Self-anchored lacrimal passage drainage device for repairing fracture of lacrimal ductule

Abstract

The invention provides a self-anchored lacrimal passage drainage device for lacrimal ductule fracture repair, which comprises a skeleton probe, the skeleton probe comprises a nickel-titanium alloy skeleton, and one end of the nickel-titanium alloy skeleton is located in an inner hole of a lacrimal passage drainage tube main body; a lacrimal point fornix part is arranged at one end of the lacrimal passage drainage tube body, a handle and a lacrimal point expansion conical head are sequentially arranged at the end, away from the lacrimal point fornix part, of the nickel-titanium alloy framework, one end of a short tube is arranged on the lacrimal passage drainage tube body, the short tube is close to the lacrimal point fornix part, and a right angle is formed between the short tube and the axis of the lacrimal passage drainage tube body. The other end of the short tube is provided with an anchoring end, the anchoring end is of an umbrella-shaped valve structure, the center of the anchoring end is provided with a lacrimal point administration hole, and the lacrimal point administration hole is communicated with an inner hole of the lacrimal passage drainage tube body through the short tube. The three-dimensional mechanical lock catch type anchor section at the head end of the silica gel drainage tube is adopted, and single-step permanent fixation is achieved at the punctum fornix part; a nickel-titanium skeleton-lacrimal passage drainage tube body preassembled design is adopted, and one-time precise implantation is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a self-anchoring lacrimal duct drainage device for repairing lacrimal duct rupture. Background Art

[0002] Lacrimal duct rupture is a very common complication of eyelid trauma, with a reported incidence of 16%-25% of eyelid injuries. Injury to the inferior canaliculus predominates, accounting for approximately 72% of cases, highlighting the importance of repair techniques targeting the inferior canaliculus. Currently, commonly used repair methods face significant challenges. When using silicone tube fixation (such as the Crawford tube), the suture ligation can easily irritate local tissues, inducing granulomatous proliferation, which occurs in approximately 18% of cases. This not only affects aesthetics but can also obstruct the tear duct. While delicate microsurgery techniques strive for precise docking, the risk of postoperative re-rupture is a concern, with literature reporting rates as high as 30%, leading to surgical failure. While memory alloy stents have their advantages, the risk of local mucosal ischemia following implantation is also prominent, occurring in approximately 21% of cases, limiting their widespread use.

[0003] An in-depth analysis of existing tear duct drainage tube implantation technology reveals the following technical defects: 1) The drainage tube has a high anchoring failure rate, weak anchoring, and poor stability: The anchoring mechanism of existing drainage tubes designed in the lacrimal punctum and lacrimal canaliculus is often weak or unreliable. After surgery, the drainage tube is very likely to shift or even completely dislocate, which is a common cause of surgical failure and recurrent tear duct obstruction. Patients are often forced to undergo painful secondary surgery for repositioning or replacement; 2) The implantation operation is complex and difficult, and retrograde implantation is very traumatic and has a high risk of trauma: The standard implantation process usually requires the surgeon to first use a hard metal probe to forcibly explore the tear duct to create a channel, and then use a "retrograde" method (i.e., from the nasal cavity to the lacrimal punctum) to painstakingly introduce the drainage tube into the tear duct. This process can easily scratch or even tear the fragile nasal mucosa, causing bleeding, increasing the patient's pain and risk of infection. What is even more difficult is that the operating space is narrow and the vision is limited, and the implantation often requires the assistance of a nasal endoscope. The false passage formation rate is >8%, which significantly increases the technical difficulty, time and equipment cost of the operation; 3) The connection between the probe and the tube body is fragile, and the risk of a false passage is significant: During the critical implant advancement process, there is a lack of effective mechanical locking or stable connection mechanism between the metal probe and the silicone drainage tube body. If there is a slight mistake or resistance during the operation, the probe can easily slip off the tube body. Once slipped, the sharp metal probe can easily deviate from the normal anatomical path of the lacrimal duct and forcibly penetrate the surrounding soft tissue to form a "false passage." The incidence of false passage formation is about 8-12%, which not only causes additional tissue damage, bleeding and inflammation, seriously interferes with the surgical process, but is also an important cause of poor drainage, infection and even surgical failure after surgery.

[0004] Therefore, how to design a self-anchoring lacrimal passage drainage device for lacrimal canaliculus fracture repair becomes a problem to be solved. SUMMARY

[0005] In view of the problems in the prior art, the self-anchoring lacrimal passage drainage device for lacrimal canaliculus fracture repair is provided to solve at least one of the above technical problems.

[0006] The technical scheme of the present application is: a self-anchoring lacrimal passage drainage device for lacrimal canaliculus fracture repair, comprising a framework probe, the framework probe comprising a nickel-titanium alloy framework, one end of the nickel-titanium alloy framework being located in the inner hole of a lacrimal passage drainage tube main body; one end of the lacrimal passage drainage tube main body is provided with a punctum dome portion, the nickel-titanium alloy framework is sequentially provided with a handle and a punctum expansion cone head away from the one end of the punctum dome portion, one end of the lacrimal passage drainage tube main body is provided with a short tube, the short tube is close to the punctum dome portion, the short tube is at a right angle to the axis of the lacrimal passage drainage tube main body, the other end of the short tube is provided with an anchoring end, the anchoring end is an umbrella-shaped valve structure, the center of the anchoring end is provided with a punctum drug delivery hole, the punctum drug delivery hole is communicated with the inner hole of the short tube and the lacrimal passage drainage tube main body.

[0007] The present application adopts a silicone lacrimal passage drainage tube containing a punctum fixed anchor section, an anchoring end with an umbrella-shaped valve structure is integrated at the punctum end of the drainage tube, the umbrella-shaped valve structure forms a three-point mechanical lock with the punctum dome portion after expansion, the shape and size of the anchor section are precisely optimized to firmly “snap” or “anchor” the punctum dome portion and the adjacent lacrimal canaliculus wall, providing reliable mechanical fixation, solving the problem of postoperative displacement and shedding of the drainage tube from the source; the nickel-titanium alloy framework probe is pre-installed, abandoning the traditional separate hard metal probe, the nickel-titanium alloy probe framework with super-elasticity, shape memory and excellent biocompatibility is functionally integrated with the silicone drainage tube body, the flexibility of the nickel-titanium alloy enables it to conform to the natural curvature of the lacrimal passage, significantly reducing the risk of tissue damage caused by forced exploration, effectively preventing probe slippage, and greatly reducing the probability of the formation of false passages (8-12%) during surgery; the “anchoring-implantation” integrated solution solves the two technical defects of high drainage tube anchoring failure rate (leading to secondary surgery) and large trauma of retrograde implantation (requiring endoscopic assistance, false passage formation rate > 8%) in lacrimal canaliculus fracture repair. BRIEF DESCRIPTION OF DRAWINGS

[0008] Figure 1 It is an installation structure diagram of the present application.

[0009] Figure 2 It is a drainage tube structure diagram of the present application.

[0010] Figure 3 It is an implantation diagram of the present application.

[0011] In the figure: 1. Punctal dilator; 2. Handle; 3. Nitinol skeleton; 4. Anchoring end; 5. Punctal drug delivery hole; 6. Lacrimal drainage tube body; 601. Micropore; 602. Punctal fornix. DETAILED DESCRIPTION

[0012] The present invention will be further described below with reference to the accompanying drawings.

[0013] See Figure 1-3 The structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read. They are not used to limit the conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change in the proportional relationship or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the efficacy and purpose that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0014] Example 1: A self-anchoring lacrimal drainage device for repairing lacrimal duct rupture, referring to Figure 1 、 Figure 2, including a skeleton probe, which includes a nickel-titanium alloy skeleton 3, one end of the nickel-titanium alloy skeleton 3 is located in the inner hole of the lacrimal drainage tube body 6; one end of the lacrimal drainage tube body 6 is provided with a lacrimal dome 602, and the nickel-titanium alloy skeleton 3 is provided with a handle 2 and a lacrimal expansion cone head 1 in sequence toward the end away from the lacrimal dome 602, and the lacrimal drainage tube body 6 is provided with one end of a short tube, the short tube is close to the lacrimal dome 602, and the short tube is at right angles to the axis of the lacrimal drainage tube body 6, and the other end of the short tube is provided with an anchoring end 4, the anchoring end 4 is an umbrella-shaped valve structure, and the center of the anchoring end 4 is provided with a lacrimal drug delivery hole 5, and the lacrimal drug delivery hole 5 is communicated with the inner hole of the lacrimal drainage tube body 6 through the short tube. The present invention adopts a silicone lacrimal drainage tube with a tear point fixed anchor section. The anchor end of the umbrella-shaped valve structure is integrated at the tear point end of the drainage tube. After the umbrella-shaped valve structure expands, it forms a three-point mechanical lock with the tear point dome. The shape and size of the anchor section have been precisely optimized to firmly "snap" or "anchor" to the tear point dome and the adjacent lacrimal canaliculus wall, providing reliable mechanical fixation and solving the problem of postoperative displacement and prolapse of the drainage tube from the source; the nickel-titanium alloy skeleton probe pre-installed design abandons the traditional separate hard metal probe, and combines the super elasticity, shape memory and excellent The biocompatible nickel-titanium alloy probe skeleton and the silicone drainage tube body are functionally integrated. The flexibility of nickel-titanium alloy enables it to conform to the natural curvature of the tear duct, significantly reducing the risk of tissue damage caused by forced probing, effectively avoiding probe slippage, and greatly reducing the probability of serious complications such as the formation of false passages during surgery (8-12%). The "anchoring-implantation" integrated solution solves the two major technical defects of high drainage tube anchoring failure rate (leading to secondary surgery) and large trauma of retrograde implantation (requiring nasal endoscopy assistance and false passage formation rate >8%) during lacrimal duct rupture repair surgery.

[0015] Example 2: Based on Example 1, several micropores 601 are provided between the other end of the lacrimal drainage tube body 6 and the short tube. The spacing between adjacent micropores 601 near the other end of the lacrimal drainage tube body 6 is 200 μm, and the spacing between adjacent micropores 601 near one end of the short tube is 500 μm. The micropores 601 at both ends are arranged in a gradient. The present invention adopts a gradient arrangement of micropores at both ends. The gradient therapeutic micropores in the tube body can be used for lacrimal duct drug delivery. The gradient micropores achieve segmented drug release, reducing the anastomotic stenosis rate from 40% to 8.3%.

[0016] Example 3: Based on Example 2, the thickness of the umbrella-shaped valve structure is 0.1 mm, and the expansion angle of the umbrella-shaped valve structure is 120°. The present invention uses an umbrella-shaped valve structure with a thickness of 0.1 mm. The umbrella-shaped valve structure has an expansion angle of 120° after expansion, forming a three-point mechanical lock with the lacrimal dome to achieve zero-dislodgement anchoring.

[0017] Example four, on the basis of example two, the nickel-titanium alloy framework 3 uses the nickel-titanium wire with the diameter of 0.3-0.5 mm, and the preset curvature radius is 4 mm.The super-elastic nickel-titanium alloy wire with the diameter of 0.3-0.5 mm is used in the application, has the shape memory characteristic, the preset curvature radius is 4 mm, and can match the physiological bending of the lacrimal canaliculus.

[0018] Example five, on the basis of example four, the other end of the nickel-titanium alloy framework 3 uses the laser cutting to form the punctum dilatation cone head 1 and the handle 2.The laser cutting nickel-titanium framework is used in the application to complete the processing of the punctum dilatation cone head and the handle.

[0019] Example six, on the basis of example four, the taper angle of the punctum dilatation cone head 1 is 25°±5°, and the length is 2.5 mm.The distal end integrated punctum dilatation cone head is used in the application, the taper angle is 25°±5°, the length is 2.5 mm, and is used for minimally invasive expansion of the punctum.

[0020] Example seven, on the basis of example one, the lacrimal passage drainage tube body 6 and the short pipe all use the liquid silicone rubber injection mold, the nickel-titanium alloy framework 3 is pre-buried in the pipe wall, and after solidification, an integrated structure is formed.The pipe wall pre-buried nickel-titanium framework is used in the application to form an integrated structure, which can maintain the rigidity of the drainage tube during the operation.

[0021] Example eight, on the basis of example seven, the one end of the nickel-titanium alloy framework 3 close to the punctum dome part 602 is further provided with a screw type handle, the root part of the handle is processed with an annular fracture groove, and the depth of the annular fracture groove is 1 / 3 of the diameter of the nickel-titanium alloy framework 3.The proximal end of the application is provided with a screw type handle, the root part of the handle is processed with an annular fracture groove, the depth of the annular fracture groove is 1 / 3 of the diameter of the probe, and the safe separation after implantation is realized;the fracture groove design makes the framework separation only needs a single rotation (20°±5°), and there is no risk of metal residue.

[0022] Example nine, the instrument preparation process of the application is as follows:

[0023] ①The nickel-titanium wire with the diameter of 0.4 mm is used, and the laser cutting is used to form the cone head and the memory bending section;

[0024] ②The handle is injection molded with medical-grade polycarbonate, the annular fracture groove has the depth of 0.13 mm, and the nickel-titanium alloy framework 3 has the diameter of 1 / 3 of the diameter of the nickel-titanium alloy framework 3;

[0025] 2), drainage tube forming:

[0026] ①The liquid silicone rubber is injected into the mold, the nickel-titanium alloy framework 3 is pre-buried in the pipe wall, and after solidification, an integrated structure is formed;

[0027] ②The anchoring section 4 uses the laser engraving umbrella-shaped valve structure (the flap thickness is 0.1 mm, and the expansion state opening angle is 120°);

[0028] ③ Microholes were processed by micro-drilling, with a proximal hole distance of 200 μm and a distal hole distance of 500 μm.

[0029] The invention provides an innovation in lacrimal punctum anchoring - a three-dimensional mechanical locking anchor segment at the tip of the silicone drainage tube is used to achieve single-step permanent fixation at the lacrimal punctum fornix, completely eliminating the risk of postoperative dislocation and avoiding secondary surgery; the invention also provides a revolution in antegrade implantation - a pre-assembled nickel-titanium skeleton-lacrimal drainage tube design is used to achieve one-time precise implantation, shortening the operation time and eliminating the reliance on nasal endoscopy.

[0030] In practice, the present invention uses an antegrade implantation method, where the surgeon directly inserts the drainage tube (guided by a nickel-titanium skeleton) through the lacrimal punctum, "anterogradely" along the physiological direction of the lacrimal canaliculus, into the nasal cavity (i.e., from the lacrimal punctum toward the nasal cavity). This implantation follows the tear flow path (punctum → lacrimal sac → nasal cavity), avoiding retrograde nasal manipulation and achieving a non-invasive implantation method that conforms to the anatomical flow direction. The antegrade implantation path shortens the surgical time to 5±1.2 minutes (compared to ≥15 minutes for traditional procedures), making the operation more intuitive and ergonomic, and avoiding complex retrograde manipulation and excessive intrusion into the nasal cavity.

[0031] The surgical operation process of the present invention:

[0032] 1) Anesthesia: local infiltration anesthesia at the affected tear point;

[0033] 2) Implantation: Insert the lacrimal punctum dilator 1 through the lacrimal punctum and follow the antegrade implantation path (lacrimal punctum → lacrimal canaliculus → nasal cavity) and advance it into the nasal cavity (see Figure 3 Stop when the handle scale indicates the entry depth is ≥30mm;

[0034] 3) Anchoring: Fix the drainage tube and rotate the handle 20° in the opposite direction to the fracture groove (see Figure 3 As shown, the anchor segment is located in the lacrimal fornix);

[0035] 4) Separation: Slowly withdraw the nickel-titanium alloy skeleton 3, and the anchoring structure will automatically expand in the lacrimal fornix; confirm the valve fit under a microscope (gap < 0.1 mm);

[0036] 5) Verification: Gently pull the drainage tube to confirm that it is firmly anchored (displacement < 0.5 mm);

[0037] 6) Medication: Connect the injection port to a syringe and inject 0.5 ml of antibiotic eye drops.

[0038] Postoperative management process of the present invention:

[0039] 1) Anchoring and maintenance: The expanded valve forms a mechanical and biological dual fixation with the lacrimal canaliculus wall;

[0040] 2) Administration: Microporous antibiotic eye drops once a week via the eye port (week 1)

[0041] 3) Removal: After 3 months, the valve is directly removed through the tear point. The expanded valve collapses due to traction without tissue damage.

[0042] Key points of postoperative management: Targeted injection of anti-scar drugs through the injection port in the first week to avoid pulling the drainage tube (displacement threshold <1mm). If resistance increases, pulsed warm saline flushing is required to maintain micropore patency.

[0043] The present invention designs a silicone tear duct drainage tube with an anchor segment for tear punctum fixation, and combines it with a pre-installed nickel-titanium skeleton probe design to assist in the antegrade implantation of the tear duct drainage tube. The core advantages are: 1. Significantly reduce the risk of false passage formation: The pre-installed nickel-titanium skeleton provides stable guidance, effectively prevents the probe from slipping, and greatly reduces the probability of a serious complication, false passage formation (8-12%), during surgery; 2. Significantly shorten the operation time and improve efficiency: The antegrade implantation mode simplifies the operating steps, reduces the dependence on the nasal endoscope, makes the drainage tube implantation process faster and smoother, and significantly shortens the overall operation time; 3. Enhance anchoring reliability and reduce secondary surgery: The unique tear punctum anchoring design ensures the long-term stability of the drainage tube, minimizes the postoperative dislocation rate, and thus reduces the pain and burden of patients undergoing secondary surgery due to dislocation; 4. Reduce intraoperative tissue damage: The flexibility of nickel-titanium alloy and the antegrade implantation method reduce mechanical damage to the nasal mucosa, reducing the incidence and severity of intraoperative nosebleeds.

[0044] The above embodiments of the present invention are merely preferred embodiments of the present invention. It should be noted that a person skilled in the art may make several improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A self-anchoring lacrimal drainage device for repairing a broken lacrimal canaliculus, comprising a skeleton probe, characterized in that: The skeleton probe comprises a nickel-titanium alloy skeleton (3), one end of which is located in the inner hole of the lacrimal drainage tube body (6); a lacrimal dome portion (602) is provided at one end of the lacrimal drainage tube body (6); a handle (2) and a lacrimal expansion cone head (1) are sequentially provided on the nickel-titanium alloy skeleton (3) toward the end away from the lacrimal dome portion (602); one end of a short tube is provided on the lacrimal drainage tube body (6), the short tube is close to the lacrimal dome portion (602), and the short tube is at right angles to the axis of the lacrimal drainage tube body (6); the other end of the short tube is provided with an anchoring end (4), the anchoring end (4) is an umbrella-shaped valve structure, and a lacrimal drug administration hole (5) is provided at the center of the anchoring end (4), and the lacrimal drug administration hole (5) is communicated with the inner hole of the lacrimal drainage tube body (6) through the short tube.

2. The self-anchoring lacrimal drainage device for repairing lacrimal duct rupture according to claim 1, characterized in that: Several micropores (601) are provided between the other end of the lacrimal drainage tube body (6) and the short tube. The pore spacing between adjacent micropores (601) near the other end of the lacrimal drainage tube body (6) is 200 μm, and the pore spacing between adjacent micropores (601) near one end of the short tube is 500 μm. The micropores (601) at both ends are arranged in a gradient.

3. The self-anchoring lacrimal drainage device for repairing lacrimal duct rupture according to claim 2, characterized in that: The thickness of the umbrella-shaped valve structure is 0.1 mm, and the expansion angle of the umbrella-shaped valve structure is 120°.

4. The self-anchoring lacrimal drainage device for repairing lacrimal duct rupture according to claim 2, characterized in that: The nickel-titanium alloy skeleton (3) uses nickel-titanium wire with a diameter of 0.3-0.5 mm, and a preset curvature radius of 4 mm.

5. The self-anchoring lacrimal drainage device for repairing lacrimal duct rupture according to claim 4, characterized in that: The other end of the nickel-titanium alloy skeleton (3) is cut by laser to form a lacrimal point expansion cone (1) and a handle (2).

6. The self-anchoring lacrimal drainage device for repairing lacrimal duct rupture according to claim 4, characterized in that: The lacrimal point expansion cone head (1) has a cone angle of 25°±5° and a length of 2.5 mm.

7. The self-anchoring lacrimal drainage device for repairing lacrimal duct rupture according to claim 1, characterized in that: The lacrimal drainage tube main body (6) and the short tube are both made of liquid silicone injected into a mold, and the nickel-titanium alloy skeleton (3) is pre-buried in the tube wall, and an integrated structure is formed after solidification.

8. The self-anchoring lacrimal drainage device for repairing lacrimal duct rupture according to claim 7, characterized in that: The nickel-titanium alloy skeleton (3) is also provided with a screw-type handle at one end close to the lacrimal punctum fornix (602), and a circular fracture groove is machined at the root of the handle.

9. The self-anchoring lacrimal drainage device for repairing lacrimal duct rupture according to claim 8, characterized in that: The depth of the annular fracture groove is 1 / 3 of the diameter of the nickel-titanium alloy skeleton (3).

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