WO2020011215A1 - 一种泪小管栓塞 - Google Patents

一种泪小管栓塞 Download PDF

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Publication number
WO2020011215A1
WO2020011215A1 PCT/CN2019/095509 CN2019095509W WO2020011215A1 WO 2020011215 A1 WO2020011215 A1 WO 2020011215A1 CN 2019095509 W CN2019095509 W CN 2019095509W WO 2020011215 A1 WO2020011215 A1 WO 2020011215A1
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WIPO (PCT)
Prior art keywords
lacrimal
embolism
canaliculus
lacrimal canaliculus
duct
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PCT/CN2019/095509
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English (en)
French (fr)
Inventor
吴坚
周永华
李刚
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吴坚
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Publication of WO2020011215A1 publication Critical patent/WO2020011215A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Definitions

  • the present disclosure relates to the field of medical devices, and in particular, to a lacrimal ductal embolism.
  • Dry eye disease also known as dry eye and dry corneal and conjunctival disease (KCS)
  • KCS dry eye disease
  • the global incidence is high, and the cause is not entirely clear.
  • any imbalance in tear production and drainage and tear film dysfunction can cause dry eye.
  • the most common ones are systemic xerophthalmia syndrome, refractive corneal surgery, anterior segment burns, and computer radiation.
  • Dry eye is a common and frequently-occurring disease in ophthalmology. Especially for patients with long-term dry eyes, symptoms such as dryness, red eyes, itching, burning, foreign body sensation, tingling, tearing, photophobia, decreased vision, and tired eyes often cause great pain to patients. Severe dry eye disease will cause a series of ocular surface diseases, such as: corneal epithelial defects, conjunctival or corneal degeneration, sterile corneal ulcers, and infectious corneal ulcers.
  • Conservative treatment includes methods such as tear substitutes, promotion of tear secretion, and preservation of tears, such as: 1) Artificial tears can be similar to wet, lubricated, and nourishing corneal and conjunctiva. The role of natural tears; 2) the use of drugs (cyclosporine A, glucocorticoids, androgen steroids, brom benzyl cyclohexylamine, etc.) to regulate immune function and promote lacrimal gland tissue and salivary gland tissue secretion.
  • drugs cyclosporine A, glucocorticoids, androgen steroids, brom benzyl cyclohexylamine, etc.
  • Lacrimal duct embolism used clinically is usually divided into degradable and permanent (non-degradable), and for patients with moderate to severe dry eye, permanent lacrimal duct embolism is mainly used.
  • Silicone material has good biocompatibility and biological stability, good mechanical elasticity, and easy to process.
  • silica silica
  • oligomer oligomer
  • cyclic monomer in the preparation process of the silica gel material. The long-term existence of these impurities can cause foreign body reaction.
  • the purpose of the present disclosure is to provide a lacrimal canaliculus embolism, which makes the excretion rate of tear fluid relatively controllable and avoids the embolism from slipping, so as to meet the long-term needs of patients with different degrees of dry eye symptoms.
  • a lacrimal canaliculus embolus comprising:
  • a body extending along the axis of the lacrimal canaliculus
  • the outer side wall of the body has a protrusion extending in the direction of the lacrimal canaliculus tube wall, and the surface of the protrusion and at least a part of the outer wall of the body form a lacrimal external passage.
  • the tear channel is creatively changed from the inner wall channel (or “inner channel”) to the outer wall channel (or “outer channel”) in common sense, and the protrusion not only serves as a structure forming the outer channel of tears It is a structure that fixes a lacrimal canaliculus embolism by trapping it in the lacrimal canaliculus.
  • lacrimal tubules are made of polyisobutylene elastomers with excellent biocompatibility and biostability.
  • the lacrimal duct embolism in this technical solution is only in contact with the lacrimal duct wall by the outer part of the protrusion (including the outer edge), and uses a more comfortable polyisobutylene Elastomer material, to reduce the patient's foreign body sensation and allergic reaction as much as possible, and improve the use experience.
  • the protruding portion is a left-handed thread or a right-handed thread surrounding the body
  • the tear fluid external channel is formed by a left-handed thread surface or a right-handed thread surface and a part of the outer wall of the body.
  • the external tear fluid channel is composed of a left-handed thread or a right-hand thread that surrounds the body.
  • the surface of the thread and a part of the outer wall of the body jointly constitute the wall of the external tear fluid channel.
  • changing the pitch of the left-handed thread or the right-handed thread of the body can adjust the tear flow rate.
  • changing the thread width of the left-handed thread or the right-handed thread of the body can adjust the tear flow rate.
  • the width of the thread is adjusted to adjust the outflow rate of tears, thereby meeting the needs of patients with different degrees of dry eye symptoms.
  • this disclosure also provides another preferred scheme,
  • the protrusion is a boss, the boss is protruded by the body in a radial direction thereof, and the boss is at least one;
  • a groove is formed in an outer peripheral wall of each of the bosses, and the groove wall and at least a part of the outer body wall form the tear fluid external channel.
  • the tear fluid outflow rate can be adjusted by changing the number of bosses, the opening angle of the grooves, the opening depth of the grooves, and the number of grooves to meet the requirements of different degrees of lacrimal ductal embolism.
  • the boss is one or two or more axially spaced apart.
  • the stability of the lacrimal canaliculus embolism placed in the lacrimal canaliculus can be adjusted by changing the number of bosses, and two or more are more stable.
  • each of the protrusions is provided with at least one of the grooves, or two or more grooves.
  • the number of troughs is adjusted to adjust the outflow rate of tear fluid to meet the requirements of different degrees of lacrimal ductal embolism.
  • the grooves are evenly distributed along the circumferential direction of the body.
  • the grooves of two adjacent protrusions are oppositely disposed or offset.
  • the relative or misalignment of the grooves is used to adjust the tear flow direction and change the degree of energy loss during the tear flow, so that the tear flow speed can be adjusted to meet the purpose of convenient control of tear flow.
  • the present disclosure also provides another preferred solution, wherein the protruding portion is a protruding bar, the protruding bar is protruded by the body in a radial direction thereof, and the protruding bar is straight up Straight down or deflected at a certain angle continuously arranged along the body from top to bottom; one or two or more protruding strips are arranged at intervals along the circumferential direction of the body.
  • the protruding portion is a protruding bar
  • the protruding bar is protruded by the body in a radial direction thereof, and the protruding bar is straight up Straight down or deflected at a certain angle continuously arranged along the body from top to bottom; one or two or more protruding strips are arranged at intervals along the circumferential direction of the body.
  • each protruding strip runs up and down the body, and if there is a protruding strip, a tear fluid channel is formed on both sides of the protruding strip. If there are two or more protruding strips, an external tear fluid channel is formed between two adjacent protruding strips.
  • the shape of the boss may be a sheet shape, a hemispherical shape, a cylindrical or prismatic shape, or even an irregular shape.
  • an outer shape of the protruding strip may be a sheet shape, a hemispherical shape, a cylindrical or prismatic shape, or even an irregular shape.
  • the contact point of the left-hand thread or the right-hand thread with the lacrimal canaliculus is a sharp angle or an arc or a plane.
  • the structure where the thread contacts the lacrimal canaliculus is a sharp corner or an arc or a plane.
  • the sharp corner scheme makes the lacrimal canaliculus embolism more securely placed in the lacrimal canaliculus
  • the rounded corner scheme makes the lacrimal canaliculus embolism placed in the lacrimal canaliculus. More comfortable.
  • the contact point between the boss and the lacrimal canaliculus is a sharp angle or an arc or a plane.
  • the contact point between the protruding strip and the lacrimal canaliculus is a sharp corner or an arc or a plane.
  • the lacrimal canaliculus embolism is in interference fit with the lacrimal canaliculus.
  • the lacrimal canaliculus embolism cooperates with the lacrimal canaliculus interference, and the lacrimal canaliculus embolism is not easy to slip out of the lacrimal canaliculus, ensuring long-term use.
  • the length of the lacrimal canaliculus embolism is 0.5 mm to 3.0 mm; and the diameter of the outer edge of the lacrimal canaliculus embolism is 0.2 mm to 2.0 mm.
  • the inside of the body is a hollow tear fluid channel.
  • a combination of internal tear fluid channels and external tear fluid channels is used to expand the controllable range and operability of the tear flow velocity.
  • the bulge plays a role in fixing the embolism in the lacrimal canaliculus.
  • the external channel of the tear fluid (that is, the channel outside the embolus body) has the function of controlling the flow of tear fluid.
  • the internal channel of tear fluid (the channel inside the embolus body) mainly controls the speed of tear fluid out .
  • the purpose of this solution is that once the external tear channel or internal tear channel is blocked, the other channel can continue to play the role of draining tears, thereby extending the life of the lacrimal ductal embolism in design. If the lacrimal canaliculus is completely blocked, it will increase the chance of inflammatory side reactions in this area.
  • the lacrimal ductal embolism is made of a polyisobutylene-based thermoplastic elastic material.
  • polyisobutylene-based elastic lacrimal ductal embolism can reduce foreign body sensation and discomfort.
  • the lacrimal canaliculus embolism is made of a block copolymer material based on a polyisobutylene (PIB) block, the block including a rubbery polyisobutylene polymer, and a glassy or crystalline thermoplastic polymer Thing.
  • PIB polyisobutylene
  • the polyisobutylene block polymer not only has the elasticity of rubber, but also has the hot-melt processing properties of plastics, especially has excellent biocompatibility and biological stability (does not cause allogeneic reactions in the human body, degradation).
  • the excellent biological stability of the polyisobutylene block polymer is due to the special saturated molecular structure of the rubbery polyisobutylene block: no double bonds, no long-chain branches, and no asymmetric carbon atoms.
  • the absence of asymmetric carbon atoms makes the polyisobutylene block free from chemical pathways that can be dehydrogenated, and polyethylene and polypropylene materials have some degradation or cross-linking in the human body due to dehydrogenation.
  • the lacrimal canaliculus embolism is made of a linear triblock copolymer material based on a polyisobutylene (PIB) block, and the linear triblock copolymer is a thermoplastic polymerization in a glassy state or a crystalline state at both ends.
  • Material block, the central block is a rubbery polyisobutylene polymer.
  • the lacrimal canaliculus embolism is made of a linear triblock copolymer thermoplastic elastomer SIBS alone or by melt blending with nano-silver particles;
  • SIBS is polystyrene-b-polyisobutylene-b-polybenzene Ethylene [poly (styrene-block-isobutylene-block-styrene)] triblock polymer.
  • the material for preparing the lacrimal canaliculus embolus is preferably a linear triblock copolymer based on polyisobutylene (PIB) blocks. Its structural characteristics are: glassy or crystalline (i.e., glass transition) at both ends. Temperature or melting point is higher than the temperature of the human body) thermoplastic polymer block, and the central block is rubbery (that is, the glass transition temperature or the melting point is lower than the temperature of the human body) polyisobutylene polymer.
  • SIBS that is, poly (styrene-block-isobutylene-block-styrene)
  • SIBS that is, poly (styrene-block-isobutylene-block-styrene)
  • SIBS as a triblock copolymer thermoplastic elastomer has excellent biological stability, biocompatibility, mechanical elasticity and processing properties.
  • high molecular weight PIB is a soft rubbery elastomer material; in contrast, PS (polystyrene) blocks are glassy plastics.
  • PS polystyrene
  • the special triblock [hard (PS)-soft (PIB)-hard (PS)] molecular structure makes SIBS materials have good mechanical elasticity.
  • SIBS elastomer materials with suitable soft hardness can be optimized.
  • SIBS has no clinically significant inflammation and allogeneic reactions after implantation into the eye.
  • polystyrene block as the hard segment can be replaced by other glassy or crystalline polymers, as long as the latter has no degradable groups or no degradable groups that cause toxic and side effects.
  • polystyrene such polymers also include vinyl benzene and methacrylate polymers such as poly alpha-methylstyrene, polymethyl methacrylate, and polyethyl methacrylate, or their mixture.
  • Silver particles are a broad-spectrum antibacterial ingredient.
  • the dispersed nano-silver particles not only have antibacterial and anti-inflammatory effects, but also help to overcome the problem of difficult to locate and detect plugs made of polymer materials. Melt blending of SIBS and nano-silver particles can combine the advantages of the two materials. On the one hand, it avoids the problem of foreign body sensation and foreign body reaction caused by the mismatch (or too high hardness) of the material's mechanical compliance (or hardness). On the one hand, because silver is a metal material, X-rays, CT, and nuclear magnetic resonance used in medical detection are easy to locate and detect, providing convenience for subsequent medical treatment.
  • the present disclosure creatively changes the tear fluid channel from an inner wall channel (or inner channel) in general common sense to an outer wall channel (or outer channel).
  • the protrusion not only serves as a structure forming the outer channel of tear fluid, but also serves as an embolization of the lacrimal canaliculi. Structure stuck in lacrimal canaliculi to fix lacrimal canaliculus embolism. Due to the consideration of human comfort and long-term implantability, lacrimal tubule manufacturing materials are selected from SIBS-based thermoplastic elastomers based on polyisobutylene.
  • the lacrimal ductal embolism in this technical solution only contacts the lacrimal duct wall by the outer part of the protrusion (including the outer edge), which minimizes the patient's foreign body sensation and allergic reaction. Improved user experience.
  • the width of the lacrimal external passage of the present disclosure depends on the difference between the outer diameter of the lacrimal canaliculus embolus and the body diameter. Changing the width of the outer channel can adjust the tear flow rate.
  • the design of multiple external tear ducts is used, which can more effectively avoid possible lacrimal duct obstruction and may (caused by obstruction of lacrimal duct) compared with the traditional hollow hollow duct tear duct design. Inflammatory response.
  • the controllable range and operability of the tear flow velocity can be further expanded.
  • the outer tear channel is composed of a left-handed thread or a right-handed thread that surrounds the body, and the surface of the thread and a part of the outer wall of the body together constitute the wall of the outer tear channel.
  • the tear duct may also be formed by a boss surrounding the body, the boss protruding from the body in its radial direction, and a groove is formed on the outer peripheral wall of each of the bosses.
  • the relative setting or misalignment of the grooves is used to adjust the tear flow direction and change the degree of energy loss during the tear flow, so that the tear flow speed can be adjusted to meet the purpose of convenient control of tear flow.
  • the tear duct can also be formed by a protruding strip surrounding the body, the protruding strip protruding from the body in its radial direction.
  • the protruding strips run through the body in a straight upward or downward or spiral shape from top to bottom, and a groove between two adjacent protruding strips forms an external tear fluid channel.
  • the design of the multiple tear fluid external channels thus formed can not only regulate the speed of tear fluid outflow, but also reduce the risk of possible tear clogging.
  • the outer part is easy to support on the wall of the lacrimal canaliculus, with good supportability and convenient processing, so as to meet different requirements of lacrimal canaliculus embolization.
  • the structure where the threads, bosses or protrusions contact the lacrimal canaliculus is sharp corners or arcs or planes.
  • the sharp angle scheme makes the lacrimal canaliculi embolized more securely in the lacrimal canaliculus.
  • the lacrimal canaliculus is more comfortable, and the flat surface can take into account both firmness and comfort.
  • This disclosure creatively combines the design of the outer wall channel (or outer channel) with the SIBS elastomer material with excellent biocompatibility and biological stability to prepare a new generation of lacrimal tubule embolism products. Its simple structure, reliable positioning and stability greatly reduce the incidence of allogeneic reactions and tissue inflammation. It has broad market prospects, fairly strong market competitiveness, and good social benefits.
  • FIG. 1 is a schematic structural diagram of a lacrimal ductal embolism according to an embodiment of the present disclosure
  • FIG. 2 is a schematic diagram of a lacrimal canaliculus embolization structure according to another embodiment of the present disclosure
  • FIG. 3 is a schematic plan view of FIG. 2;
  • FIG. 4 is a schematic diagram of a lacrimal canaliculus embolization applied to a lacrimal canaliculus according to an embodiment of the present disclosure
  • FIG. 5 is a schematic diagram of a lacrimal canaliculus embolization structure according to another embodiment of the present disclosure.
  • FIG. 6 is a schematic diagram of a lacrimal ductal embolism structure according to another embodiment of the present disclosure.
  • FIG. 7 is a schematic plan view of FIG. 6;
  • FIG. 8 is another schematic plan view of FIG. 6;
  • FIG. 9 is another schematic plan view of FIG. 6;
  • FIG. 10 is a schematic diagram of a lacrimal canaliculus embolization structure according to another embodiment of the present disclosure.
  • FIG. 10 is a schematic top view of FIG. 10;
  • FIG. 12 is a schematic diagram of a lacrimal canaliculus embolization structure according to another embodiment of the present disclosure.
  • FIG. 13 is a schematic diagram of a lacrimal canaliculus embolization structure according to another embodiment of the present disclosure.
  • FIG. 14 is a schematic diagram of a lacrimal canaliculus embolization structure according to another embodiment of the present disclosure.
  • 15 is a schematic diagram of a lacrimal canaliculus embolization structure according to another embodiment of the present disclosure.
  • FIG. 16 is a schematic top view of FIG. 15;
  • Figure 17 is a schematic diagram of the chemical structure of SIBS.
  • d1 is the outer tear duct embolism Diameter
  • d2 the diameter of the lacrimal canaliculus embolus
  • P is the pitch of the thread
  • L is the length of the lacrimal canaliculus embolism
  • ⁇ is the angle of the notch.
  • a lacrimal canaliculus embolus comprises: a body 2 extending along the axial direction of the lacrimal canaliculus; an outer side wall of the body 2 has a protruding portion 21 extending toward the lacrimal canalicular tube wall 4 (not shown), and a protruding portion 21
  • the surface and at least a part of the outer wall of the body 2 form an external tear fluid channel 3.
  • the specific shape of the protruding portion 21 is not limited in this embodiment, and may be a hemispherical shape, a cylindrical shape or a prism shape, a cylindrical shape or a prism shape with a partially spherical surface at the top, a cylindrical shape or a prism shape with a spire, or even an irregular shape.
  • the form shown in FIG. 1 is a cylindrical projection with a partially spherical top.
  • the tear passage 3 is creatively changed from an inner wall passage (or inner passage) to an outer wall passage (or outer passage) in common sense, and the protrusion 21 not only serves as a structure forming the outer passage of tears, but also serves as a
  • the lacrimal canaliculus embolism is stuck in the lacrimal canaliculus to fix the structure of the lacrimal canaliculus embolism. Due to the consideration of human comfort, elastic materials are preferred for lacrimal canaliculi.
  • lacrimal canaliculus embolism consists of the outer part of the protrusion 21 and the inner wall of the lacrimal canaliculus 4 (not shown in the figure).
  • the protruding portion 21 is in contact with the inner wall 4 of the lacrimal canaliculus (not shown in the figure) in a small area, which is beneficial to the flow of bacteria, proteins and other substances with the tear fluid and reduce the risk of inflammation.
  • the lacrimal duct embolism in this embodiment can be implanted in the lacrimal duct (lacrimal duct).
  • the protruding portion 21 is a left-handed thread or a right-handed thread surrounding the body
  • the outer tear fluid channel 3 is formed by a left-handed thread surface or a right-handed thread.
  • the threaded surface is formed outside a part of the body 2.
  • the form shown in Figures 2-4 is a right-handed thread. It can be understood that the same applies to the left-hand thread.
  • the surface of the thread and a part of the outer wall of the body 2 together form the wall of the outer tear fluid channel 3. This solution is supported by the outer part of the thread on the inner wall 4 of the lacrimal canaliculus, which has good supportability, and the thread processing is also very convenient. Meet the requirements of different degrees of lacrimal duct embolism.
  • changing the thread width of the left-handed thread or the right-handed thread of the body 2 can adjust the tear flow rate.
  • the tear fluid outflow rate is adjusted by adjusting the width of the thread to meet the requirements of different degrees of lacrimal ductal embolism.
  • changing the pitch of the left-handed thread or the right-handed thread of the body 2 can adjust the tear flow rate.
  • adjusting the pitch of the thread in the case of a constant internal and external diameter of the thread, adjusting the pitch is also equivalent to adjusting the helix angle) to adjust the flow rate of tear fluid to meet the requirements of different degrees of lacrimal ductal embolism.
  • a lacrimal canaliculus embolization includes: a body 2 extending along the axial direction of the lacrimal canaliculus; the outer side wall of the body 2 has a lacrimal canalicular tube wall 4 (in the figure)
  • the protrusion 21 extends in a direction not shown), and the surface of the protrusion 21 and at least a part of the outer wall of the body 2 form a tear duct 3 (not shown).
  • the protruding portion 21 is a boss 5, and the boss 5 protrudes from the body 2 in the radial direction, and at least one of the bosses 5 is formed.
  • a groove 6 is formed on the outer peripheral wall of each boss 5, and the groove wall and at least a part of the body 2.
  • the outer wall forms a tear fluid channel 3.
  • the tear fluid outflow rate can be adjusted by changing the number of the projections 5, the opening angle of the groove 6, the opening depth of the groove 6, and the number of the groove 6, so as to meet the requirements of different degrees of lacrimal ductal embolism.
  • the boss 5 is one, or two or more axially spaced apart.
  • the stability of the lacrimal canaliculus embolus placed in the lacrimal canaliculus can be adjusted by changing the number of the projections 5, two or more are more stable.
  • each boss 5 has 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.
  • the amount of tear fluid is adjusted by adjusting the number of the grooves 6 to meet different requirements of the degree of tear duct embolism.
  • the grooves 6 are evenly distributed along the circumferential direction of the body. In these embodiments, it is convenient to uniformly process the grooves 6 in the circumferential direction.
  • the grooves 6 of two adjacent bosses 5 are oppositely disposed or offset.
  • the opposite setting means that the grooves 6 of the different bosses 5 on the upper and lower sides are all opened at the same position;
  • the misalignment setting means that the grooves 6 of the different bosses 5 on the upper and lower sides have different starting positions and are offset from each other.
  • the relative or misalignment of the grooves 6 is used to adjust the tear flow direction and change the degree of energy loss during the tear flow, so that the tear flow speed can be adjusted to meet the purpose of convenient control of tear flow.
  • the misplaced slot 6 tear flow rate is generally slower than the relative setting.
  • the specific shape of the boss is not limited, and may be a sheet shape, a hemispherical shape, a cylindrical or prismatic shape, or even an irregular shape.
  • the form of the bosses shown in Figs. 6, 7, 8, 9 and 13 is taken as a sheet.
  • This multi-notch or multi-tear fluid channel design can more effectively avoid possible lacrimal duct obstruction and possible (caused by lacrimal duct obstruction) inflammation compared with the traditional hollow tubular lacrimal duct pathway design. reaction.
  • a lacrimal canaliculus embolization includes: a body 2 extending along the axial direction of the lacrimal canaliculus; the outer side wall of the body 2 has a lacrimal canaliculus tube wall 4 (Not shown in the figure) the protruding portion 21 extending in the direction, the surface of the protruding portion 21 and at least a part of the outer wall of the body 2 form a tear fluid channel 3 (shown in FIG. 11).
  • the protruding portion 21 is a protruding strip 7.
  • the protruding strip 7 is protruded from the body 2 in the radial direction, and the protruding strips 7 are continuously arranged along the body 2 from top to bottom.
  • the protruding strips 7 are one, or two and Two or more of them are arranged at intervals along the circumferential direction of the main body.
  • each protruding strip 7 penetrates the body 2 up and down, and if there is one protruding strip 7, a tear fluid channel is formed on both sides of the protruding strip 7. If there are two or more protruding strips 7, an external tear fluid channel 3 is formed between two adjacent protruding strips 7. Three or more protruding strips 7 are more stable.
  • the contact point of the protruding strip 7 with the lacrimal canaliculus is a sharp corner or an arc or a plane.
  • the contact portion between the protrusion 21 and the lacrimal canaliculus is a sharp angle (as shown in FIG. 5) or an arc (as shown in FIG. 12) or a plane (as shown in FIG. 5). 16).
  • the sharp-angled solution makes the lacrimal cannula embolization more securely placed in the lacrimal canaliculus, and the rounded-angle solution makes the lacrimal cannula embolization more comfortable in the lacrimal canaliculus, and the plane can take both firmness and comfort into consideration.
  • the contact point between the boss 5 and the lacrimal canaliculus is a sharp angle (as shown in FIG. 5) or an arc (as shown in FIG. 13).
  • the structure where the boss 5 contacts the lacrimal canaliculus can also be flat.
  • a lacrimal canaliculus embolism includes: a body 2 that extends along the axial direction of the lacrimal canaliculus; the outer side wall of the body 2 has a lacrimal canalicular tube wall 4 (not shown in the figure). (Shown), a protrusion extending in the direction, and the surface of the protrusion and at least a part of the outer wall of the body 2 form a tear fluid channel 3.
  • the protruding portion is a protruding strip 7.
  • the protruding strip 7 protrudes from the main body 2 in a radial direction thereof, and the protruding strips 7 are continuously arranged along the main body 2 from top to bottom.
  • the protruding strips 7 are deflected along the outer surface of the main body 2 by a certain angle from the top to the bottom (either left or right).
  • One protruding bar 7 or two or more protruding bars 7 are arranged at intervals along the circumferential direction of the body 2.
  • each protruding strip 7 penetrates the body 2 up and down, and if there is one protruding strip 7, a tear fluid channel is formed on both sides of the protruding strip 7. If there are two or more protruding strips 7, an external tear fluid channel 3 is formed between two adjacent protruding strips 7. Three or more protruding strips 7 are more stable.
  • FIG. 14 uses four protruding strips 7 as an example.
  • the protruding strip 7 contacts the lacrimal canaliculus with sharp corners or arcs or planes.
  • FIG. 14 shows a rounded form. It can be understood that the same applies to sharp corners and planes.
  • the lacrimal canaliculus embolization is in interference fit with the lacrimal canaliculus.
  • the lacrimal canaliculus embolism cooperates with the lacrimal canaliculus interference, and the lacrimal canalicula is not easy to slip out of the lacrimal canaliculus, ensuring long-term use.
  • this multiple tear fluid external channel design can more effectively avoid possible lacrimal duct obstruction and possible (caused by obstructed lacrimal duct) inflammatory response.
  • a lacrimal canaliculus embolization includes: a body 2 that extends along the axial direction of the lacrimal canaliculus.
  • the outer wall of the body 2 has a protruding portion 21 extending in the direction of the lacrimal canaliculus tube wall 4.
  • the surface of the protruding portion 21 and at least a part of the outer wall of the body 2 form an external tear passage 3 and a hollow internal tear passage located inside the body 2.
  • the interior of the body 2 may be a hollow tear fluid channel 8.
  • the point where the protrusion 21 contacts the wall of the lacrimal canaliculus is a sharp angle.
  • the contact area may be an arc or a plane.
  • the length of the lacrimal canaliculus embolism is 0.5 mm to 3.0 mm; the diameter of the outer edge of the lacrimal canaliculus embolism is 0.2 mm to 2.0 mm.
  • the width of the external lacrimal passage depends on the difference between the outer diameter of the lacrimal canaliculus embolus and the body diameter. Changing the width of the outer channel can adjust the speed of tear fluid outflow.
  • the lacrimal canaliculus embolization uses a polyisobutylene-based elastic material.
  • Lacrimal canaliculus embolism based on polyisobutylene elastic material can reduce foreign body sensation and discomfort.
  • the lacrimal canaliculus embolism is preferably made of a linear triblock copolymer material based on polyisobutylene (PIB) blocks.
  • PIB polyisobutylene
  • Its molecular structure is characterized by: glassy or crystalline (i.e., glass transition temperature or melting point higher than human body temperature) thermoplastic polymer blocks at both ends, while the central block is rubbery (i.e., glass transition temperature or melting point is lower than human body) Temperature) polyisobutylene polymer.
  • SIBS that is, poly (styrene-block-isobutylene-block-styrene)
  • Lacrimal canaliculus embolism is made by SIBS alone or by melt blending with nano silver particles.
  • SIBS is a linear triblock copolymer with polyisobutylene (PIB) as the middle block.
  • PIB polyisobutylene
  • SIBS has excellent biological stability, biocompatibility, mechanical elasticity, and processability. Due to thermodynamic incompatibility and triblock polymer molecular structure characteristics, polystyrene (PS) and polyisobutylene (PIB) self-aggregate to form an ordered microstructure.
  • PS polystyrene
  • PIB polyisobutylene
  • the high glass temperature (> body temperature, T b ) polystyrene hard segment (hard) micro-regions provide low-temperature glass ( ⁇ body temperature, T b ) amorphous polyisobutylene soft segment (soft) micro regions to provide physical interaction
  • T b body temperature
  • the mechanical properties such as the elastic modulus, hardness, and elongation required by the material can be achieved through molecular design through living cationic polymerization. Specific methods include adjusting the overall molecular weight, the block length of polystyrene (PS) and polyisobutylene (PIB), and the block length ratio (S / IB).
  • the triblock copolymer presents a molecular structure characteristic of "hard --- soft --- hard”.
  • the flexibility of the material is matched to the tissue of the implantation site, thereby reducing the allogeneic reaction caused by the high hardness of the implanted device.
  • the SIBS structural component has excellent biocompatibility and biological stability, it can avoid (due to long-term implantation) the tissue inflammatory response caused by the degradation of small molecular substances released by the material.
  • Nano silver particles are a broad-spectrum antibacterial ingredient. The dispersed nano-silver particles not only have antibacterial and anti-inflammatory effects, but also help to overcome the problem of difficult to locate and detect the tear duct embolism made of polymer materials.
  • Melt blending of SIBS and nano-silver particles can combine the advantages of the two materials in order to avoid problems with foreign body sensations and foreign body reactions caused by the mismatch (or excessive hardness) of the material's mechanical compliance (or hardness), and X-ray, CT, nuclear magnetic resonance and other materials used for medical detection are easy to locate and detect, which is convenient for subsequent medical treatment.

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Abstract

一种泪小管栓塞，包括：本体(2)，其沿泪小管的轴线方向延展；本体(2)的外侧壁具有向泪小管管壁(4)方向延伸的凸出部(21)，凸出部(21)表面与至少一部分本体(2)外壁，以及泪小管管壁(4)形成泪液外通道(3)。泪液通道由一般传统的内通道变为外通道，凸出部(21)不仅作为形成泪液外通道(3)的结构亦作为将泪小管栓塞卡在泪小管中以固定泪小管栓塞的结构。泪小管栓塞优先采用具有优异生物相容性、生物稳定性的SIBS弹性体材料单独，或与纳米银粒子熔融共混的工艺方法制备。泪小管栓塞产品，结构简单，定位可靠、稳定，大大降低异体反应和组织炎症的发生几率。

Description

一种泪小管栓塞 技术领域
本公开涉及医疗器械领域，尤其涉及一种泪小管栓塞。
背景技术
干眼症，又称干眼、角结膜干燥症(Kersto conjunctivitis sicca,KCS)，是一种由于全身或局部原因引起泪液功能障碍而导致的以角结膜干燥症状为主的一种常见的疾病。全球发病率很高，发病原因不完全清楚。但任何导致泪液生成和排出平衡失调及泪膜功能障碍均可引起干眼症。最常见的有系统性眼干燥综合征、屈光性角膜手术、眼前节烧伤、电脑辐射等。伴随着信息时代的到来，移动互联网的普及，人们接触电脑、手机的时间越来越长，干眼症也呈现逐年增加和低龄化的趋势。
干眼症是目前眼科临床的常见病与多发病。尤其是长期干眼患者，经常出现干燥、红眼、发痒、灼热、异物感、刺痛、流泪、畏光、视力下降、眼睛疲倦等症状，给患者带来极大的痛苦。重度干眼症将导致一系列的眼表疾病，如：角膜上皮缺损、结膜或角膜上皮变性、无菌性角膜溃疡、感染性角膜溃疡等。
目前轻度干眼症患者的治疗以保守治疗为主，保守治疗包括泪液代用品、促进泪液分泌和保存泪液等方法，如：1)人工泪液可通过湿润、润滑及营养角结膜，起到类似天然泪液的作用；2)利用药物(环孢霉素A，糖皮质激素，雄激素类固醇，溴苄环己胺，等)调节免疫功能促进泪腺组织及唾液腺组织分泌。
然而对中、重度干眼症患者，长期使用人工泪液后症状仍得不到缓解，则采用泪道阻塞的方法：即将细小的实心或管状栓塞放入泪小管内，截住泪液流向鼻泪管，使有限泪液在眼结膜囊中存留时间延长，一方面增加眼睛泪液的储 留，使自然泪液湿润角膜、结膜表面改善角膜表面，提供持久的滋润和保护作用，另一方面自然泪液富含免疫球蛋白和离子成分，维持电解质平衡，增加眼表防御能力。同时反作用于泪腺、结膜杯状细胞，促进泪液分泌及增加杯状细胞存活，增加泪膜的稳定性，同时提高了眼表面的抵抗外界微生物的能力。通过治疗，减轻和缓解了患者眼干症状，使角膜表面平滑，有利于泪膜功能恢复以促进角膜上皮修复。由于此方法操作简单、方便灵活，越来越普遍应用于临床治疗中、重度干眼症病患者。
临床使用的泪小管栓塞通常分为降解型和永久型(非降解型)，而针对中、重度干眼症患者主要采用永久型的泪小管栓塞。
目前，永久型泪小管栓塞多采用硅胶材料。硅胶材料具有良好的生物相容性和生物稳定性，机械弹性好，且易于加工。但是，硅胶材料的制备过程中会有硅石(Silica)，寡聚物(Oligomer)，以及环装单体(cyclic monomer)，这些杂质的长期存在会引起眼部异体反应(foreign body reaction)。
近年来，在永久型泪小管栓塞的制备中逐渐转向寻找采用其它新材料，大有取代传统有机硅材料的趋势。其中，美国Medennium公司采用具有热记忆功能的聚丙烯酸脂类共聚物，发明了智能永久型泪小管栓塞SmartPlug @，以及美国
Figure PCTCN2019095509-appb-000001
公司采用非降解型水凝胶发明了泪小管栓塞Form Fit Plug @。以上两种泪小管栓塞均为封闭型的泪小管栓塞。然而，泪道的完全阻塞将导致泪液无法对栓塞以下的泪小管、泪囊和鼻泪道进行浸润和冲洗。由于泪液中的抗菌成分无法抵达这些部位，大大增加了泪囊和泪鼻道炎症的发生几率，而且代谢后的泪水在栓塞上部泪小管的长期停留，会导致其中的微生物的大量繁殖，引发泪小管炎。
发明内容
本公开的目的是提供一种泪小管栓塞，使得泪液排出速度相对可控且避免 栓塞的滑脱，以满足缓解不同干眼症症状程度患者的长期需求。
本公开提供的技术方案如下：
一种泪小管栓塞，包括：
本体，所述本体沿泪小管的轴线方向延展；
所述本体的外侧壁具有向泪小管管壁方向延伸的凸出部，所述凸出部表面与至少一部分所述本体外壁形成泪液外通道。
本技术方案中，创造性地将泪液通道由一般常识中的内壁通道(或称“内通道”)变为外壁通道(或称“外通道”)，凸出部不仅作为形成泪液外通道的结构亦作为将泪小管栓塞卡在泪小管中以固定泪小管栓塞的结构。由于考虑人体舒适度，泪小管制造材料选用具有优异生物相容性和生物稳定性的聚异丁烯类弹性体材料。相比传统中空管状和实心柱状泪小管栓塞，本技术方案中的泪小管栓塞仅由凸出部的外侧部分(包括外缘)与泪小管壁接触，并采用舒适度更高的聚异丁烯类弹性体材料，尽量的降低患者异物感和过敏反应，提高了使用体验。
优选地，所述凸出部为围绕所述本体的左旋螺纹或右旋螺纹，所述泪液外通道由左旋螺纹表面或右旋螺纹表面与一部分所述本体外壁形成。
本技术方案中，泪液外通道由围绕本体的左旋螺纹或右旋螺纹构成，以螺纹的表面和本体外壁的一部分共同构成泪液外通道的壁，该方案由螺纹外侧部分支撑在泪小管壁上，支撑性好，螺纹加工亦十分方便，以满足不同泪小管栓塞程度要求。
进一步优选地，改变所述本体的左旋螺纹或右旋螺纹的螺距可以调节泪液流速。
本技术方案中，通过调节螺纹的螺距(在螺纹内外直径一定的情况下，调整螺距亦相当于调整螺旋角)从而调节泪液的流出速率，从而满足不同干眼症症状程度患者的需求。
进一步优选地，改变所述本体的左旋螺纹或右旋螺纹的螺纹宽度(即螺纹内外直径之差的一半)可以调节泪液流速。
本技术方案中，通过调节螺纹的宽度从而调节泪液的流出速率，从而满足不同干眼症症状程度患者的需求。
进一步优选地，同时改变所述本体的左旋螺纹或右旋螺纹的螺距和螺纹宽度调节泪液流速，从而满足不同干眼症症状程度患者的需求。
不同于螺纹方案，本公开亦提供另一优选方案，
所述凸出部为凸台，所述凸台由本体沿其径向方向凸出，所述凸台至少为一个；
每一个所述凸台的外周壁开有槽，所述槽壁与至少一部分所述本体外壁形成所述泪液外通道。本技术方案中，可以通过改变凸台数量、槽的开口角度大小、槽的开口深度以及槽的数量从而调节泪液的流出速率，以满足不同泪小管栓塞程度要求。
进一步优选地，所述凸台为一个，或两个及以上轴向间隔布置。
本技术方案中，可以通过改变凸台的数量从而调节泪小管栓塞放置在泪小管中的稳定性，两个及以上更加稳定。
进一步优选地，每一个所述凸台开有至少一个所述槽，或两个及以上槽。
本技术方案中，通过调节槽的数量从而调节泪液的流出速率，以满足不同泪小管栓塞程度要求。
进一步优选地，当所述槽为两个以上时，所述槽沿所述本体周向均布。
本技术方案中，槽周向均布加工时较为方便。
进一步优选地，当所述凸台为两个以上时，相邻两个所述凸台的槽相对设置或错位设置。
本技术方案中，通过槽的相对设置或错位设置，以便调节泪液流向，改变泪液流动过程中的能量损失程度，以此可以调解泪液流出速度，满足泪液流出 方便控制的目的。
除了上述螺纹和凸台方案外，本公开还提供另一优选方案，所述凸出部为凸出条，所述凸出条由本体沿其径向方向凸出，所述凸出条以直上直下或偏转一定角度自上而上下沿所述本体连续布置；所述凸出条为一个，或两个及以上沿所述本体周向间隔布置。
本技术方案中，每根凸出条上下贯穿本体，若有一个凸出条，则在凸出条的两侧形成泪液外通道。若有两个及以上凸出条，则相邻两条凸出条之间形成泪液外通道。
进一步优选地，所述凸台的形状可以为片状、半球状、圆柱或棱柱状、甚至不规则形状等。
进一步优选地，所述凸出条的外形可以为片状、半球状、圆柱或棱柱状、甚至不规则形状等。
进一步优选地，左旋螺纹或右旋螺纹与所述泪小管接触处为尖角或圆弧或平面。
本技术方案中，螺纹与泪小管接触处的结构为尖角或圆弧或平面，尖角方案使得泪小管栓塞在泪小管中安置更牢固，圆角方案更使得泪小管栓塞在泪小管中安置更舒适。
与上一个技术方案类似，凸台与所述泪小管接触处为尖角或圆弧或平面。凸出条与所述泪小管接触处为尖角或圆弧或平面。
进一步优选地，所述泪小管栓塞与泪小管过盈配合。
本技术方案中，泪小管栓塞与泪小管过盈配合，泪小管栓塞不容易从泪小管中滑脱，保证了使用的长效性。
进一步优选地，所述泪小管栓塞长度为0.5mm～3.0mm；所述泪小管栓塞外缘直径范围为0.2mm～2.0mm。
本技术方案中，通过调节泪小管栓塞长度以及泪小管栓塞的外缘直径，可 以满足不同泪小管栓塞使用者的要求。
进一步优选地，所述本体内部为中空的泪液内通道。
本技术方案中，采用本体内部泪液内通道和泪液外通道结合的方式，扩大了泪液流速的可控范围和可操作性。凸出部起到固定栓塞在泪小管内，泪液外通道(即栓塞本体外部的通道)具有控制泪液流出速度的功能；泪液内通道(即栓塞本体内部的通道)主要起控制泪液流出速度的功能。本方案的目的在于一旦泪液外通道或泪液内通道发生堵塞以后，另外一个通道能继续发挥引流泪液的作用，从而在设计上延长泪小管栓塞的使用寿命。如果泪小管完全堵塞，则会增加此部位炎症副反应发生的几率。
进一步优选地，所述泪小管栓塞采用基于聚异丁烯热塑性弹性材料。
本技术方案中，由于采用新型的设计和材料，基于聚异丁烯的弹性泪小管栓塞能减少异物感和不适感。
进一步优选地，所述泪小管栓塞采用由基于聚异丁烯[polyisobutylene(PIB)]嵌段的嵌段共聚物材料制造，所述嵌段包括橡胶态聚异丁烯聚合物，和玻璃态或结晶态热塑性聚合物。
本技术方案中，聚异丁烯嵌段聚合物既具有橡胶的弹性，也具有塑料的熔融热加工性能，尤其是具有出色的生物相容性和生物稳定性(在人体内不引起异体反应，也不降解)。聚异丁烯材料嵌段聚合物的优异生物稳定性得益于橡胶态的聚异丁烯嵌段其特殊的饱和分子结构：不含双键、无长支链、无不对称碳原子。尤其是无不对称碳原子使聚异丁烯嵌段不存在可以脱氢的化学途径，而聚乙烯和聚丙烯材料由于脱氢在人体内有一定的降解或交联。
进一步优选地，所述泪小管栓塞由基于聚异丁烯[polyisobutylene(PIB)]嵌段的线性三嵌段共聚物材料制造，所述线性三嵌段共聚物为两端玻璃态或结晶态的热塑性聚合物嵌段，中心嵌段为橡胶态聚异丁烯聚合物。
进一步优选地，所述泪小管栓塞为线性三嵌段共聚物热塑性弹性体SIBS 单独，或与纳米银粒子进行熔融共混制造；所述SIBS为聚苯乙烯-b-聚异丁烯-b-聚苯乙烯[poly(styrene-block-isobutylene-block-styrene)]三嵌段聚合物。
本技术方案中，制备泪小管栓塞的材料优先选择为基于聚异丁烯[polyisobutylene(PIB)]嵌段的线性三嵌段共聚物，其结构特征为：两端玻璃态或结晶态(即玻璃化转变温度或熔点高于人体温度)热塑性聚合物嵌段，而中心嵌段为橡胶态(即玻璃化转变温度或熔点低于人体温度)聚异丁烯聚合物。此处优先采用SIBS(即为聚苯乙烯-b-聚异丁烯-b-聚苯乙烯[poly(styrene-block-isobutylene-block-styrene)])作为制备泪小管栓塞的材料。SIBS作为三嵌段共聚物热塑性弹性体具有优异的生物稳定性、生物相容性，机械弹性和加工性能。在人体体温状态下，高分子量的PIB是柔软的橡胶态弹性体材料；而与之相反，PS(聚苯乙烯)嵌段则是玻璃态的塑料。特殊的三嵌段【硬(PS)--软(PIB)--硬(PS)】分子结构使SIBS材料富有良好的机械弹性。并且通过调节聚苯乙烯和聚异丁烯的相对量，可以优化出软硬度适宜的SIBS弹性体材料。并且，与传统的有机硅材料相比，SIBS植入眼部后，临床上无明显的炎症和异体反应。
作为硬段的聚苯乙烯嵌段可以被其他玻璃态或结晶态聚合物所替代，只需后者无可降解的基团，或无可降解的会引起毒副作用的基团。此类聚合物除聚苯乙烯外，还包括聚α-甲基苯乙烯，聚甲基丙烯酸甲酯，聚甲基丙烯酸乙酯等乙烯基苯类和甲基丙烯酸酯类聚合物，或他们的混合物。
银粒子是一种广谱抗菌成分。分散的纳米银颗粒不仅具有抗菌、抗炎的作用，而且有助于克服聚合物材料制成的栓塞难以定位探测的问题。将SIBS和纳米银粒子熔融共混，能综合两种材料的优点，一方面避免由于材料的机械柔顺度(或硬度)不匹配(或硬度过高)导致的异物感和异体反应问题，另一方面由于银为金属材料，医疗探测使用的X射线、CT、核磁共振等均容易进行 定位和探测，为后续的医疗提供方便。
本公开提供的一种泪小管栓塞，能够带来以下至少一种有益效果：
1、本公开创造性的将泪液通道由一般常识中的内壁通道(或称内通道)变为外壁通道(或称外通道)，凸出部不仅作为形成泪液外通道的结构亦作为将泪小管栓塞卡在泪小管中以固定泪小管栓塞的结构。由于考虑人体舒适度和长期植入性，泪小管制造材料选择以SIBS为代表的基于聚异丁烯的热塑性弹性材料。相比传统中空管状和实心柱状泪小管栓塞，本技术方案中的泪小管栓塞仅由凸出部的外侧部分(包括外缘)与泪小管壁接触，尽量的降低患者异物感和过敏反应，提高了使用体验。本公开的泪液外通道的宽度取决于泪小管栓塞外径和本体直径之差。改变所述外通道的宽度可以调节泪液流出流速。
2、本公开的一些方案中采用多泪液外通道的设计，相较于传统单纯的中空管状泪液内通道设计，可以更有效地避免可能的泪道堵塞，以及可能(由泪道堵塞而导致)的炎症反应。此外，采用本体部外泪液外通道与泪液内通道相结合的方式，还可以进一步扩大泪液流速的可控范围和可操作性。
3、泪液外通道由围绕本体的左旋螺纹或右旋螺纹构成，以螺纹的表面和本体外壁的一部分共同构成泪液外通道的壁。通过改变螺纹的螺距和/或螺纹的宽度，已达到调节泪液流出速度，从而满足不同干眼症症状程度患者的需求。
4、泪液外通道亦可以由围绕本体的凸台构成，所述凸台由本体沿其径向方向凸出，每一个所述凸台的外周壁开有槽。通过槽的相对设置或错位设置，以便调节泪液流向，改变泪液流动过程中的能量损失程度，以此可以调节泪液流出速度，满足泪液流出方便控制的目的。
5、泪液外通道亦可以由围绕本体的凸出条构成，所述凸出条由本体沿其径向方向凸出。凸出条以直上直下或螺旋形自上而下贯穿本体，相邻两条凸出条之间的凹槽形成泪液外通道。由此而形成的多泪液外通道的设计，不但可以调节泪液的流出速度，而且可以降低可能的泪液堵塞的风险。
6、无论螺纹还是凸台、凸出条，其外侧部分都易于支撑在泪小管壁上，支撑性好，加工亦十分方便，以满足不同泪小管栓塞程度要求。
7、螺纹、凸台或凸出条与泪小管接触处的结构为尖角或圆弧或平面，尖角方案使得泪小管栓塞在泪小管中安置更牢固，圆弧方案更使得泪小管栓塞在泪小管中安置更舒适，平面可兼顾牢固和舒适性。
8、此公开创造性地将外壁通道(或称外通道)设计与具有优异生物相容性、生物稳定性的SIBS弹性体材料相结合，制备了新一代泪小管栓塞产品。其结构简单，定位可靠、稳定，大大降低异体反应和组织炎症的发生几率，具有广阔的市场前景，相当强的市场竞争力，以及良好的社会效益。
附图说明
下面将以明确易懂的方式，结合附图说明优选实施方式，对泪小管栓塞的上述特性、技术特征、优点及其实现方式予以进一步说明。
图1是本公开的一实施例泪小管栓塞结构示意图；
图2是本公开的另一实施例泪小管栓塞结构示意图；
图3是图2的俯视示意图；
图4是本公开的一种实施例泪小管栓塞应用于泪小管中的示意图；
图5是本公开的另一实施例泪小管栓塞结构示意图；
图6是本公开的另一实施例泪小管栓塞结构示意图；
图7是图6的一种俯视示意图；
图8是图6的另一种俯视示意图；
图9是图6的再一种俯视示意图；
图10是本公开的另一实施例泪小管栓塞结构示意图；
图11是图10的俯视示意图；
图12是本公开的另一实施例泪小管栓塞结构示意图；
图13是本公开的另一实施例泪小管栓塞结构示意图；
图14是本公开的另一实施例泪小管栓塞结构示意图；
图15是本公开的另一实施例泪小管栓塞结构示意图；
图16是图15的俯视示意图；
图17是SIBS的化学结构示意图。
附图标号说明：
2为本体，21为凸出部，3为泪液外通道，4为泪小管内壁，5为凸台，6为槽，7为凸出条，8为泪液内通道；d1为泪小管栓塞外径，d2：泪小管栓塞的本体直径，P为螺纹间距，L为泪小管栓塞长度，α为槽口夹角。
具体实施方式
为了更清楚地说明本公开实施例或现有技术中的技术方案，下面将对照附图说明本公开的具体实施方式。显而易见地，下面描述中的附图仅仅是本公开的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图，并获得其他的实施方式。
为使图面简洁，各图中只是示意性地表示出了与本公开相关的部分，它们并不代表其作为产品的实际结构。另外，以使图面简洁便于理解，在有些图中具有相同结构或功能的部件，仅示意性地绘示了其中的一个，或仅标出了其中的一个。在本文中，“一个”不仅表示“仅此一个”，也可以表示“多于一个”的情形。
在一实施例中，如图1所示。一种泪小管栓塞，包括：本体2，其沿泪小管的轴线方向延展；本体2的外侧壁具有向泪小管管壁4(图中未显示)方向延伸的凸出部21，凸出部21表面与至少一部分所述本体2外壁形成泪液外通道3。凸出部21的具体形状本实施例不作限制，可以是半球状、圆柱或棱柱状、 顶部具有部分球面的圆柱或棱柱状、具有尖顶的圆柱或棱柱状、甚至不规则形状等。图1中示出的形式为顶部具有部分球面的圆柱状凸出部。
本实施例中，创造性的将泪液通道3由一般常识中的内壁通道(或称内通道)变为外壁通道(或称外通道)，凸出部21不仅作为形成泪液外通道的结构亦作为将泪小管栓塞卡在泪小管中以固定泪小管栓塞的结构。由于考虑人体舒适度，泪小管制造材料首选弹性材料；此外，相比传统中空管状和实心柱状泪小管栓塞，泪小管栓塞仅由凸出部21的外侧部分与泪小管内壁4(图中未显示)接触，尽量的降低患者异物感和过敏反应，提高了使用体验；而且，传统的中空管状泪小管栓塞或者实心栓塞的全部侧壁几乎均与泪小管内壁紧密接触，致使细菌有可能积存在泪小管栓塞与泪小管内壁之间无法排出，引起发炎或不适。本公开中凸出部21与泪小管内壁4(图中未显示)为小面积接触，有利于细菌、蛋白质等物质随泪液流走，减轻发炎风险。
值得说明的是，本实施例的泪小管栓塞可以植入泪小管(泪道)中。
在另一实施例中，如图2-4所示，在上一实施例的基础上，凸出部21为围绕本体的左旋螺纹或右旋螺纹，泪液外通道3由左旋螺纹表面或右旋螺纹表面与一部分本体2外形成。图2-4中示出的形式为右旋螺纹。可以理解，左旋螺纹亦同理。本实施例中，以螺纹的表面和本体2外壁的一部分共同构成泪液外通道3的壁，该方案由螺纹外侧部分支撑在泪小管内壁4上，支撑性好，螺纹加工亦十分方便，以满足不同泪小管栓塞程度要求。
在另一实施例中，如图2所示，改变本体2的左旋螺纹或右旋螺纹的螺纹宽度(即螺纹内外直径之差的一半，(d1-d2)/2)可以调节泪液的流出速度。本实施例中，通过调节螺纹的宽度从而调节泪液的流出速率，以满足不同泪小管栓塞程度要求。
在另一实施例中，如图5所示，改变本体2的左旋螺纹或右旋螺纹的螺距可以调节泪液流速。本实施例中，通过调节螺纹的螺距(在螺纹内外直径一定 的情况下，调整螺距亦相当于调整螺旋角)从而调节泪液的流出速率，以满足不同泪小管栓塞程度要求。
在另一实施例中，如图6-7所示，一种泪小管栓塞，包括：本体2，其沿泪小管的轴线方向延展；本体2的外侧壁具有向泪小管管壁4(图中未显示)方向延伸的凸出部21，凸出部21表面与至少一部分所述本体2外壁形成泪液外通道3(图中未显示)。凸出部21为凸台5，凸台5由本体2沿其径向方向凸出，凸台5至少为一个；每一个凸台5的外周壁开有槽6，槽壁与至少一部分本体2外壁形成泪液外通道3。本实施例中，可以通过改变凸台5数量、槽6的开口角度大小、槽6的开口深度以及槽6的数量从而调节泪液的流出速率，以满足不同泪小管栓塞程度要求。凸台5为一个，或两个及以上轴向间隔布置。本实施例中，可以通过改变凸台5的数量从而调节泪小管栓塞放置在泪小管中的稳定性，两个及以上更加稳定。
如图7、8、9、13所示，每一个凸台5开有至少一个槽6，或两个及以上槽6。图7示出了开四个槽6，图8示出了开一个槽6，图9示出了开两个槽6。本实施例中，通过调节槽6的数量从而调节泪液的流出速率，以满足不同泪小管栓塞程度要求。
如图7、9、13所示，当槽6为两个以上时，槽6沿本体周向均布。这些实施例中，槽6周向均布加工时较为方便。
如图7、9、13所示，当凸台5为两个以上时，相邻两个凸台5的槽6相对设置或错位设置。相对设置是指上下不同凸台5的槽6均开设在相同位置；错位设置是指上下不同凸台5的槽6开始位置不同，互相错位。本实施例中，通过槽6的相对设置或错位设置，以便调节泪液流向，改变泪液流动过程中的能量损失程度，以此可以调解泪液流出速度，满足泪液流出方便控制的目的。错位设置的槽6泪液流动速度一般会比相对设置慢。
在本公开实施例中，所述凸台的具体形状不作限制，可以是片状、半球状、 圆柱或棱柱状、甚至不规则形状等。图6，7，8、9和13中所示出的凸台的形式以片状为例。
此种多槽口、或多泪液外通道的设计，相较于传统单纯的中空管状泪液内通道设计，可以更有效地避免可能的泪道堵塞，以及可能(由泪道堵塞而导致)的炎症反应。
在本公开的另一实施例中，如图10-11所示，一种泪小管栓塞，包括：本体2，其沿泪小管的轴线方向延展；本体2的外侧壁具有向泪小管管壁4(图中未显示)方向延伸的凸出部21，凸出部21表面与至少一部分所述本体2外壁形成泪液外通道3(图11中显示)。凸出部21为凸出条7，凸出条7由本体2沿其径向方向凸出，凸出条7自上而上下沿本体2连续布置；凸出条7为一个，或两个及两个以上沿本体2周向间隔布置。本实施例中，每根凸出条7上下贯穿本体2，若有一个凸出条7，则在凸出条7的两侧形成泪液外通道。若有两个及以上凸出条7，则相邻两条凸出条7之间形成泪液外通道3。凸出条7为3个或以上更为稳定。凸出条7与泪小管接触处为尖角或圆弧或平面。
图12和图13所示为凸出部21的螺纹和凸台5的边缘以圆弧形式出现。可以理解，尖角方案使得泪小管栓塞在泪小管中安置更牢固，圆角方案更使得泪小管栓塞在泪小管中安置更舒适，平面可兼顾牢固和舒适性。
在本公开的另一些实施例中，如图5、12、16所示，凸出部21与泪小管接触处为尖角(如图5)或圆弧(如图12)或平面(如图16)。尖角方案使得泪小管栓塞在泪小管中安置更牢固，圆角方案更使得泪小管栓塞在泪小管中安置更舒适，平面可兼顾牢固和舒适性。
在本公开的另一些实施例中，如图6和13所示，凸台5与泪小管接触处为尖角(如图5)或圆弧(如图13)。当然，凸台5与泪小管接触处的结构亦可为平面。
在本公开的另一实施例中，如图14，一种泪小管栓塞，包括：本体2，其 沿泪小管的轴线方向延展；本体2的外侧壁具有向泪小管管壁4(图中未显示)方向延伸的凸出部，凸出部表面与至少一部分所述本体2外壁形成泪液外通道3。凸出部为凸出条7，凸出条7由本体2沿其径向方向凸出，凸出条7自上而上下沿本体2连续布置。凸出条7自上而下沿本体2的外表面偏转一定角度(可以左偏也可以右偏)。凸出条7为一个，或两个及两个以上沿本体2周向间隔布置。本实施例中，每根凸出条7上下贯穿本体2，若有一个凸出条7，则在凸出条7的两侧形成泪液外通道。若有两个及以上凸出条7，则相邻两条凸出条7之间形成泪液外通道3。凸出条7为3个或以上更为稳定。图14以4个凸出条7为例。，凸出条7与泪小管接触处为尖角或圆弧或平面。图14示出圆角形式。可以理解，尖角、平面亦同理。在本公开的另一些实施例中，泪小管栓塞与泪小管过盈配合。泪小管栓塞与泪小管过盈配合，泪小管栓塞不容易从泪小管中滑脱，保证了使用的长效性。
此种多泪液外通道的设计，相较于传统单纯的中空管状泪液内通道设计，可以更有效地避免可能的泪道堵塞，以及可能(由泪道堵塞而导致)的炎症反应。
在本公开的另一实施例中，如图15、16所示，一种泪小管栓塞，包括：本体2，其沿泪小管的轴线方向延展。本体2的外侧壁具有向泪小管管壁4方向延伸的凸出部21，凸出部21表面与至少一部分所述本体2外壁形成泪液外通道3，以及位于本体2内部的中空的泪液内通道8。本实施例和其他实施例中本体2内部均可为中空的泪液内通道8。图15中，凸出部21与所述泪小管管壁接触处为尖角。接触处为圆弧或平面亦可。
在上述所有实施例中，图均为示意图，由于材料加工成型不可避免会形成一些过渡、尖角、圆角以及加工误差等等，均包括在本公开的范围内。
应当说明的是，上述实施例均可根据需要自由组合。以上所述仅是本公开的优选实施方式。并且应当指出，对于本技术领域的普通技术人员来说，在 不脱离本公开原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本公开的保护范围。
在本公开的实施例中，泪小管栓塞长度为0.5mm～3.0mm；泪小管栓塞外缘直径范围为0.2mm～2.0mm。通过调节泪小管栓塞长度，以及泪小管栓塞的外缘直径，可以满足不同泪小管栓塞使用者的要求。
在本公开的实施例中，泪液外通道的宽度取决于泪小管栓塞外径和本体直径之差。改变所述外通道的宽度可以调节泪液流出速度。
在本公开的实施例中，泪小管栓塞采用基于聚异丁烯弹性材料。基于聚异丁烯弹性材料的泪小管栓塞能减少异物感和不适感。
在本公开的实施例中，如图17所示，泪小管栓塞优先采用由基于聚异丁烯[polyisobutylene(PIB)]嵌段的线性三嵌段共聚物材料制造。其分子结构特征为：两端玻璃态或结晶态(即玻璃化转变温度或熔点高于人体温度)热塑性聚合物嵌段，而中心嵌段为橡胶态(即玻璃化转变温度或熔点低于人体温度)聚异丁烯聚合物。此处首选采用SIBS(即为聚苯乙烯-b-聚异丁烯-b-聚苯乙烯[poly(styrene-block-isobutylene-block-styrene)])作为制备泪小管栓塞的材料。泪小管栓塞为SIBS单独，或与纳米银粒子进行熔融共混制造。
SIBS是以聚异丁烯[polyisobutylene(PIB)]为中间嵌段的线性三嵌段共聚物。本实施例中，SIBS作为三嵌段共聚物具有优异的生物稳定性、生物相容性，机械弹性和加工性能。由于热力学的不相容性和三嵌段的聚合物分子结构特征，聚苯乙烯(PS)和聚异丁烯(PIB)自聚集形成有序的微观结构。高玻璃态温度(>体温，T b)的聚苯乙烯硬段(hard)微区为低玻璃态温度(<体温，T b)的非晶态聚异丁烯软段(soft)微区提供物理交联点，使整个材料在体温(T b)环境下表现为弹性体。材料所需的弹性模量、硬度、伸长率等机械性能可以通过活性阳离子聚合手段进行分子设计，而得以实现。具体的方法有：调节总体分子量的大小、聚苯乙烯(PS)和聚异丁烯(PIB)的嵌段长度、和嵌段长度比(S/IB) 等。三嵌段共聚物呈现“硬段(hard)---软段(soft)---硬段(hard)”的分子结构特征。通过分子设计，使材料的柔顺性与植入部位组织相匹配，从而降低由于植入器械硬度过高而导致的异体反应。并且由于SIBS结构成分具有优异的生物相容性和生物稳定性，从而避免了(由于长期植入)材料降解释放出的小分子物质所导致的组织炎症反应。纳米银粒子是一种广谱抗菌成分。分散的纳米银颗粒不仅具有抗菌、抗炎的作用，而且有助于克服聚合物材料制成的泪小管栓塞难以定位探测的问题。将SIBS和纳米银粒子熔融共混，能综合两种材料的优点，以期避免由于材料的机械柔顺度(或硬度)不匹配(或硬度过高)导致的异物感和异体反应问题，并且由于银为金属材料，医疗探测使用的X射线、CT、核磁共振等均容易进行定位和探测，为后续的医疗提供方便。

Claims (22)

  1. 一种泪小管栓塞，其特征在于，包括：
    本体，所述本体沿泪小管的轴线方向延展；
    所述本体的外侧壁具有向泪小管管壁方向延伸的凸出部，所述凸出部表面与至少一部分所述本体外壁形成泪液外通道。
  2. 根据权利要求1所述的泪小管栓塞，其特征在于：
    所述凸出部为围绕所述本体的左旋螺纹或右旋螺纹，所述泪液外通道由左旋螺纹或右旋螺纹与一部分所述本体外壁形成。
  3. 根据权利要求2所述的泪小管栓塞，其特征在于：
    改变所述左旋螺纹或右旋螺纹的螺距和/或螺纹宽度以调节泪液流速。
  4. 根据权利要求1所述的泪小管栓塞，其特征在于：
    所述凸出部为凸台，所述凸台由本体沿其径向方向凸出，所述凸台至少为一个；
    每一个所述凸台的外周壁开有槽，所述槽壁与至少一部分所述本体外壁形成所述泪液外通道。
  5. 根据权利要求4所述的泪小管栓塞，其特征在于：
    所述凸台为一个，或两个及以上轴向间隔布置。
  6. 根据权利要求5所述的泪小管栓塞，其特征在于：
    每一个所述凸台开有一个所述槽，或两个及以上槽。
  7. 根据权利要求6所述的泪小管栓塞，其特征在于：
    当所述槽为两个以上时，所述槽沿所述本体周向均布。
  8. 根据权利要求4所述的泪小管栓塞，其特征在于：
    当所述凸台为两个以上时，相邻两个所述凸台的槽相对设置或错位设置。
  9. 根据权利要求1所述的泪小管栓塞，其特征在于：
    所述凸出部为凸出条，所述凸出条由本体沿其径向方向凸出，所述凸出条以直上直下或偏转一定角度自上而上下沿所述本体连续布置；
    所述凸出条为一个，或两个及以上沿所述本体周向间隔布置。
  10. 根据权利要求4-8中任一项所述的泪小管栓塞，其特征在于：
    所述凸台的形状可以为片状、半球状、圆柱或棱柱状、甚至不规则形状等。
  11. 根据权利要求9中任一项所述的泪小管栓塞，其特征在于：
    所述凸出条的外形可以为片状、半球状、圆柱或棱柱状、甚至不规则形状等。
  12. 根据权利要求2或3所述的泪小管栓塞，其特征在于：
    所述左旋螺纹或右旋螺纹与所述泪小管接触处为尖角或圆弧或平面。
  13. 根据权利要求4-8中任一项所述的泪小管栓塞，其特征在于：
    所述凸台与所述泪小管接触处为尖角或圆弧或平面。
  14. 根据权利要求9中所述的泪小管栓塞，其特征在于：
    所述凸出条与所述泪小管接触处为尖角或圆弧或平面。
  15. 根据权利要求1所述的泪小管栓塞，其特征在于：
    所述泪小管栓塞与泪小管过盈配合。
  16. 根据权利要求1所述的泪小管栓塞，其特征在于：所述本体内部为中空的泪液内通道。泪液内通道与泪液外通道在设计上可以相结合。
  17. 根据权利要求1所述的泪小管栓塞，其特征在于：
    所述泪小管栓塞长度为0.5mm～3.0mm；
    所述泪小管栓塞外缘直径范围为0.2mm～2.0mm。
  18. 根据权利要求1所述的泪小管栓塞，其特征在于：
    所述泪小管栓塞采用基于聚异丁烯热塑性弹性材料。
  19. 根据权利要求1所述的泪小管栓塞，其特征在于：
    所述泪小管栓塞优先采用由基于聚异丁烯嵌段的嵌段共聚物材料制造，所述嵌段包括橡胶态聚异丁烯聚合物，和玻璃态或结晶态热塑性聚合物。
  20. 根据权利要求19所述的泪小管栓塞，其特征在于：
    所述泪小管栓塞由基于聚异丁烯嵌段的嵌段共聚物材料制造，所述嵌段共聚物端部为玻璃态或结晶态热塑性聚合物嵌段，中心嵌为橡胶态聚异丁烯聚合物。
  21. 根据权利要求20所述的泪小管栓塞，其特征在于：
    所述泪小管栓塞由基于聚异丁烯嵌段的线性三嵌段共聚物材料制造，所述线性三嵌段共聚物为两端玻璃态或结晶态的热塑性聚合物嵌段，中心嵌段为橡胶态聚异丁烯聚合物。
  22. 根据权利要求21所述的泪小管栓塞，其特征在于：
    所述泪小管栓塞为线性三嵌段共聚物热塑性弹性体SIBS单独，或与纳米银粒子进行熔融共混制造；所述SIBS为聚苯乙烯-b-聚异丁烯-b-聚苯乙烯，是以聚异丁烯为中间嵌段的线性三嵌段共聚物。
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