CN111265359B - Cross-linker, cross-linking system for posterior scleral treatment - Google Patents

Cross-linker, cross-linking system for posterior scleral treatment Download PDF

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CN111265359B
CN111265359B CN202010135764.7A CN202010135764A CN111265359B CN 111265359 B CN111265359 B CN 111265359B CN 202010135764 A CN202010135764 A CN 202010135764A CN 111265359 B CN111265359 B CN 111265359B
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CN111265359A (en
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许寅聪
陈达
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0601Apparatus for use inside the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/062Photodynamic therapy, i.e. excitation of an agent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0635Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643Applicators, probes irradiating specific body areas in close proximity

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Abstract

The invention provides a cross-linking device and a cross-linking system for sclera treatment, wherein the cross-linking device comprises a main body part which is annular as a whole, a channel part which is cylindrical as a whole and a plano-convex lens, the main body part is provided with an annular shell, the main body part is made of opaque materials, the channel part is provided with a cylindrical shell, one end of the cylindrical shell is connected with the outer wall of the annular shell, the plano-convex lens is arranged in a hollow area of the annular shell, and the hollow area forms a treatment area for sclera treatment; the channel part is internally integrated with a light guide lighting channel, a drug feeding channel, a negative pressure self-cleaning channel and a negative pressure fixing channel. The cross-linker and the cross-linking system provided by the invention firstly provide a feasible scheme of posterior sclera collagen cross-linking, integrate the functions of drug administration, negative pressure suction fixation and self-cleaning while realizing illumination, and create a systemic device which is extremely applicable in clinic, so that the ultraviolet A-riboflavin cross-linking technology can be applied to the posterior sclera, and a new treatment means is provided for clinic.

Description

Cross-linker, cross-linking system for posterior scleral treatment
Technical Field
The present invention relates generally to the field of ophthalmic disease treatment devices, and more particularly to a cross-linker, cross-linking system for posterior scleral treatment.
Background
High myopia is also called pathological myopia and is a common blindness-causing eye disease, and various pathological changes such as retinal detachment, high myopia macular degeneration, retinal choroidal atrophy, posterior scleral staphyloma, paint cracks, Fuch's spots and the like can occur, so that the visual function is seriously damaged. China is one of the countries with the highest incidence rate of myopia in the world, the incidence rate is 70-90%, and meanwhile, the incidence rate of high myopia in China is very high, the investigation of middle school students in the western region of China in 2015 shows that the incidence rate of high myopia is (2.9 +/-0.4%), the investigation of middle school students above 17 years old reaches (9.9 +/-3.0%), and the statistics of university students in Shanghai in 2012 show that the incidence rate of high myopia reaches 19.5%. Serious complications occur in 61.7 percent of people with high myopia, and especially, 100 percent of people with high myopia have macular degeneration when the myopia degree is > -10.0D, so that the vision of patients is remarkably reduced until blindness, the quality of life of tens of millions of Chinese people is remarkably reduced, and a large amount of social resources are consumed.
The pathogenesis of the complications of high myopia is still not completely understood, and most scholars consider the relationship with genetic inheritance and acquired environmental factors, and regarding their possible pathological mechanisms, most scholars consider the most prominent pathological features to be ocular axis elongation and posterior scleral staphyloma. There is currently no satisfactory explanation for the mechanism of ocular axis elongation and posterior scleral staphyloma. The mechanical characteristics and defects of the scleral wall are considered to be one of important factors, because from the mechanical properties of the three-layer structure of the eyeball wall, the tangential moduli of the three are sequentially higher by one order of magnitude from the retina to the sclera under the same stress level, so that the sclera plays a key role in maintaining the shape of the eyeball.
There is no mature method for treating pathological myopia, most of patients with pathological myopia adopt corrective prescription by means of spectacle matching, LASIK operation and intraocular lens implantation with lens, but the problems that the axis of the eye is prolonged year by year, the degree of the eye is increased year by year and various complications are gradually caused cannot be fundamentally solved. The main mechanism of the reinforcement technology is to reinforce the weak sclera at the back of the eyeball of the pathological myopia eye through an implant, enhance the strength of the back sclera through inflammatory reaction, scar formation and the like, prevent the eye axis from further extending and finally achieve the purpose of preventing the visual function from further deteriorating. The operation has been for decades, and there are many reports at home and abroad, but the curative effect and the method of the operation are disputed 32429and even contradicted with each other. Meanwhile, various factors such as severe postoperative stimulation symptoms, insufficient sources of foreign sclera, uncertainty of curative effect duration and the like of some patients also restrict the application of posterior sclera reinforcement.
Therefore, the search for new methods for treating pathological myopia is urgent. Inspired by the application of the ultraviolet A-riboflavin corneal crosslinking technology in corneal diseases, the inventor explores the application of the ultraviolet A-riboflavin scleral crosslinking technology in pathological myopia through animal experiments and obtains better effect. The ultraviolet A-riboflavin sclera collagen crosslinking method is to crosslink collagen by using ultraviolet A and riboflavin, and covalent bonds are generated between adjacent procollagens of the sclera so as to enhance the biomechanical stability of the sclera. The principle of the method is that under the action of ultraviolet light A with the wavelength of 370nm or 465nm, riboflavin molecules are excited to a triplet state to generate an active oxygen group which mainly comprises singlet oxygen. The reactive oxygen species can react with various molecules to induce chemical crosslinking reactions (type ii photochemical reactions) between the amino groups of the collagen fibers, thereby increasing the mechanical strength of the collagen fibers and the ability to resist scleral expansion. In the previous subject, an ultraviolet A-riboflavin sclera collagen crosslinking experiment is carried out on a living defocused myopic animal model rabbit, 0.1% of riboflavin-5-phosphate is dripped into an exposed sclera for 5 minutes, then the exposed sclera is irradiated for 50 minutes by an ultraviolet lamp with the wavelength of 370nm and the power of 3.0mw/cm2, the elastic modulus of the sclera is increased by 33.43%, the creep rate is reduced by 53.17%, the limit stress is increased by 42.05%, the strength of the sclera is obviously improved, and the sclera collagen fiber cells are observed by measuring a full-field retinal amperogram and a 15000-time transmission electron microscope, so that no obvious toxic or side effect is found. Unfortunately, this method works with a uniform irradiation of uv light because the anatomical region is too deep to be exposed and cannot be achieved in the posterior segment of the sclera (retroscleral staphylomania occurs in the posterior segment), which greatly limits the feasibility of using uv a-riboflavin scleral crosslinking.
Although the prior art has made relevant studies on the above problems, certain technical achievements have been achieved.
For example, the prior chinese patent CN104758119B discloses a cross-linker for riboflavin-uv scleral cross-linking, which focuses only on the functions of light-guiding irradiation and no drug administration, and is clear and single in function.
The prior chinese patents CN104936563B (device for medical treatment of sclera) and CN106413644B (device for medical treatment of sclera) all relate to a cross-linking device of a certain structure, but the structural shape of the cross-linking device is not well matched with the posterior sclera, the structural size is large, the cross-linking device almost encloses the whole posterior sclera when in use, the cross-linking device cannot completely avoid the important structures of the posterior sclera, the actual anatomical structure indicates that the important structures of the posterior sclera are many, the important structures such as extraocular muscle and optic nerve must be avoided, meanwhile, the treatment is not targeted, the drug administration and the radiation treatment are not convenient for a certain treatment area, the design layout of the illumination, the drug administration and the drug recovery is not harmonious, the effects of the illumination, the drug administration and the drug recovery are not good, the operation can not be really fit with the clinical operation steps, especially, the cross-linking device does not have an automatic fixing structure and function, when in use, the device cannot be automatically fixed on the scleral wall of a treatment area, and the product use experience is poor.
Therefore, there is still a great need for improvement of the prior art, especially for application of a-riboflavin scleral collagen cross-linking, to solve the problem of treatment of pathological myopia such as posterior pole scleral enlargement.
Disclosure of Invention
In view of the defects of the prior art, the invention aims to design a brand-new system for posterior sclera crosslinking, integrates the functions of illumination, drug delivery, negative pressure self-cleaning and negative pressure suction fixing, meets the requirements of posterior sclera treatment, has small equipment volume, can be applied to the posterior sclera, and has great feasibility.
The technical scheme of the invention is as follows:
the invention provides a cross-linking device for posterior scleral treatment, which comprises a main body part which is annular as a whole, a channel part which is cylindrical as a whole and a plano-convex lens, wherein the main body part is provided with an annular shell, the main body part is made of opaque materials, the channel part is provided with a cylindrical shell, one end of the cylindrical shell is connected with the outer wall of the annular shell, the plano-convex lens is arranged in a hollow area of the annular shell, and the hollow area forms a treatment area for posterior scleral treatment; a plurality of independent channels are arranged in the channel part, wherein,
at least one channel is configured as a light-conducting illumination channel connecting the center of the plano-convex lens such that the light-conducting illumination channel is capable of directing illumination through the plano-convex lens to the treatment area;
the at least one channel is configured as a drug delivery channel, at least one radial drug delivery hole is formed in the inner wall of the annular shell, and the drug delivery hole is communicated with the drug delivery channel, so that the drug delivery channel can guide drugs to a treatment area;
the at least one channel is configured as a negative pressure self-cleaning channel, the inner wall of the annular shell is provided with at least one radial negative pressure suction hole, and the negative pressure suction hole is communicated with the negative pressure self-cleaning channel, so that redundant medicines and liquid in a treatment area can be sucked out by the negative pressure self-cleaning channel;
at least one channel is configured to be a negative pressure fixing channel, a plurality of axial negative pressure fixing holes are formed in the end face of the annular shell, and the negative pressure fixing holes are communicated with the negative pressure fixing channel, so that the negative pressure fixing channel can provide power through an external negative pressure system to enable the main body part to be fixedly adsorbed on the rear scleral wall of the treatment area.
In one embodiment of the present invention, a light guide fiber is installed in the light guide illumination channel, and one end of the light guide fiber contacts the center of the plano-convex lens.
In one embodiment of the invention, the annular shell further has a top cover, the light guide illumination channel is arranged in the cylindrical shell and the top cover, the bottom surface of the plano-convex lens is bonded and fixed on the inner surface of the top cover, and the light guide illumination channel penetrates out of the inner surface of the top cover and is connected with the plano-convex lens.
In one embodiment of the invention, the administration channel comprises an arc-shaped pipeline and a straight pipeline communicated with the arc-shaped pipeline at the midpoint of the arc-shaped pipeline, the straight pipeline is arranged in the cylindrical shell, the arc-shaped pipeline is arranged in the annular shell, the arc-shaped pipeline extends to 90 degrees from the connection point of the arc-shaped pipeline and the straight pipeline to the inside of the annular shells at two sides, and the inner walls of the annular shells at the two ends and the midpoint of the arc-shaped pipeline are respectively provided with one administration hole.
In one embodiment of the invention, the negative pressure self-cleaning channel comprises an arc-shaped pipeline and a straight pipeline communicated with one end of the arc-shaped pipeline, the straight pipeline is arranged in the cylindrical shell, the arc-shaped pipeline is arranged in the annular shell, the arc-shaped pipeline extends 180 degrees from the connection point of the arc-shaped pipeline and the straight pipeline into the annular shell at one side, and the inner walls of the annular shells at 135 degrees and 180 degrees on the arc-shaped pipeline are respectively provided with one negative pressure suction hole.
In one embodiment of the invention, the negative pressure fixing channel comprises an annular pipeline and a straight pipeline communicated with the annular pipeline, the straight pipeline is arranged in the cylindrical shell, the annular pipeline is arranged in the annular shell, and eight negative pressure fixing holes are correspondingly formed in the end face of the annular shell at every 45-degree interval on the annular pipeline.
In an embodiment of the present invention, the cross-linker further has a channel connection part, the front end of the channel connection part has a sleeve section, the sleeve section is used for connecting with the other end of the cylindrical shell, a light guide illumination fiber, a drug delivery pipeline, a negative pressure self-cleaning pipeline, and a negative pressure fixing pipeline are arranged in the sleeve section, and the light guide illumination fiber, the drug delivery pipeline, the negative pressure self-cleaning pipeline, and the negative pressure fixing pipeline correspond to the light guide illumination channel, the drug delivery channel, the negative pressure self-cleaning channel, and the negative pressure fixing channel in position one-to-one.
In one embodiment of the present invention, the passage connecting portion and the passage portion are of a separate structure or an integral structure.
In one embodiment of the present invention, the light guiding illumination channel, the drug delivery channel, the negative pressure self-cleaning channel, and the negative pressure fixing channel are sequentially disposed in the annular housing and the cylindrical housing from the top to the front end of the main body.
The invention also provides a cross-linking system for treating the posterior sclera, which comprises the cross-linker for treating the posterior sclera, and also comprises an illumination device, a positive pressure drug delivery system, a negative pressure self-cleaning system, a negative pressure fixing system and a controller which are externally connected, wherein the illumination device, the positive pressure drug delivery system, the negative pressure self-cleaning system and the negative pressure fixing system are connected with the channel part, the illumination device is used for irradiating light with corresponding wavelength and energy to a treatment area through the light guide illumination channel, the positive pressure drug delivery system is used for guiding drugs to the treatment area through the drug delivery channel, the negative pressure self-cleaning system is used for sucking out redundant drugs and liquid in the treatment area through the negative pressure self-cleaning channel, the negative pressure fixing system is used for adsorbing and fixing the cross-linker on the posterior scleral wall of the treatment area through the negative pressure fixing channel, and the controller, the illumination device, the negative pressure self-cleaning system and the negative pressure fixing system are connected with the channel part, and the controller, The positive pressure drug delivery system, the negative pressure self-cleaning system and the negative pressure fixing system are connected and used for carrying out parameter regulation and control on the illumination equipment, the positive pressure drug delivery system, the negative pressure self-cleaning system and the negative pressure fixing system.
Compared with the prior art, the invention has the beneficial effects that: the cross-linker and the cross-linking system provided by the invention firstly provide a feasible scheme of posterior sclera collagen cross-linking, integrate the functions of drug administration, negative pressure suction fixation and self-cleaning while realizing illumination, and create a systemic device with high clinical applicability, so that the ultraviolet A-riboflavin cross-linking technology can be applied to the posterior sclera, and a new treatment means is provided for clinic. And has at least the following specific practical effects:
(1) the cross-linking device with unique design has the structural appearance that the whole cross-linking device is in a magnifying glass shape by virtue of the annular main body part and the cylindrical channel part, the annular main body part is convenient to be attached to the rear sclera wall of a treatment area, and the actual operation of a user is facilitated;
(2) the skillfully designed drug delivery channel structure can distribute the drugs to the whole treatment area more quickly and uniformly during the operation on the premise of meeting the process feasibility of processing and manufacturing and the stability of the product;
(3) the negative pressure self-cleaning channel structure which is skillfully designed is beneficial to quickly removing redundant medicines and liquid, and avoids the influence of medicine leakage on non-treatment areas;
(4) the negative pressure fixing channel structure which is skillfully designed can ensure the reliability of adsorption of the cross-linker on the wall of the posterior scleral, and avoid moving in the operation process;
(5) the main body part which is integrally annular adopts opaque materials, so that the illumination is limited in the hollow area of the annular shell, and the influence on the periphery caused by the leakage in the process of ultraviolet treatment light irradiation can be avoided.
(6) The arrangement positions of the channels are designed skillfully, so that the optimal lighting effect, the optimal drug administration effect and the optimal self-cleaning effect can be provided;
(7) further set up the channel connection portion, built-in light guide fiber has solved the grafting unstability and the inaccuracy that temporarily inserted the light guide fiber existence during specific operation, satisfies the maneuverability of using.
(8) The use parameters can be regulated and controlled by a computer, and the requirements of diversity of use under different individuals and different conditions are met.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below. It should be apparent that the drawings in the following description are merely exemplary, and that other embodiments can be derived from the drawings provided by those of ordinary skill in the art without inventive effort.
The structures, ratios, sizes, and the like shown in the present specification are only used for matching with the contents disclosed in the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions that the present invention can be implemented, so that the present invention has no technical significance, and any structural modifications, changes in the ratio relationship, or adjustments of the sizes, without affecting the effects and the achievable by the present invention, should still fall within the range that the technical contents disclosed in the present invention can cover.
FIG. 1 is a side cross-sectional view of one embodiment of the cross-linker of the invention;
FIG. 2 is another cross-sectional side view of one embodiment of the cross-linker of the invention;
FIG. 3 is a top view of one embodiment of the cross-linker of the invention;
FIG. 4 is a front view of one embodiment of the cross-linker of the invention;
FIG. 5 is an exploded view of the internal structure of one embodiment of the cross-linker of the invention;
FIG. 6 is a perspective view of one embodiment of the cross-linker of the invention;
FIG. 7 is a schematic diagram in side perspective of one embodiment of the crosslinker of the invention;
FIG. 8 is a schematic exploded view of one embodiment of the cross-linker of the invention;
FIG. 9 is a schematic view of an assembled state of one embodiment of the cross-linker of the invention;
FIG. 10 is a schematic view of a cross-linker according to an embodiment of the invention in use.
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the principles of the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the embodiments of the present invention are described in further detail below with reference to the embodiments and the accompanying drawings. The exemplary embodiments and descriptions of the present invention are provided to explain the present invention, but not to limit the present invention.
In the description of the present invention, it is to be understood that the terms "comprises/comprising," "consists of … …," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a product, apparatus, process, or method that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such product, apparatus, process, or method if desired. Without further limitation, an element defined by the phrases "comprising/including … …," "consisting of … …," or "comprising" does not exclude the presence of other like elements in a product, device, process, or method that comprises the element.
It will be further understood that the terms "upper," "lower," "front," "rear," "left," "right," "top," "bottom," "inner," "outer," and the like, refer to orientations or positional relationships that are based on the orientation or positional relationship shown in the figures, and are used merely to facilitate description and to simplify description, rather than to indicate or imply that the device, component, or structure referred to must have a particular orientation, be constructed or operated in a particular orientation, and are not to be construed as limiting the invention.
Referring to fig. 1-4, an embodiment of the present invention firstly provides a cross-linking device for posterior scleral treatment, comprising an annular main body portion 6, an annular channel portion 7 and a plano-convex lens 2, wherein the main body portion has an annular housing 601, the main body portion is made of opaque material, the channel portion has a cylindrical housing 701, see fig. 1-3, and one end of the cylindrical housing is connected to the outer wall of the annular housing, so that the whole structure is in a magnifying glass shape, the plano-convex lens 2 is disposed in a hollow region 602 of the annular housing, and the hollow region forms a treatment region for posterior scleral treatment, see fig. 10; and a plurality of independent channels are arranged in the channel part, wherein,
at least one channel is configured as a light-conducting illumination channel 1, which connects the centers of the plano-convex lenses 2, such that the light-conducting illumination channel can guide illumination through the plano-convex lenses to the treatment area;
the at least one channel is configured as a drug delivery channel 3, the inner wall of the annular shell 601 is provided with at least one radial drug delivery hole 303, and the drug delivery hole is communicated with the drug delivery channel, so that the drug delivery channel can guide the drug to a treatment area;
at least one channel is configured as a negative pressure self-cleaning channel 4, the inner wall of the annular shell 601 is provided with at least one radial negative pressure suction hole 403, and the negative pressure suction hole is communicated with the negative pressure self-cleaning channel, so that the negative pressure self-cleaning channel can suck out redundant medicines and liquid in a treatment area;
at least one channel is configured as a negative pressure fixing channel 5, a plurality of axial negative pressure fixing holes 503 are formed in the end face of the annular shell 601, and the negative pressure fixing holes are communicated with the negative pressure fixing channel, so that the negative pressure fixing channel can provide power through an external negative pressure system to adsorb and fix the main body part on the rear scleral wall of the treatment area.
Through the design, the invention firstly provides a feasible scheme of posterior sclera collagen crosslinking, integrates the functions of drug administration, negative pressure suction fixation and self-cleaning while realizing illumination, creates systemic equipment which is extremely clinically applicable, enables the ultraviolet A-riboflavin crosslinking technology to be applied to the posterior sclera, and provides a new treatment means for clinic.
In one embodiment, a light guide fiber is installed in the light guide illumination channel 1, one end of the light guide fiber contacts the center of the planoconvex lens 2, and light guide illumination is realized by using the light guide fiber. The light guide fiber may be installed in the light guide illumination channel during the manufacturing of the device, or may be temporarily inserted into the light guide illumination channel during the use, as long as the light can be transmitted to the plano-convex lens.
It should be noted that the invention can also be designed such that the product itself is a luminous body, i.e. the light emitting end of the optical fiber is replaced by an LED lamp, the optical fiber is changed into a power supply line, and the power supply line supplies power to the LED lamp, thereby realizing the illumination of the treatment area.
In one embodiment, referring to fig. 3, the annular housing further has a top cover 603, the light-conducting illumination channel 1 is disposed within the cylindrical housing and the top cover, the bottom surface of the plano-convex lens 2 is adhesively secured to the inner surface of the top cover, and the light-conducting illumination channel passes out of the inner surface of the top cover to connect with the plano-convex lens.
In one embodiment, referring to fig. 1 and 5, the administration channel 3 comprises an arc-shaped pipe 302 and a straight pipe 301 communicated with the arc-shaped pipe at the midpoint of the arc-shaped pipe, the straight pipe is arranged in a cylindrical shell 701, the arc-shaped pipe is arranged in an annular shell 601, the arc-shaped pipe extends 90 degrees from the connection point of the arc-shaped pipe and the straight pipe into the annular shells at two sides, namely the connection point of the arc-shaped pipe and the straight pipe is taken as the starting point, namely the 0 degree position, the arc-shaped pipe extends to two sides for 90 degrees, and 1 administration hole 303 is opened to the hollow area perpendicular to the inner wall of the annular shell at the two end points and the midpoint of the arc-shaped pipe respectively. Through the design, excessive holes are avoided in the annular shell, the process feasibility of processing and manufacturing smaller parts and the stability of products can be met, and the medicines can be distributed to the whole treatment area more quickly and uniformly during operation.
In one embodiment, referring to fig. 1 and 5, the negative pressure self-cleaning channel 4 comprises an arc-shaped pipe 402 and a straight pipe 401 communicated with one end of the arc-shaped pipe, the straight pipe is arranged in the cylindrical shell, the arc-shaped pipe is arranged in the annular shell, the arc-shaped pipe extends 180 degrees from the connection point of the arc-shaped pipe and the straight pipe into the annular shell on one side, namely the connection point of the arc-shaped pipe and the straight pipe is taken as a starting point, namely the 0 degree position, extends 180 degrees to one side, and 1 negative pressure suction hole 403 is opened to the hollow area perpendicular to the inner wall of the annular shell at 135 degrees and 180 degrees respectively. According to the difference of left and right eyes to be treated, the arc-shaped pipeline is arranged on one corresponding side of the annular shell, the negative pressure suction holes 403 in the inner wall of the annular shell are correspondingly designed at 135 degrees and 180 degrees of the arc-shaped pipeline, and the two angles are at low points in practical operation, so that the rapid removal of redundant medicines and liquid by utilizing the action of gravity is facilitated, and the influence of medicine leakage on a non-treatment area is avoided.
In one embodiment, referring to fig. 1 and 5, the negative pressure fixing channel 5 includes an annular pipe 502 and a straight pipe 501 communicated with the annular pipe, the straight pipe is arranged in the cylindrical housing, the annular pipe is arranged in the annular housing, and eight negative pressure fixing holes 503 are formed in the annular pipe at every 45 ° interval, that is, eight negative pressure fixing holes are formed in the end face of the annular housing, and are perpendicular to the end face of the annular housing along the axial direction of the annular housing. So design, adsorb the cross-linker and fix on the scleral wall to the reliability of absorption can be ensured to eight absorption fixed orificess, avoids removing in the operation process.
As a preferred application, as shown in FIG. 1, the main body 6 of the present invention has a diameter of 5mm and a depth of 2.5mm, and is made of opaque plastic or medical stainless steel, which can prevent the leakage of UV rays during the irradiation process from possibly affecting the surroundings, and if it is made of plastic, it is coated with a light-shielding coating.
Further, the hollow area 602 of the annular housing 601 has a diameter of 4mm and a depth of 1.5 mm.
By adopting the size design, on the basis of meeting the process requirements and the practicability, the side effects of influencing peripheral important optic nerves and the like due to overlarge size can be avoided, the condition that the macular area, namely the surgical treatment area, cannot be completely covered due to too small size can be avoided, and the due effect of the surgery cannot be achieved.
Preferably, the length of the channel part is designed to be 5-10mm, the diameter of the channel part is designed to be 2-3mm, and the channel part is used as a handle of the cross-linking device for holding during use, so that the operation of a doctor is facilitated.
As a better application, the diameter of the light guide lighting channel is 0.5mm, the diameters of the dosing channel, the negative pressure self-cleaning channel and the negative pressure fixing channel are all 0.3mm, and the diameters of the corresponding dosing hole, the negative pressure suction hole and the negative pressure fixing hole are all 0.3 mm.
In one embodiment, referring to fig. 6 and 7, the light guide illumination channel 1, the drug delivery channel 3, the negative pressure self-cleaning channel 4, and the negative pressure fixing channel 5 are sequentially arranged in the annular housing and the cylindrical housing from the top to the front end of the main body part, so that the light guide illumination channel is uppermost in use, and a better illumination effect can be provided. Light guide illumination passageway below, at first the passageway of dosing through with the passageway setting of dosing at the high point, be favorable to utilizing the gravity of medicine self to distribute the medicine to whole treatment area more fast more even. The negative pressure self-cleaning channel is arranged below the administration channel and can quickly suck away redundant medicines and liquid flowing to the scleral wall from the upper part to the treatment area, so that the treatment area is kept clean, and the influence of medicine leakage on the non-treatment area is avoided. The foremost end of the main body part, namely the end surface of the main body part is a negative pressure fixing hole of the negative pressure fixing channel, so that the main body part is firmly adsorbed on the posterior scleral wall of the treatment area.
Referring to fig. 8 and 9, in another embodiment of the present invention, a channel connection portion 8 is further provided for the cross-linker, the front end of the channel connection portion has a sleeve section 9, the sleeve section is used for connecting with the other end of the cylindrical shell 701, a light guide illumination fiber 10, a drug delivery pipeline, a negative pressure self-cleaning pipeline, and a negative pressure fixing pipeline are arranged in the sleeve section, the light guide illumination fiber, the drug delivery pipeline, the negative pressure self-cleaning pipeline, and the negative pressure fixing pipeline correspond to the light guide illumination channel, the drug delivery channel, the negative pressure self-cleaning channel, and the negative pressure fixing channel in one-to-one correspondence, after the channel connection portion 8 is butted with the channel portion 7, the light guide illumination fiber 10, the drug delivery pipeline, the negative pressure self-cleaning pipeline, and the negative pressure fixing pipeline in the channel connection portion 8 can be respectively and accurately inserted into the light guide illumination channel, the drug delivery channel, the negative pressure self-cleaning channel, and the negative pressure fixing channel in the channel portion 7.
Preferably, the diameter of the channel connecting portion 8 is 2-3mm, the sleeve section can be connected with the cylindrical shell, the length of the channel connecting portion 8 is not limited specifically, as long as the channel connecting portion and the external device can be connected, the specific length can be flexibly set as required, for example, the specific length can be 5cm, 10cm or even 50-200cm, the material of the channel connecting portion 8 can be plastic, and the channel connecting portion 8 has certain elasticity and is convenient to be butted with the channel portion 7.
The channel connecting part and the channel part can be of a split structure, the channel connecting part and the channel part are assembled during processing and manufacturing, and the channel connecting part and the channel part can be used as a whole during operation. The two can also be an integral structure, a light guide lighting fiber, a drug delivery pipeline, a negative pressure self-cleaning pipeline and a negative pressure fixing pipeline are arranged in the two, and the two are formed as an integral structure during processing and manufacturing.
The rear end of the channel connecting part 8 is designed into a corresponding port according to actual conditions, and is connected with external equipment and a negative pressure system when in use.
The invention further provides a cross-linking system for posterior scleral treatment, which adopts the cross-linker for posterior scleral treatment, and further comprises an external illumination device, a positive pressure drug delivery system, a negative pressure self-cleaning system, a negative pressure fixing system and a controller, wherein the illumination device, the positive pressure drug delivery system, the negative pressure self-cleaning system and the negative pressure fixing system are connected with the channel part, the illumination device is used for irradiating light with corresponding wavelength and energy to a treatment area through a light guide illumination channel, the positive pressure drug delivery system is used for guiding drugs to the treatment area through the drug delivery channel, the negative pressure self-cleaning system is used for sucking out redundant drugs and liquid in the treatment area through the negative pressure self-cleaning channel, the negative pressure fixing system is used for adsorbing and fixing the cross-linker on the posterior scleral wall of the treatment area through the negative pressure fixing channel, and the controller and the illumination device, the positive pressure drug delivery system, the negative pressure fixing system and the controller, The negative pressure self-cleaning system is connected with the negative pressure fixing system and is used for carrying out parameter regulation and control on the illumination equipment, the positive pressure drug delivery system, the negative pressure self-cleaning system and the negative pressure fixing system.
In one embodiment, the designed wavelength of the illumination device is 370nm or 465nm, the external device can be replaced to change the wavelength according to the requirement, light rays with various wavelengths are introduced according to the requirement, the illumination intensity is 1mW/cm2-100mW/cm2, the illumination time is set according to the requirement, and the illumination time can be regulated and controlled by the controller.
The external positive pressure provided by the positive pressure drug delivery system is 10mmHg-100mmHg, and the external negative pressure provided by the negative pressure self-cleaning system and the negative pressure fixing system is 10mmHg-100mmHg, which can be regulated and controlled by a controller, and the controller can be pre-programmed by a computer.
The working principle of the invention is explained below with reference to the accompanying fig. 1-9 and with reference to fig. 10:
(1) opening an operation access: after anesthesia, the patient was cut on the temporal side 1/2 bulbar conjunctiva, the external rectus muscle was isolated, the inferior oblique muscle was isolated, and the posterior terminal end of the inferior oblique muscle was dissected.
(2) Placing a cross linker: the cross-linker is inserted under the external oblique muscle and pushed about 4mm towards the optic nerve, because 2.2mm behind the posterior end of the inferior oblique muscle is the macular region, i.e. the central position of pathological myopia with pathological lesion, and 5mm behind the posterior end of the inferior oblique muscle is the optic nerve, although it is generally more than 5mm in patients with pathological myopia, the pushing is designed to be about 4mm in order to avoid damaging the optic nerve in the treatment process. This both covers the macular area and ensures the safety of the treatment, which is why the optical illumination zone of the present invention has a diameter of 4 mm.
(3) Fixing the cross-linker: the negative pressure fixing channel is opened to carry out negative pressure suction and fixation on the equipment, the external negative pressure fixing system provides power to fix the cross-linking device at the corresponding position of the posterior scleral wall, the negative pressure exists all the time in the treatment process, the negative pressure provided by the connected negative pressure fixing system (negative pressure suction device) is regulated and controlled by a computer, and the negative pressure range is 10mmHg-100mmHg and can be regulated and controlled by the computer.
(4) Administration: the positive pressure drug delivery channel is opened to uniformly and continuously deliver riboflavin solution at a fixed speed, the external positive pressure drug delivery system provides power to push the drugs in the drug storage device to the inside of the main body part of the cross-linking device through the positive pressure drug delivery channel or through the positive pressure drug delivery pipeline and the positive pressure drug delivery channel of the channel connecting part, and finally the drugs flow into a hollow area below the annular shell of the main body part through the drug delivery hole to further play the role of drugs. Different concentrations are adopted according to the needs, and the medicine infiltration of tissues required to be treated locally is firstly carried out. The positive pressure range is 10mmHg-100mmHg, and can be controlled by computer.
(5) And (3) drug recovery: and opening a negative pressure self-cleaning channel, wherein negative pressure is provided by a negative pressure self-cleaning system (a negative pressure aspirator) connected with the negative pressure self-cleaning channel, the negative pressure self-cleaning system provides power to suck excessive riboflavin solution injected into the cross-linking device through the negative pressure self-cleaning channel or through a negative pressure self-cleaning pipeline and a negative pressure self-cleaning channel connected with the channel, so that interference of liquid medicine is prevented, and a hollow area is emptied after medicine is sucked, so that the light guide fiber can illuminate to excite cross-linking reaction. The negative pressure range is 10mmHg-100mmHg, and can be regulated and controlled by a computer.
(6) Opening an external illumination device: after the medicine infiltration of the tissues to be treated is finished after the medicine is administrated, the external illumination equipment is turned on, the light with corresponding wavelength and energy is irradiated to the required position through the light guide fiber, the wavelength depends on the external illumination equipment and is 370nm or 465nm, the external equipment can be replaced according to the requirement to change the wavelength, light rays with various wavelengths are introduced according to the requirement, the illumination intensity is 1mW/cm2-100mW/cm2, the illumination time is set according to the requirement, the steps (4) and (5) are periodically and circularly carried out in the cross-linking process to keep the treated position to be infiltrated by the riboflavin all the time without drying.
(7) And (5) stopping the negative pressure provided by the negative pressure fixing channel after the treatment is finished, taking out the cross-linking device, suturing the conjunctival wound, smearing the antibiotic eye ointment, bandaging the eye, and finishing the treatment.
It should be noted that the administration channel of the present invention may also administer other drugs than riboflavin, and is not limited to riboflavin.
Thus, it should be understood by those skilled in the art that while exemplary embodiments of the present invention have been illustrated and described in detail herein, many other variations and modifications can be made, which are consistent with the principles of the invention, from the disclosure herein, without departing from the spirit and scope of the invention. Accordingly, the scope of the invention should be understood and interpreted to cover all such other variations or modifications.

Claims (9)

1. The cross-linking device for posterior sclera treatment comprises a main body part which is annular as a whole, a channel part which is cylindrical as a whole and a planoconvex lens, wherein the main body part is provided with an annular shell, the main body part is made of opaque materials, the channel part is provided with a cylindrical shell, one end of the cylindrical shell is connected with the outer wall of the annular shell, the annular shell is provided with a top cover, the bottom surface of the planoconvex lens is fixedly bonded on the inner surface of the top cover so as to be arranged in a hollow area of the annular shell, and the hollow area forms a treatment area for posterior sclera treatment; a plurality of independent channels are arranged in the channel part, wherein,
at least one channel is configured as a light-conducting illumination channel connecting the centers of the plano-convex lenses such that the light-conducting illumination channel is capable of directing illumination through the plano-convex lenses to the treatment area;
the at least one channel is configured as a drug delivery channel, at least one radial drug delivery hole is formed in the inner wall of the annular shell, and the drug delivery hole is communicated with the drug delivery channel, so that the drug delivery channel can guide drugs to a treatment area;
the at least one channel is configured as a negative pressure self-cleaning channel, the inner wall of the annular shell is provided with at least one radial negative pressure suction hole, and the negative pressure suction hole is communicated with the negative pressure self-cleaning channel, so that redundant medicines and liquid in a treatment area can be sucked out by the negative pressure self-cleaning channel;
at least one channel is configured to be a negative pressure fixing channel, a plurality of axial negative pressure fixing holes are formed in the end face of the annular shell, and the negative pressure fixing holes are communicated with the negative pressure fixing channel, so that the negative pressure fixing channel can provide power through an external negative pressure system to enable the main body part to be fixed on the rear scleral wall of the treatment area in an adsorption mode;
the light guide lighting channel, the drug feeding channel, the negative pressure self-cleaning channel and the negative pressure fixing channel are sequentially arranged in the annular shell and the cylindrical shell from the top to the front end of the main body part.
2. The cross-linker for posterior scleral treatment of claim 1, wherein the light-conducting illumination channel has a light-conducting fiber mounted therein, one end of the light-conducting fiber contacting the center of the plano-convex lens.
3. The cross-linker for posterior scleral treatment of claim 2, wherein the light conducting illumination channel is disposed within the cylindrical housing and the cap, the light conducting illumination channel passing out of the inner surface of the cap to connect with the plano-convex lens.
4. The cross-linker for posterior scleral treatment according to claim 1, wherein the drug delivery channel comprises an arc-shaped tube and a straight tube communicating with the arc-shaped tube at a midpoint of the arc-shaped tube, the straight tube is disposed in the cylindrical housing, the arc-shaped tube is disposed in the annular housing, and the arc-shaped tube extends from its connection point with the straight tube into the annular housing at both sides for a total of 90 °, and the drug delivery holes are opened on the inner wall of the annular housing at both ends and the midpoint of the arc-shaped tube, respectively.
5. The cross-linking device for the posterior scleral treatment according to claim 1, wherein the negative pressure self-cleaning channel comprises an arc-shaped tube and a straight tube communicating with one end of the arc-shaped tube, the straight tube is disposed in the cylindrical housing, the arc-shaped tube is disposed in the annular housing, the arc-shaped tube extends 180 ° from the connection point of the arc-shaped tube and the straight tube into the annular housing on one side, and the negative pressure suction holes are respectively opened on the inner walls of the annular housing at 135 ° and 180 ° on the arc-shaped tube.
6. The cross-linking device for posterior scleral treatment according to claim 1, wherein the negative pressure fixing passage comprises an annular tube and a straight tube communicating with the annular tube, the straight tube is disposed in the cylindrical housing, the annular tube is disposed in the annular housing, and eight negative pressure fixing holes are correspondingly formed on the end surface of the annular housing at every 45 ° interval on the annular tube.
7. The cross-linker for posterior scleral treatment according to claim 1, further comprising a channel connection part, wherein the channel connection part has a sleeve section at the front end thereof, the sleeve section is used for connecting with the other end of the cylindrical shell, and a light-guiding illumination fiber, a drug delivery tube, a negative pressure self-cleaning tube, a negative pressure fixing tube are disposed in the sleeve section, and the light-guiding illumination fiber, the drug delivery tube, the negative pressure self-cleaning tube, the negative pressure fixing tube correspond to the light-guiding illumination channel, the drug delivery channel, the negative pressure self-cleaning tube, and the negative pressure fixing tube in one-to-one correspondence.
8. The cross-linker for posterior scleral treatment of claim 7, wherein the channel connection portion and the channel portion are of a split structure or a unitary integral structure.
9. A cross-linking system for posterior sclera therapy, comprising the cross-linker for posterior sclera therapy according to any one of claims 1 to 8, further comprising an external illumination device, a positive pressure drug administration system, a negative pressure self-cleaning system, a negative pressure fixing system and a controller, wherein the illumination device, the positive pressure drug administration system, the negative pressure self-cleaning system and the negative pressure fixing system are connected with the channel part, the illumination device is used for irradiating the light with corresponding wavelength and energy to the therapy region through the light-conducting illumination channel, the positive pressure drug administration system is used for guiding the drug to the therapy region through the drug administration channel, the negative pressure self-cleaning system is used for sucking out the redundant drug and liquid in the therapy region through the negative pressure self-cleaning channel, the negative pressure fixing system is used for fixing the cross-linker on the posterior scleral wall in the therapy region through the negative pressure fixing channel, the controller is connected with the illumination equipment, the positive pressure drug delivery system, the negative pressure self-cleaning system and the negative pressure fixing system and is used for carrying out parameter regulation and control on the illumination equipment, the positive pressure drug delivery system, the negative pressure self-cleaning system and the negative pressure fixing system.
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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1089127A (en) * 1992-11-20 1994-07-13 冈本新生郎 Operation of cornea method and device thereof
CN101175459A (en) * 2005-05-10 2008-05-07 片岡卓也 Ophthalmologic laser treatment instrument
CN104936563A (en) * 2012-10-08 2015-09-23 莱比锡大学 A device for a medical treatment of a sclera
CN108403292A (en) * 2018-03-29 2018-08-17 牟国营 A kind of sclera cross-linking apparatus and application method
CN109621224A (en) * 2019-02-13 2019-04-16 首都医科大学附属北京同仁医院 A kind of ophthalmically acceptable collagen cross-linking integration apparatus
CN212015936U (en) * 2020-03-02 2020-11-27 许寅聪 Cross-linker, cross-linking system for posterior scleral treatment

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1089127A (en) * 1992-11-20 1994-07-13 冈本新生郎 Operation of cornea method and device thereof
CN101175459A (en) * 2005-05-10 2008-05-07 片岡卓也 Ophthalmologic laser treatment instrument
CN104936563A (en) * 2012-10-08 2015-09-23 莱比锡大学 A device for a medical treatment of a sclera
CN108403292A (en) * 2018-03-29 2018-08-17 牟国营 A kind of sclera cross-linking apparatus and application method
CN109621224A (en) * 2019-02-13 2019-04-16 首都医科大学附属北京同仁医院 A kind of ophthalmically acceptable collagen cross-linking integration apparatus
CN212015936U (en) * 2020-03-02 2020-11-27 许寅聪 Cross-linker, cross-linking system for posterior scleral treatment

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