CN110711075A

CN110711075A - Lacrimal duct embolism

Info

Publication number: CN110711075A
Application number: CN201810808607.0A
Authority: CN
Inventors: 吴坚; 周永华; 李刚
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-07-11
Filing date: 2018-07-11
Publication date: 2020-01-21
Also published as: WO2020011215A1

Abstract

The invention discloses a lacrimal duct embolism, which comprises: a body extending in an axial direction of the lacrimal canaliculus; the outer side wall of the body is provided with a convex part extending towards the wall direction of the lacrimal canaliculus, and the surface of the convex part, at least one part of the outer wall of the body and the wall of the lacrimal canaliculus form a lacrimal passage. The lacrimal passage is changed from a traditional inner wall passage to an outer wall passage, and the convex part not only serves as a structure for forming the lacrimal passage, but also serves as a structure for clamping the lacrimal duct plug in the lacrimal duct to fix the lacrimal duct plug. The lacrimal duct embolism is prepared by adopting a process method of using an SIBS elastomer material with excellent biocompatibility and biological stability to prepare alone or melt blending with nano silver particles. The new generation lacrimal duct embolism product prepared by the invention has simple structure, reliable and stable positioning, greatly reduces the occurrence probability of foreign body reaction and tissue inflammation, has wide market prospect, quite strong market competitiveness and good social benefit.

Description

Lacrimal duct embolism

Technical Field

The invention relates to the field of medical instruments, in particular to a lacrimal duct embolism.

Background

Dry eye, also known as dry eye, keratoconjunctival dryness (KCS) is a common disease in which symptoms of keratoconjunctival dryness are predominant due to lacrimal dysfunction caused by systemic or local causes. The worldwide incidence of the diseases is high, and the causes of the diseases are not completely clear. But any disorder that results in dysbalance of tear production and drainage and dysfunction of the tear film can cause dry eye. The most common forms of systemic xerophthalmia, refractive corneal surgery, anterior segment burns, computer radiation, and the like. With the advent of the information age and the popularization of the mobile internet, people have been in contact with computers and mobile phones for a longer time, and the xerophthalmia also tends to increase year by year and become younger.

Dry eye disease is the common disease and frequently encountered disease in the clinical ophthalmology at present. Especially, the patients with long-term dry eye often have the symptoms of dryness, red eyes, itching, burning, foreign body sensation, stabbing pain, lacrimation, photophobia, visual deterioration, eye fatigue and the like, and great pain is brought to the patients. Severe dry eye will lead to a range of ocular surface diseases such as: corneal epithelial defects, degeneration of conjunctival or corneal epithelium, sterile corneal ulcer, infectious corneal ulcer, etc.

The current treatment of patients with mild dry eye syndrome is mainly conservative treatment, and the conservative treatment comprises methods of tear substitute, tear secretion promotion, tear preservation and the like, such as: 1) the artificial tears can moisten, lubricate and nourish the cornea to play a role similar to natural tears; 2) drugs (cyclosporine A, glucocorticoid, androgenic steroid, bromobenzylcyclohexylamine, and the like) are used for regulating immune function and promoting the secretion of lacrimal gland tissues and salivary gland tissues.

However, for patients with moderate and severe dry eye, the symptoms are still not relieved after long-term use of artificial tears, and a method of lacrimal duct obstruction is adopted: the small solid or tubular plug is put into lacrimal canaliculus to stop the tear flow to nasolacrimal duct, so that the residence time of limited tear in conjunctival sac is prolonged, on one hand, the storage of the tear of eyes is increased, natural tear is enabled to moisten cornea and conjunctival surface to improve the corneal surface, and a lasting moistening and protecting effect is provided, on the other hand, the tear is rich in immunoglobulin and ion components, electrolyte balance is maintained, and the defense capacity of the ocular surface is increased. Simultaneously reacts on lacrimal gland and conjunctiva goblet cells, promotes tear secretion, increases goblet cell survival, increases the stability of tear film, and simultaneously improves the capability of resisting external microorganisms on the surface of the eye. The eye dryness symptom of a patient is relieved and relieved through treatment, the surface of the cornea is smooth, and the function of the tear film is recovered to promote the restoration of the corneal epithelium. The method is easy, convenient and flexible to operate, and is more and more generally applied to clinical treatment of patients with moderate and severe xerophthalmia.

The clinical lacrimal duct embolism is generally divided into degradation type and permanent type (non-degradation type), and the permanent type lacrimal duct embolism is mainly adopted for patients with moderate and severe dry eye.

At present, the permanent lacrimal duct embolism mostly adopts silica gel material. The silica gel material has good biocompatibility and biological stability, good mechanical elasticity and easy processing. However, Silica (Silica), oligomers (oligomers), and cyclic monomers (cyclic monomers) are present in the preparation of Silica gel materials, and the long-term presence of these impurities can cause ocular foreign body reactions (shroud body reactions).

In recent years, other new materials are gradually searched and adopted in the preparation of the permanent lacrimal canaliculus plug, and the trend of replacing the traditional organosilicon materials is high. Wherein, the American Medenium company adopts polyacrylate copolymer with heat memory function, invents intelligent permanent lacrimal duct embolism Smartplug^@And the United states of America

Company adopts non-degradable hydrogel to invent Form Fit Plug for lacrimal duct embolism^@. The two lacrimal duct plugs are closed type lacrimal duct plugs. However, complete occlusion of the lacrimal passage will result in the inability of tears to infiltrate and irrigate the lacrimal canaliculus, lacrimal sac, and nasolacrimal passage below the embolism. Because the antibacterial component in the tears can not reach the parts, the occurrence rate of inflammation of lacrimal sac and lacrimal nasal meatus is greatly increased, and the long-term retention of the metabolized lacrimal water in the lacrimal canaliculus on the upper part of the embolism can cause the mass propagation of microorganisms in the lacrimal canaliculus and cause the canaliculitis.

Disclosure of Invention

The invention aims to provide a lacrimal duct embolism, which can control the discharge speed of tears relatively and avoid the slippage of the embolism so as to meet the requirements of patients with different dry eye symptom degrees.

The technical scheme provided by the invention is as follows:

a lacrimal canaliculus plug, comprising:

a body extending in an axial direction of a lacrimal canaliculus;

the outer side wall of the body is provided with a convex part extending towards the wall direction of the lacrimal canaliculus, and the surface of the convex part and at least a part of the outer wall of the body form a lacrimal passage.

In the technical scheme, the lacrimal passage is creatively changed from the inner wall passage in the common knowledge to the outer wall passage, and the bulge part is used as a structure for forming the lacrimal passage and also used as a structure for clamping the lacrimal duct plug in the lacrimal duct to fix the lacrimal duct plug. Because of considering the comfort of human body, the material for manufacturing the lacrimal canaliculus is made of polyisobutylene elastomer material with excellent biocompatibility and biological stability. Compared with the lacrimal passage in the body, the lacrimal passage avoids the passage blockage caused by the deformation of the lacrimal canaliculus on the outer side of the body, so that the lacrimal fluid flows out more smoothly. Moreover, compare traditional cavity tubulose and solid columnar lacrimal canaliculus embolism, the lacrimal canaliculus embolism among this technical scheme is only contacted with the lacrimal canaliculus wall by the outer fringe of bulge to adopt the polyisobutene elastomer material that the comfort level is higher, the reduction patient foreign body sensation and anaphylactic reaction as far as possible have improved use experience.

Preferably, the projection is left-hand or right-hand threads around the body, and the tear channel is formed by a left-hand or right-hand threaded surface and a portion of the body outer wall.

In the technical scheme, the tear channel is formed by left-handed threads or right-handed threads surrounding the body, the surface of the threads and a part of the outer wall of the body form the wall of the tear channel together, the outer edge of the threads is supported on the wall of the lacrimal canaliculus, the support property is good, the thread processing is also very convenient, and the requirements of different degrees of lacrimal canaliculus embolism are met.

Further preferably, the tear flow rate is adjustable by changing the pitch of the left-hand or right-hand threads of the body.

In the technical scheme, the outflow rate of tears is adjusted by adjusting the thread pitch of the threads (under the condition that the inner diameter and the outer diameter of the threads are fixed, the adjustment of the thread pitch is also equivalent to the adjustment of the spiral angle), so that the requirements of patients with different xerophthalmia symptom degrees are met.

Unlike the threading solution, the invention also provides another preferred solution,

the protruding part is a boss, the boss protrudes from the body along the radial direction of the body, and at least one boss is arranged;

the peripheral wall of each boss is provided with a groove, and the groove wall and at least one part of the outer wall of the body form the tear channel. In the technical scheme, the outflow rate of tears can be adjusted by changing the number of the bosses, the opening angle of the groove, the opening depth of the groove and the number of the grooves, so that the requirements of different lacrimal duct embolism degrees are met.

Further preferably, the boss is one, or two or more axially spaced apart.

In the technical scheme, the stability of the lacrimal duct embolism placed in the lacrimal duct can be adjusted by changing the number of the bosses, and two or more of the bosses are more stable.

Further preferably, each of the bosses has at least one of the grooves, or two or more grooves.

In the technical scheme, the outflow rate of tears is adjusted by adjusting the number of the grooves so as to meet the requirements of different lacrimal duct embolism degrees.

Further preferably, when the number of the grooves is two or more, the grooves are uniformly distributed along the circumferential direction of the body.

In the technical scheme, the circumferential uniform distribution of the grooves is convenient to process.

Further preferably, when the number of the bosses is more than two, the grooves of two adjacent bosses are oppositely arranged or staggered.

In the technical scheme, the grooves are oppositely arranged or staggered so as to adjust the flow direction of the tears and change the energy loss degree in the flowing process of the tears, thereby adjusting the outflow speed of the tears and meeting the aim of conveniently controlling the outflow of the tears.

In addition to the above-mentioned thread and boss solution, the present invention provides another preferable solution, wherein the protrusion is a protrusion strip, the protrusion strip protrudes from the body along the radial direction thereof, and the protrusion strip is continuously arranged along the body from top to bottom or from top to bottom with a certain angle of deflection; the protruding strips are one or two or more than two arranged along the circumferential direction of the body at intervals.

In the technical scheme, each protruding strip penetrates through the body up and down, and if one protruding strip is arranged, tear channels are formed on two sides of the protruding strip. If there are two or more protruding strips, a tear channel is formed between two adjacent protruding strips.

Further preferably, the shape of the boss may be sheet-like, hemispherical, cylindrical or prismatic, even irregular, etc.

Further preferably, the shape of the protruding strip may be a sheet, a hemisphere, a cylinder or a prism, or even an irregular shape.

Further preferably, the contact part of the left-handed thread or the right-handed thread and the lacrimal canaliculus is a sharp angle or a circular arc.

Among this technical scheme, the structure of screw thread and lacrimal canaliculus contact department is closed angle or circular arc, and closed angle scheme makes the lacrimal canaliculus embolism settle more firmly in the lacrimal canaliculus, and the closed angle scheme makes the lacrimal canaliculus embolism settle more comfortablely in the lacrimal canaliculus.

Similar to the previous technical proposal, the contact part of the lug boss and the lacrimal canaliculus is a sharp angle or a circular arc. The contact part of the convex strip and the lacrimal canaliculus is a sharp angle or a circular arc.

Further preferably, the lacrimal canaliculus plug is in an interference fit with the lacrimal canaliculus.

In the technical scheme, the lacrimal canaliculus plug is in interference fit with the lacrimal canaliculus, and the lacrimal canaliculus plug is not easy to slip from the lacrimal canaliculus, so that the long-acting property of use is ensured.

Further preferably, the punctal plug is made of polyisobutylene-based thermoplastic elastomer material.

In the technical scheme, due to the adoption of novel design and materials, the elastic lacrimal duct embolism based on the polyisobutylene can reduce foreign body sensation and uncomfortable sensation.

Further preferably, the lacrimal canaliculus embolism length is 1.0 mm-1.5 mm; the diameter range of the outer edge of the lacrimal duct embolism is 0.5-1.5 mm.

In the technical scheme, the requirements of users with different lacrimal duct embolism can be met by adjusting the length of the lacrimal duct embolism and the diameter of the outer edge of the lacrimal duct embolism.

Further preferably, the punctal plug is made of a block copolymer material based on a polyisobutylene [ polyisobutylene (pib) ] block comprising a rubbery polyisobutylene polymer, and a glassy or crystalline thermoplastic polymer.

In the technical scheme, the polyisobutylene block polymer has the elasticity of rubber, the melt thermal processing performance of plastics, and particularly has excellent biocompatibility and biological stability (does not degrade in a human body and does not cause foreign body reaction). The excellent biostability of polyisobutylene material block polymers is benefited by their special saturated molecular structure: no double bond, no long chain branch and no asymmetric carbon atom. In particular, the absence of asymmetric carbon atoms makes the polyisobutylene block non-existent a chemical route that can be dehydrogenated, while polyethylene and polypropylene materials have some degradation or crosslinking in the human body due to dehydrogenation.

Further preferably, the punctal plug is made of a linear triblock copolymer material based on polyisobutylene [ polyisobutylene (pib) ] blocks, the linear triblock copolymer being a thermoplastic polymer block with glassy or crystalline ends and the central block being a rubbery polyisobutylene polymer.

Further preferably, the punctum plug is made of a linear triblock copolymer thermoplastic elastomer SIBS alone or by melt blending with silver nanoparticles; the SIBS is a polystyrene-b-polyisobutylene-b-polystyrene [ poly (styrene-block-isoprene-block-styrene) ] triblock polymer.

In the technical scheme, the material for preparing the lacrimal duct embolism is preferably a linear triblock copolymer based on polyisobutylene [ Polyisobutylene (PIB) ] block, and the structural characteristics of the linear triblock copolymer are as follows: the two terminal glassy or crystalline (i.e., glass transition temperature or melting point above human body temperature) thermoplastic polymer blocks, while the central block is a rubbery (i.e., glass transition temperature or melting point below human body temperature) polyisobutylene polymer. SIBS (i.e., polystyrene-b-polyisobutylene-b-polystyrene) is preferably used as a material for preparing the lacrimal duct plug. The SIBS has excellent biological stability, biocompatibility, mechanical elasticity and processability as a triblock copolymer thermoplastic elastomer. In the human body temperature state, the high molecular weight PIB is a soft rubbery elastomer material; in contrast, PS (polystyrene) blocks are glassy plastics. The special triblock [ hard (PS) - -soft (PIB) - -hard (PS) ] molecular structure enables the SIBS material to have good mechanical elasticity. And by adjusting the relative amount of the polystyrene and the polyisobutylene, the SIBS elastomer material with proper hardness can be optimized. In addition, compared with the traditional organic silicon material, the SIBS has no obvious inflammation and foreign body reaction clinically after being implanted into eyes.

The polystyrene blocks as hard segments can be replaced by other glassy or crystalline polymers, provided that the latter have no degradable groups or groups which can cause toxic side effects. The polymer can be poly-alpha-methyl styrene, polymethyl methacrylate, vinyl benzene such as polyethyl methacrylate, methacrylate polymer, or their mixture.

Silver particles are a broad spectrum antimicrobial component. The dispersed nano silver particles not only have the antibacterial and anti-inflammatory effects, but also help to overcome the problem that the embolism made of polymer materials is difficult to position and detect. The SIBS and the nano silver particles are fused and blended, so that the advantages of the two materials can be integrated, the problems of foreign body sensation and foreign body reaction caused by unmatched mechanical flexibility (or high hardness) of the materials are solved, and the problems of X-ray, CT, nuclear magnetic resonance and the like in medical detection are easily positioned and detected due to the fact that the silver is a metal material, so that convenience is provided for subsequent medical treatment.

The lacrimal duct embolism provided by the invention can bring at least one of the following beneficial effects:

1. the invention creatively changes the lacrimal passage from the inner wall passage in the common knowledge to the outer wall passage, and the bulge not only serves as a structure for forming the lacrimal passage, but also serves as a structure for clamping the lacrimal duct embolism in the lacrimal duct to fix the lacrimal duct embolism. The polyisobutylene-based thermoplastic elastomer material, typified by SIBS, is chosen as the canaliculus-making material due to considerations of human comfort and long-term implantability. Compared with the lacrimal passage in the body, the lacrimal passage avoids the passage blockage caused by the deformation of the lacrimal canaliculus on the outer side of the body, so that the lacrimal fluid flows out more smoothly. Moreover, compare traditional cavity tubulose and solid column lacrimal canaliculus embolism, the lacrimal canaliculus embolism among this technical scheme is only contacted with the lacrimal canaliculus wall by the outer fringe of bulge, and the reduction patient foreign body sensation and anaphylactic reaction as far as possible have improved the use and have experienced.

2. The tear passage is formed by left or right hand threads around the body with the surface of the threads and a portion of the outer wall of the body together forming a wall of the tear passage.

3. The tear channel may also be formed by projections around the body, said projections projecting from the body in the radial direction thereof, the peripheral wall of each of said projections being slotted. Through the relative arrangement or the dislocation arrangement of the grooves, the flow direction of the tears is adjusted, and the energy loss degree in the flow process of the tears is changed, so that the outflow speed of the tears can be adjusted, and the aim of conveniently controlling the outflow of the tears is fulfilled.

4. The tear channel may also be formed by a protruding strip around the body, said protruding strip protruding from the body in its radial direction. The protruding strips penetrate through the body from top to bottom or spirally, and a tear channel is formed by the groove between every two adjacent protruding strips.

5. The outer edge of the screw thread, the lug boss and the protruding strip are easy to support on the wall of the lacrimal canaliculus, the support performance is good, the processing is very convenient, and the requirements of different degrees of lacrimal canaliculus embolism are met.

6. The structure of the contact part of the screw thread, the boss or the protruding strip and the lacrimal canaliculus is a sharp angle or a circular arc, the arrangement of the lacrimal canaliculus plug in the lacrimal canaliculus is firmer by the scheme of the sharp angle, and the arrangement of the lacrimal canaliculus plug in the lacrimal canaliculus is more comfortable by the scheme of the circular arc.

7. The invention creatively combines the design of the outer wall channel with the SIBS elastomer material with excellent biocompatibility and biostability to prepare a new generation lacrimal duct embolism product. The device has the advantages of simple structure, reliable and stable positioning, greatly reduced occurrence probability of foreign body reaction and tissue inflammation, wide market prospect, strong market competitiveness and good social benefit.

Drawings

The foregoing features, technical features, advantages and modes of realisation of the punctal plugs will be further described in the following, in a clearly understandable manner, with reference to the accompanying drawings, which illustrate preferred embodiments.

FIG. 1 is a schematic view of a first embodiment of a punctal plug structure according to the invention;

FIG. 2 is a schematic view of a plug structure of a lacrimal canaliculus according to a second embodiment of the present invention;

FIG. 3 is a schematic top view of FIG. 2;

FIG. 4 is a schematic illustration of a punctal plug according to an embodiment of the invention applied to the punctal canal;

FIG. 5 is a schematic view of a plug structure of a lacrimal canaliculus according to a second embodiment of the present invention;

FIG. 6 is a schematic view of a fourth embodiment of a punctal plug structure according to the invention;

FIG. 7 is a schematic top view of FIG. 6;

FIG. 8 is another top schematic view of FIG. 6;

FIG. 9 is a further top schematic view of FIG. 6;

FIG. 10 is a schematic view of a plug structure of a lacrimal canaliculus according to a ninth embodiment of the present invention;

FIG. 11 is a schematic top view of FIG. 10;

FIG. 12 is a schematic view of a plug structure of a lacrimal canaliculus according to a tenth embodiment of the present invention;

FIG. 13 is a schematic view of a punctal plug according to an eleventh embodiment of the invention;

FIG. 14 is a schematic view of a plug structure of a lacrimal canaliculus according to a twelfth embodiment of the present invention;

FIG. 15 is a schematic chemical structure of SIBS.

The reference numbers illustrate:

the right-handed thread 1, the body 2, the projection 21, the tear channel 3, the inner wall of the lacrimal canaliculus 4, the boss 5, the groove 6 and the projection strip 7.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.

For the sake of simplicity, the drawings only schematically show the parts relevant to the present invention, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".

In the first embodiment, as shown in fig. 1. A lacrimal canaliculus plug, comprising: a body 2 extending in the axial direction of the lacrimal canaliculus; the outer side wall of the body 2 is provided with a convex part 21 extending towards the canaliculus wall 4, and the surface of the convex part 21 and at least a part of the outer wall of the body 2 form a tear channel 3. The specific shape of the protruding portion 21 is not limited in this embodiment, and may be hemispherical, cylindrical or prismatic with a part of spherical surface at the top, cylindrical or prismatic with a sharp top, or even irregular. Shown in fig. 1 in the form of a cylindrical protrusion with a part spherical top.

In the present embodiment, the lacrimal passage 3 is creatively changed from the inner wall passage in the general knowledge to the outer wall passage, and the protrusion 21 not only serves as a structure for forming the lacrimal passage but also serves as a structure for blocking the lacrimal duct plug in the lacrimal duct to fix the lacrimal duct plug. Because the comfort of the human body is considered, the lacrimal canaliculus is made of elastic materials preferably, compared with the lacrimal passage 3 in the body 2, the lacrimal passage 3 outside the body 2 avoids the passage blockage caused by the deformation of the lacrimal canaliculus, so that the lacrimal fluid flows out more smoothly; in addition, compared with the traditional hollow tubular and solid columnar lacrimal duct embolism, the lacrimal duct embolism only contacts the lacrimal duct inner wall 4 from the outer edge of the convex part 21, so that the foreign body sensation and anaphylactic reaction of a patient are reduced as much as possible, and the use experience is improved; moreover, the entire side wall of the conventional hollow tubular lacrimal canaliculus plug or the solid plug is almost in close contact with the inner wall of the lacrimal canaliculus, so that bacteria may be accumulated between the lacrimal canaliculus plug and the inner wall of the lacrimal canaliculus and cannot be discharged, thereby causing inflammation or discomfort. The bulge 21 is in small-area contact with the inner wall 4 of the lacrimal canaliculus, so that substances such as bacteria, protein and the like can flow away with tears, and the inflammation risk is reduced.

It is worth noting that the punctal plug of this example can be implanted in the lacrimal canaliculus (lacrimal passage).

In the second embodiment, as shown in fig. 2-4, on the basis of the first embodiment, the protrusion 21 is a left-handed thread or a right-handed thread surrounding the body, and the tear passage 3 is formed by a left-handed thread surface or a right-handed thread surface and a part of the outside of the body 2. The form shown in fig. 2-4 is a right-hand thread. It will be appreciated that left hand threads are also equivalent. In the embodiment, the surface of the screw thread and a part of the outer wall of the body 2 jointly form the wall of the lacrimal passage 3, the outer edge of the screw thread is supported on the inner wall 4 of the lacrimal canaliculus, the support performance is good, the screw thread processing is very convenient, and the requirements of different degrees of lacrimal canaliculus embolism are met.

In the third embodiment, as shown in fig. 5, the flow rate of tear fluid can be adjusted by changing the pitch of the left-hand thread or the right-hand thread of the body 2 based on the second embodiment. In this embodiment, the outflow rate of tears is adjusted by adjusting the pitch of the thread (in the case that the inner and outer diameters of the thread are fixed, adjusting the pitch is also equivalent to adjusting the helix angle) to meet the requirements of different degrees of punctum embolism.

In the fourth embodiment, as shown in fig. 6 to 7, on the basis of the first embodiment, the projection 21 is a boss 5, the boss 5 is projected from the body 2 in the radial direction thereof, and at least one boss 5 is provided; the peripheral wall of each boss 5 is provided with a groove 6 which forms a tear channel 3 with at least a part of the outer wall of the body 2. In the embodiment, the outflow rate of tears can be adjusted by changing the number of the bosses 5, the opening angle of the groove 6, the opening depth of the groove 6 and the number of the grooves 6, so as to meet the requirements of different lacrimal duct embolism degrees. In the fifth embodiment, on the basis of the fourth embodiment, the bosses 5 are arranged at intervals in the axial direction, or two or more than two. In the embodiment, the stability of the lacrimal duct plug placed in the lacrimal duct can be adjusted by changing the number of the bosses 5, and two or more of the structures are more stable.

In the sixth embodiment, as shown in fig. 7-9, on the basis of the fifth embodiment, each boss 5 is provided with at least one groove 6, or two or more grooves 6. Fig. 7 shows four slots 6, fig. 8 shows one slot 6, and fig. 9 shows two slots 6. In the embodiment, the outflow rate of tears is adjusted by adjusting the number of the grooves 6 so as to meet the requirements of different lacrimal canaliculus embolism degrees.

In the seventh embodiment, as shown in fig. 7 to 9, in the sixth embodiment, when the number of the grooves 6 is two or more, the grooves 6 are uniformly distributed in the circumferential direction of the body. In this embodiment, it is comparatively convenient that 6 circumference equipartitions of groove are processed.

In the eighth embodiment, in addition to the sixth embodiment, when there are two or more bosses 5, the grooves 6 of two adjacent bosses 5 are disposed to face each other or are disposed to be shifted from each other. The relative arrangement means that the grooves 6 of the upper and lower different bosses 5 are all arranged at the same position; the staggered arrangement means that the starting positions of the grooves 6 of different bosses 5 are different and are staggered with each other. In the embodiment, the grooves 6 are oppositely arranged or staggered so as to adjust the flow direction of the tears and change the energy loss degree in the flowing process of the tears, so that the outflow speed of the tears can be adjusted, and the aim of conveniently controlling the outflow of the tears is fulfilled. A misaligned channel 6 will typically have a slower tear flow rate than the opposite channel.

In the fourth, fifth, sixth, seventh and eighth embodiments, the specific shape of the boss is not limited, and may be a sheet, a hemisphere, a cylinder or a prism, or even an irregular shape. The form of the bosses shown in figures 6, 7, 8 and 9 is by way of example a sheet.

In the ninth embodiment, as shown in fig. 10 to 11, on the basis of the first embodiment, the projecting portion 21 is a projecting strip 7, the projecting strip 7 projects from the body 2 in the radial direction thereof, and the projecting strip 7 is continuously arranged from above and up and down along the body 2; the protruding strips 7 are one or two or more arranged at intervals along the circumferential direction of the body 2. In this embodiment, each of the protrusion strips 7 vertically penetrates the body 2, and if there is one protrusion strip 7, tear channels are formed on both sides of the protrusion strip 7. If there are two or more projected strips 7, a tear passage 3 is formed between adjacent two projected strips 7. The number of the protruding strips 7 is 3 or more stable. The contact part of the convex strip 7 and the lacrimal canaliculus is a sharp angle or a circular arc. Fig. 14 shows a rounded corner form. It can be understood that sharp corners can be treated similarly. In this embodiment, the contact part of the protrusion strip 7 and the lacrimal canaliculus is in the form of an arc or a sharp corner, the arrangement of the sharp corner makes the lacrimal canaliculus plug more firmly arranged in the lacrimal canaliculus, and the arrangement of the lacrimal canaliculus plug in the lacrimal canaliculus is more comfortable by the round corner arrangement.

In the tenth embodiment, as shown in fig. 5 and 12, on the basis of the second or third embodiment, the contact part of the left-handed thread or the right-handed thread with the lacrimal canaliculus is a sharp corner (as shown in fig. 5) or a circular arc (as shown in fig. 12). In this embodiment, the structure of screw thread and lacrimal canaliculus contact department is closed angle or circular arc, and closed angle scheme makes the lacrimal canaliculus plug settle more firmly in the lacrimal canaliculus, and the rounded angle scheme makes the lacrimal canaliculus plug settle more comfortablely in the lacrimal canaliculus.

In the eleventh embodiment, as shown in fig. 6 and 13, on the basis of the fourth, fifth, sixth, seventh or eighth embodiments, the contact portion of the projection 5 with the lacrimal canaliculus is a sharp corner (as in fig. 5) or a circular arc (as in fig. 13). In this embodiment, the structure of the contact part of the boss 5 and the lacrimal canaliculus is a sharp angle or an arc, the sharp angle scheme enables the lacrimal canaliculus plug to be more firmly arranged in the lacrimal canaliculus, and the round angle scheme enables the lacrimal canaliculus plug to be more comfortably arranged in the lacrimal canaliculus.

In a twelfth embodiment, shown in fig. 14, a punctal plug, comprising: a body 2 extending in the axial direction of the lacrimal canaliculus; the outer side wall of the body 2 is provided with a convex part extending towards the canaliculus wall 4, and the surface of the convex part and at least a part of the outer wall of the body 2 form a tear channel 3. The protruding portion is a protruding strip 7, the protruding strip 7 protrudes from the body 2 along the radial direction thereof, and the protruding strip 7 is continuously arranged from the top and the bottom along the body 2. And the convex strip 7 deflects a certain angle (can deflect left or right) along the outer surface of the body 2 from top to bottom. The protruding strips 7 are one or two or more arranged at intervals along the circumferential direction of the body 2. In this embodiment, each of the protrusion strips 7 vertically penetrates the body 2, and if there is one protrusion strip 7, tear channels are formed on both sides of the protrusion strip 7. If there are two or more projected strips 7, a tear passage 3 is formed between adjacent two projected strips 7. The number of the protruding strips 7 is 3 or more stable. Fig. 14 exemplifies 4 projecting strips 7. The contact part of the convex strip 7 and the lacrimal canaliculus is a sharp corner or a circular arc. Fig. 14 shows a rounded corner form. It can be understood that sharp corners can be treated similarly. The pointed angle scheme makes the lacrimal duct plug place more firmly in the lacrimal duct, and the fillet scheme makes the lacrimal duct plug place more comfortablely in the lacrimal duct.

In example thirteen, based on examples one, two, three, four, five, six, seven, eight, nine, ten, eleven, or twelve, the lacrimal canaliculus plug is an interference fit with the lacrimal canaliculus. In the embodiment, the lacrimal duct embolism is in interference fit with the lacrimal duct, and the lacrimal duct embolism is not easy to slip from the lacrimal duct, so that the long-acting performance of use is ensured.

In example fourteen, based on examples one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, a polyisobutylene-based elastomeric material was used for the lacrimal duct plug. In this embodiment, the polyisobutylene elastomer based punctum plug reduces the foreign body sensation and discomfort.

In the fifteenth embodiment, based on the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, and fourteenth embodiments, the lacrimal canaliculus plug length is 1.0mm to 1.5 mm; the diameter range of the outer edge of the lacrimal duct embolism is 0.5-1.5 mm. In the embodiment, the requirement of different lacrimal duct embolism users can be met by adjusting the length of the lacrimal duct embolism and the diameter of the outer edge of the lacrimal duct embolism.

In a sixteenth embodiment, as shown in fig. 15, based on the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth embodiments, the punctal plugs are preferably made of a linear triblock copolymer material based on polyisobutylene [ polyisobutylene (pib) ] blocks. The molecular structure is characterized in that: the two terminal glassy or crystalline (i.e., glass transition temperature or melting point above human body temperature) thermoplastic polymer blocks, while the central block is a rubbery (i.e., glass transition temperature or melting point below human body temperature) polyisobutylene polymer. SIBS (i.e., polystyrene-b-polyisobutylene-b-polystyrene) is preferably used as a material for preparing the lacrimal duct plug. The lacrimal duct embolism is made by the SIBS alone or by the fusion and blending with the nano silver particles.

SIBS is Polyisobutylene (PIB)]A linear triblock copolymer that is a mid-block. In this example, SIBS has excellent biostability, biocompatibility, mechanical elasticity, and processability as a triblock copolymer. Due to thermodynamic incompatibility and the molecular structural characteristics of triblock polymers, Polystyrene (PS) and Polyisobutylene (PIB) self-aggregate to form ordered microstructures. High glass state temperature (> body temperature, T)_b) The hard segment (hard) domain of polystyrene has a low glass state temperature (< body temperature, T)_b) The amorphous polyisobutylene soft segment (soft) domains provide physical crosslinking points to make the whole material at body temperature (T)_b) Environmentally behaves as an elastomer. The mechanical properties such as elastic modulus, hardness, elongation and the like required by the material can be realized by performing molecular design through a living cationic polymerization means. The specific method comprises the following steps: adjusting the size of the overall molecular weight, the block length of the Polystyrene (PS) and the Polyisobutylene (PIB), the block length ratio (S/IB), and the like. The triblock copolymer exhibits the molecular structural characteristics of "hard segment (hard) - - -soft segment (soft) - - -hard segment (hard)". Through molecular design, the flexibility of the material is matched with the tissue of an implantation position, so that foreign body reaction caused by overhigh hardness of an implantation instrument is reduced. And because the structural components of the SIBS have excellent biocompatibility and biostability, tissue inflammatory reaction caused by small molecular substances released by material degradation (due to long-term implantation) is avoided. The nano silver particle is a broad-spectrum antibacterial compositionAnd (4) dividing. The dispersed nano silver particles not only have the antibacterial and anti-inflammatory effects, but also help to overcome the problem that the punctum embolism made of the polymer material is difficult to position and detect. The SIBS and the nano silver particles are fused and blended, so that the advantages of the two materials can be integrated, the problems of foreign body sensation and foreign body reaction caused by unmatched mechanical flexibility (or high hardness) of the materials can be solved, and the X-ray, CT, nuclear magnetic resonance and the like used for medical detection are easy to position and detect due to the fact that the silver is a metal material, so that convenience is provided for subsequent medical treatment.

In all the above embodiments, the drawings are schematic views, and the transition, sharp corner, round corner, machining error and the like are inevitably formed due to the material machining, and are included in the scope of the present invention.

It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention. And it should be noted that it would be apparent to those skilled in the art that various modifications and enhancements may be made without departing from the principles of the invention, and such modifications and enhancements are also considered to be within the scope of the invention.

Claims

1. A punctal plug, comprising:

a body extending in an axial direction of a lacrimal canaliculus;

2. The punctal plug of claim 1, wherein:

the projection is a left-hand thread or a right-hand thread around the body, and the tear channel is formed by the left-hand thread or the right-hand thread and a portion of the outer wall of the body.

3. The punctal plug of claim 2, wherein:

the pitch of the left or right hand threads is varied to adjust tear flow rate.

4. The punctal plug of claim 1, wherein:

the peripheral wall of each boss is provided with a groove, and the groove wall and at least one part of the outer wall of the body form the tear channel.

5. The punctal plug of claim 4, wherein:

the boss is one, or two or more than two axially spaced arrangement.

6. The punctal plug of claim 5, wherein:

each boss is provided with one groove or two or more grooves.

7. The punctal plug of claim 6, wherein:

when the grooves are more than two, the grooves are uniformly distributed along the circumferential direction of the body.

8. The punctal plug of claim 4, wherein:

when the number of the bosses is more than two, the grooves of two adjacent bosses are oppositely arranged or arranged in a staggered way.

9. The punctal plug of claim 1, wherein:

the convex part is a convex strip, the convex strip is protruded from the body along the radial direction of the body, and the convex strip is arranged continuously along the body from top to bottom or from top to bottom by deflecting a certain angle;

the protruding strips are one or two or more than two arranged along the circumferential direction of the body at intervals.

10. The punctal plug of any one of claims 4-8, wherein:

the shape of the boss can be sheet-shaped, hemispherical, cylindrical or prismatic, even irregular, and the like.

11. The punctal plug of any one of claim 9, wherein:

the shape of the protruding strip can be sheet-shaped, hemispherical, cylindrical or prismatic, even irregular, and the like.

12. The punctal plug of claim 2 or 3, wherein:

the contact part of the left-handed thread or the right-handed thread and the lacrimal canaliculus is a sharp angle or an arc.

13. The punctal plug of any one of claims 4-8, wherein:

the contact part of the boss and the lacrimal canaliculus is a sharp angle or an arc.

14. The punctal plug of claim 9, wherein:

the contact part of the convex strip and the lacrimal canaliculus is a sharp angle or a circular arc.

15. The punctal plug of claim 1, wherein:

the lacrimal canaliculus plug is in interference fit with the lacrimal canaliculus.

16. The punctal plug of claim 1, wherein:

the lacrimal duct plug adopts polyisobutylene-based thermoplastic elastic material.

17. The punctal plug of claim 1, wherein:

the length of the lacrimal duct embolism is 1.0 mm-1.5 mm;

the diameter range of the outer edge of the lacrimal duct embolism is 0.5-1.5 mm.

18. The punctal plug of claim 1, wherein:

the punctal plugs are preferably made from block copolymer materials based on polyisobutylene blocks, including rubbery polyisobutylene polymers, and glassy or crystalline thermoplastic polymers.

19. The punctal plug of claim 18, wherein:

the punctal plugs are made of a block copolymer material based on polyisobutylene blocks that terminate in a glassy or crystalline thermoplastic polymer block and terminate centrally in a rubbery polyisobutylene polymer.

20. The punctal plug of claim 19, wherein:

the punctal plugs are made of a linear triblock copolymer material based on polyisobutylene blocks, the linear triblock copolymer being a thermoplastic polymer block with glassy or crystalline ends and the central block being a rubbery polyisobutylene polymer.

21. The punctal plug of claim 20, wherein:

the lacrimal duct embolism is made by the linear triblock copolymer thermoplastic elastomer SIBS alone or by the melt blending with nano silver particles; the SIBS is polystyrene-b-polyisobutylene-b-polystyrene, which is a linear triblock copolymer with polyisobutylene as a midblock.