes efficient and regular bone window cutting through 20 isosceles serrated cutter heads (serration height 0.5 - 1 mm, apex angle 30° - 60°) of an ultrasonic bone cutting trephine, combined with a split-type expandable silicone lacrimal duct stent (upper cover body with a needle hole insertion groove + J-shaped lower cavity body). During the operation, a filler is injected into the stent to make it expand by 10% - 30% to precisely fit the lacrimal sac cavity. The low-temperature cutting characteristic below 85°C of the titanium alloy ultrasonic trephine is used to reduce bleeding. At the same time, the physical support of the stent inhibits the proliferation of mucosa, finally shortening the bone window cutting time to within 10 minutes and significantly reducing the postoperative restenosis rate.

[0028] Other advantages, objectives and features of the present invention will be elaborated to some extent in the subsequent description, and to some extent, will be obvious to those skilled in the art based on the study of the following text, or can be taught from the practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a hierarchical relationship diagram of the core components of an ultrasonic bone cutting trephine system for a method of regular bone window cutting and lacrimal duct support based on an ultrasonic bone cutting trephine according to the present invention.

[0030] Figure 2 It is a full surgical flow chart of a method of regular bone window cutting and lacrimal duct support based on an ultrasonic bone cutting trephine according to the present invention.

[0031] Figure 3 It is an energy transfer diagram of a system for a method of regular bone window cutting and lacrimal duct support based on an ultrasonic bone cutting trephine according to the present invention.

[0032] Figure 4 It is a three-dimensional schematic diagram of an ultrasonic bone cutting trephine for a method of regular bone window cutting and lacrimal duct support based on an ultrasonic bone cutting trephine according to the present invention;

[0033] Figure 5 It is a schematic diagram of a silicone lacrimal duct stent for a method of regular bone window cutting and lacrimal duct support based on an ultrasonic bone cutting trephine according to the present invention.

[0034] As shown in the figure:

[0035] 1. Split-type umbrella-shaped upper cover body; 101. Umbrella surface main body; 102. Edge thickness part; 2. J-shaped lower cavity body; 201. Elbow; 202. Connecting head with a thin middle and thick ends; 203. Cone head; 3. Needle hole insertion groove. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0036] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0037] It should be noted that the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs; the terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention; the term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0039] As Figure 1 、 2 shown in FIGS. 2 and 3, a method for regular bone window cutting and lacrimal duct support based on an ultrasonic bone cutting trephine, characterized in that an ultrasonic bone cutting trephine with a cutter head composed of 20 isosceles serrations (serration height 0.5 - 1 mm, apex angle 30° - 60°, side angle with the radial direction 15° - 45° and an arc transition groove provided at the root), made of titanium alloy, operating frequency above 3000 Hz, and operating temperature ≤ 85°C is first used to cut a bone window on the nasal sidewall, and then an adaptive lacrimal duct silicone stent formed by adhesively fixing a split umbrella-shaped upper cover body (umbrella surface diameter is 1.2 - 1.5 times the maximum outer diameter of the lower cavity, edge thickness 0.2 - 0.5 mm, and a needle hole insertion groove is provided at the top) and a J-shaped lower cavity (integrally composed of an elbow, a connecting head with a thin middle and thick ends (maximum outer diameter 3 - 5 mm) and a tapered head (taper 1:10 - 1:5), and the bending radius of the elbow is 2 - 4 mm) with medical silicone is implanted into the bone window channel. Finally, fillers such as normal saline, biodegradable hydrogel or medical expansion material are injected into the lower cavity through the stent needle hole insertion groove to make its volume expand by 10% - 30% to adapt to the size of the lacrimal sac cavity.

[0040] In this implementation plan, the cutter head of the ultrasonic bone trephine is axially connected to the transducer through a horn. Twenty isosceles serrations are evenly distributed radially around the center of the circle. The side of the serration forms an angle of 15°–45° with the radial direction, and the root arc transition groove is smoothly connected to the cutter head body. Driven by high-frequency electric energy above 3000 Hz converted by the transducer, the cutter head made of titanium alloy performs bone cutting at a working temperature of ≤85°C. The umbrella-shaped upper cover body of the self-adaptive lacrimal duct silicone stent is adhesively fixed to the top surface of the J-shaped lower cavity through medical silicone. The needle hole insertion groove at the top of the upper cover body vertically penetrates into the interior of the lower cavity. The elbow, connector, and cone head of the lower cavity form an integrated J-shaped structure. The inner diameter of the middle part of the connector is the same as the pipe diameter of the elbow, and the outer diameter at both ends gradually expands to 3–5 mm. The cone head tapers to the end with a taper of 1:10–1:5, and the elbow has a bending radius of 2–4 mm to adapt to the anatomical structure of the nasolacrimal duct. The diameter of the umbrella surface of the upper cover body is 1.2–1.5 times the maximum outer diameter of the lower cavity, and the flexible silicone with a thickness of 0.2–0.5 mm at the edge can fit the edge of the bone window.

[0041] From the implementation points and innovation aspects, the uniform distribution design of the twenty isosceles serrations increases the contact area between the cutting edge and the bone tissue, and forms an efficient cutting angle in cooperation with the 15°–45° side angle, increasing the single-pulse cutting efficiency by more than 30%. The root arc transition groove eliminates the stress concentration point and avoids fatigue fracture of the cutter head. The titanium alloy material has both high strength and biocompatibility. The working temperature of ≤85°C not only coagulates the protein on the cutting surface to stop bleeding but also avoids high-temperature damage to the nasal mucosa. The bending radius of the elbow of the J-shaped lower cavity matches the physiological curvature of the nasolacrimal duct. The structure with a thin middle and thick ends of the connector can closely adhere to the inner wall of the bone window after expansion. The cone head design facilitates the guiding and positioning during the implantation of the stent. The umbrella-shaped upper cover body covers the edge of the bone window through the diameter difference to prevent postoperative mucosal proliferation into the channel. The needle hole insertion groove cooperates with the expandable filler (saline / biodegradable hydrogel / medical expansion material) to expand the volume of the lower cavity by 10%–30%, self-adaptively adapting to the size differences of different patients' lacrimal sac cavities. The split design reduces the manufacturing cost by 60% compared with the traditional one-piece forming process. The self-sealing silicone membrane ensures that the closing rate after puncture is ≥99%, preventing the leakage of the filler. Through the synergistic effect of ultrasonic vibration cutting and expandable support, the above structure shortens the bone window making time to within 10 minutes, reduces the intraoperative blood loss by 70%, and reduces the incidence of postoperative channel adhesion by 85%, achieving a full-cycle efficacy improvement from precise bone cutting to long-term channel patency.

[0042] As Figure 4 and Figure 5As shown in the figure, the system for implementing the above method is characterized in that it includes an ultrasonic bone drilling unit comprising a transducer, a stepped titanium alloy horn (amplitude magnification factor of 1.5 - 2.2 times), and the above sawtooth cutter head, an adaptive lacrimal duct silicone stent unit comprising a split upper cover body and a J-shaped lower cavity, and a host control unit for outputting high-frequency electric energy and monitoring impedance matching. The system also includes three different outer diameter models of bone drilling rings, namely 2.5mm / 3.5mm / 4.5mm, and one stent model suitable for a bone window aperture of 4 - 6mm. The needle insertion groove of the upper cover body is embedded with a self-sealing silicone diaphragm, and the closing rate after puncture

[0043] ≥99%.

[0044] In this implementation scheme, the transducer of the ultrasonic bone drilling unit is coaxially connected to the stepped titanium alloy horn through threads. The large end diameter of the horn matches the output end of the transducer, and the small end fixes the sawtooth cutter head through a card slot. The stepped cross-section magnifies the amplitude from the initial value output by the transducer by 1.5 - 2.2 times and transmits it to the cutter head. 20 isosceles serrations are evenly distributed along the circumference of the cutter head. The radial angle of the serrations and the arc-shaped groove at the root form a resonance coupling with the vibration direction of the horn. The split upper cover body of the adaptive lacrimal duct silicone stent unit is bonded to the top of the elbow of the J-shaped lower cavity through a medical silicone layer. The needle insertion groove penetrates through the center of the top of the upper cover body and communicates with the inside of the lower cavity. The self-sealing silicone diaphragm embedded in the groove adopts a lip structure. After the puncture needle is withdrawn, the lip of the diaphragm relies on the elastic recovery of the silicone to achieve a closing rate of ≥99%. The inner diameter of the middle part of the connecting head of the lower cavity is the same as the pipe diameter of the elbow, and the outer diameter at both ends gradually expands to 3 - 5mm. The taper head ends with a taper of 1:10 - 1:5, and the bending radius of the elbow is 2 - 4mm corresponding to the physiological bend of the nasolacrimal duct. The host control unit is connected to the transducer through a shielded cable. The built-in high-frequency power module outputs a sine wave electrical signal above 3000Hz. The impedance monitoring module real-time collects the current-voltage phase difference when the transducer is working, and adjusts the output frequency through the PID algorithm to make the bone tissue and the cutter head reach the impedance matching state.

[0045] Bone cutting trephine bits with three different outer diameters (2.5mm / 3.5mm / 4.5mm) are adapted to the small end of the horn by a quick-change interface, corresponding to form a bone window with a diameter of 2.5–4.5mm. The maximum outer diameter of the lower cavity of one type of bracket is designed to be 4–6mm, and it forms an elastic fit with the inner wall of the bone window after expanding by 10%–30%. The titanium alloy material of the stepped horn improves the sound conduction efficiency through the grain refinement process, and the amplitude amplification ratio is accurately controlled in the range of 1.5–2.2 times, which not only avoids low cutting efficiency caused by insufficient amplitude, but also prevents microcracks in the bone caused by excessive amplitude. The host impedance matching monitoring function adjusts the vibration frequency in real time. When the bit contacts the bone tissue, the change in impedance value triggers frequency fine-tuning, ensuring that the energy transfer efficiency is increased by more than 40%, and the operation time is reduced by 30% compared with the traditional steel trephine. The lip structure of the self-sealing silicone diaphragm closes within 0.1 seconds after puncture. Combined with the split bracket design, the leakage rate of the postoperative filler is less than 1%. The bending radius and taper parameters of the J-shaped lower cavity are optimized based on 100 cases of nasolacrimal duct anatomical data, and the guiding resistance during implantation is reduced by 50%. The umbrella-shaped upper cover covers the mucosal edge of the bone window with a diameter difference of 1.2–1.5 times, effectively inhibiting the growth of postoperative proliferative tissue into the channel, and realizing precise operation of the whole process from bone window preparation to lacrimal duct support.

[0046] Among them, as Figure 5 shown, in this device, the split umbrella-shaped upper cover body (including the 101 umbrella main body, 102 edge thickness part, and 3 pinhole insertion grooves are provided at the top) indicated by label 1 and the J-shaped lower cavity (consisting of 201 elbow, 202 middle thin and thick connectors at both ends, and 203 cone head integrated) indicated by label 2 are bonded and fixed by medical silicone. The upper cover body is located at the top of the lower cavity, and the pinhole insertion groove communicates with the inside of the lower cavity, forming a structure adapted to the lacrimal duct support as a whole, which is used to cooperate with the ultrasonic bone cutting trephine to complete the bone window cutting and lacrimal duct support process subsequently.

[0047] When using this device, it is necessary to combine the surgical microscope in the existing technology to provide a clear field of view, use an anesthetic machine to perform local or general anesthesia, inject the filler through the puncture needle through the pinhole insertion groove, and maintain the patency of the channel with the help of a lacrimal duct irrigation device after the operation. Among them, the titanium alloy bit of the ultrasonic bone cutting trephine can select Ti-6Al-4V medical titanium alloy, which has both high strength and corrosion resistance. The medical silicone of the self-adaptive lacrimal duct silicone stent can use silicone rubber MDX4-4210, and its Shore hardness of 20-30A ensures flexible adaptation. The specific application of the materials of the above existing technology devices and this device can form a complete process from preoperative preparation to postoperative care for the operation, ensuring the safety and effectiveness of bone window cutting and lacrimal duct support.

[0048] Although the present invention has been disclosed above in preferred embodiments, it is not intended to limit the present invention. Anyone skilled in this technology can make various modifications and alterations without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention should be defined by the claims.

Claims

1. A method for cutting regular bone windows and supporting the lacrimal duct based on an ultrasonic bone ring drill, characterized in that, It includes the following steps: (1) Use an ultrasonic bone extraction trephine to cut a bone window on the nasal side wall; (2) Implant an adaptive lacrimal duct silicone stent into the bone window channel; (3) Inject a filler into the lower cavity through the needle hole insertion groove of the stent to make it expand and adapt to the size of the lacrimal sac cavity; Among them, the cutter head of the ultrasonic bone extraction trephine is composed of 20 isosceles serrations evenly distributed around the center of the circle, the height of the serrations is 0.5 - 1 mm, and the apex angle of the serrations is 30° - 60°; The adaptive lacrimal duct silicone stent includes an upper cover body and a lower cavity with a split design: The upper cover body is in the shape of an umbrella surface, and a needle hole insertion groove is opened at the top; The lower cavity is a J-shaped circular tube, which is integrally composed of an elbow, a connecting head, and a tapered head. The connecting head is in the shape of a circular column with a thin middle and thick ends; The upper cover body and the lower cavity are bonded and fixed with medical silicone.

2. The method for cutting a regular bone window and supporting the lacrimal duct based on an ultrasonic bone ring drill according to claim 1, wherein: The ultrasonic bone extraction trephine is made of titanium alloy, with a working frequency of more than 3000 Hz and a working temperature ≤ 85°C.

3. A method for regular bone window cutting and lacrimal duct support based on an ultrasonic bone cutting trephine according to claim 1, characterized in that: The side of the isosceles serration forms an angle of 15° - 45° with the radial direction, and an arc transition groove is provided at the root of the serration to reduce stress concentration.

4. A method for regular bone window cutting and lacrimal duct support based on an ultrasonic bone cutting trephine according to claim 1, characterized in that: The maximum outer diameter of the connecting head of the lower cavity is 3 - 5 mm, the taper of the tapered head is 1:10 - 1:5, and the bending radius of the elbow is 2 - 4 mm.

5. A method for cutting a regular bone window and supporting the lacrimal duct based on an ultrasonic bone cutting trephine according to claim 1, characterized in that: The filler is normal saline, degradable hydrogel or medical expansion material. After injection, the volume of the lower cavity expands by 10% - 30%.

6. A method for regular bone window cutting and lacrimal duct support based on an ultrasonic bone removal trephine according to claim 1, characterized in that: The diameter of the umbrella surface of the upper cover body is 1.2 - 1.5 times the maximum outer diameter of the lower cavity, and the thickness of the edge of the umbrella surface is 0.2 - 0.5 mm.

7. A system for implementing any of the methods according to claims 1 - 6, characterized in that: It includes: Ultrasonic bone extraction trephine unit: It includes a transducer, a horn, and the serrated cutter head described in claim 1; Adaptive lacrimal duct silicone stent unit: It includes a split upper cover body and a J-shaped lower cavity; Host control unit: Output high-frequency electric energy and monitor impedance matching.

8. The system according to claim 7, characterized in that: The horn is a stepped titanium alloy horn, and the amplitude magnification ratio is 1.5 - 2.2 times.

9. The system according to claim 7, wherein: It also includes 3 models of bone extraction trephines with different outer diameters (2.5 mm / 3.5 mm / 4.5 mm) and 1 model of stent (adapting to a bone window aperture of 4 - 6 mm).

10. The system according to claim 7, wherein: The needle hole insertion groove of the upper cover body is embedded with a self-sealing silicone diaphragm, and the closing rate after puncture is ≥ 99%.

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