CN109199692B

CN109199692B - Auxiliary device for vitreous cavity injection

Info

Publication number: CN109199692B
Application number: CN201710553737.XA
Authority: CN
Inventors: 王大虎; 刘新泉; 单亚洲
Original assignee: Longhua Hospital Affiliated to Shanghai University of TCM
Current assignee: Longhua Hospital Affiliated to Shanghai University of TCM
Priority date: 2017-07-08
Filing date: 2017-07-08
Publication date: 2021-06-25
Anticipated expiration: 2037-07-08
Also published as: CN109199692A

Abstract

The invention discloses an auxiliary device for vitreous cavity injection, which consists of a fixing ring, an eyelid support and a support beam for connecting the fixing ring and the eyelid support. The size can be selected according to the size of the eyeball, the medicine can be safely and effectively injected into the vitreous cavity in an auxiliary way, the position and the depth of the medicine administration are relatively fixed, the use is convenient, the operation is simple, the operation risk can be reduced, the operation efficiency is improved, and the requirements of human engineering are met.

Description

Auxiliary device for vitreous cavity injection

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an auxiliary device for intravitreal injection administration (or intravitreal puncture drainage).

Background

At present, with the aging, the incidence of diseases in the posterior segment of the eye is increasing, and the diseases are also one of the main causes of vision loss. For example: epidemiological survey results show that age-related macular degeneration (AMD) is the leading cause of blindness in people over 50 years of age in western countries, and the incidence rate in Asia also tends to rise year by year; diabetic Retinopathy (DR) is the most important blinding eye disease in the working age population of developed countries, and 2 population-based epidemiological studies of the recent organization of the Beijing Hojingren eye center discover that the prevalence rate of DR in diabetes of Chinese adults is 27.9% -43.1%; central Retinal Vein Occlusion (CRVO) is a common retinal vascular disease, the prevalence rate of people is 0.7-1.6%, and the incidence rate of CRVO of middle-aged and elderly people is gradually increased along with the high incidence of metabolic diseases such as hyperlipidemia and diabetes in recent years, wherein blood deficiency type and vision prognosis are poor, and 40-80% of patients can develop neovascular glaucoma; others are as follows: polypoidal Choroidal Vasculopathy (PCV), Pathologic Myopia (PM) macular hemorrhage, retinopathy of prematurity (ROP), and the like. Currently, there are mainly 4 routes of administration in clinical use for treating retinal related diseases:

1. systemic administration: under the action of the inner and outer layers of blood-retina barriers, the amount of medicine absorbed into intraocular tissues such as vitreous body and retina is very small (the concentration of medicine entering vitreous body is usually less than 10% of that in blood plasma), the effective medicine concentration cannot be reached, the medicine concentration in intraocular retina tissue can be partially improved by increasing the administration dosage, but serious systemic toxic and side effects can also be caused.

2. Ocular administration (mainly eye drops): the conventional eye drops are difficult to achieve effective drug concentration in retinal tissues after being dropped into the eyes due to the rapid loss of the drug on the ocular surface, the aqueous humor barrier and the like.

3. Injection around the ball: compared with systemic administration and ocular surface administration, the administration of the drug by the route is easier to reach intraocular tissues and has smaller wound than intravitreal injection, but the curative effect of the drug is limited by the problem of how to transfer effective dose of the drug to tissues of posterior segments of eyes such as retina, choroid and the like to a great extent, repeated injection is required to maintain effective drug concentration, and the compliance of patients is poor.

4. Injecting in a vitreous cavity: intravitreal injection is one of the most widely used routes of administration in the treatment of retinal diseases, and has the advantages that the drug directly enters intraocular tissues, and the concentration of the drug in the tissues can reach a higher level, so that the immediate therapeutic effect is obtained. However, this method is invasive and is likely to cause complications such as short-term or transient ocular pressure elevation, endophthalmitis, bulbar conjunctival hemorrhage, vitreous hemorrhage, retinal detachment, cataract, and the like.

In summary, systemic administration, ocular surface administration and perisphere injection cannot be ideal administration schemes for treating posterior segment ocular diseases due to insufficient action intensity or more side effects, and although intravitreal injection administration schemes have potential risks and side effects, the intravitreal injection administration schemes have become main administration schemes for treating posterior segment ocular neovascular diseases (such as wAMD, DR, CRVO, PCV, and the like) due to significant curative effects (no alternative schemes with similar curative effects and less side effects are found clinically).

Finally, intravitreal injection of ranibizumab is exemplified: ranibizumab (trade name Lucentis) is a monoclonal antibody drug for resisting vascular endothelial growth factor, has been approved for intraocular application, and is widely used for treating intraocular neovascular diseases such as wAMD, DR, CRVO and the like. The ranibizumab belongs to a macromolecular monoclonal antibody biological preparation, and due to the physiological barrier effect of eyes, the ranibizumab cannot be effectively absorbed to tissues such as retina, choroid and the like to play a therapeutic role in conventional ocular administration, and only intravitreal injection is taken as a main administration mode at present. The method comprises the following steps: firstly, flushing the conjunctival sac with normal saline, advising the patient to lie on an operation bed, after the anesthesia of the surface of the operation eye (part of the patients can be anesthetized by a ball), taking effect, carrying out conventional disinfection by povidone iodine, laying an operation hole towel, sticking an eye pad, and spreading the eyelid by an eyelid opener; then, ordering the patient to watch on the nose or the lower part of the nose, inserting a needle at a position 3.5 or 4mm (measured by a ruler) behind the temporal superior or temporal inferior limbus of the operated eye, inserting a needle 5-7mm to the central position of an eyeball by using a 30G (outer diameter is about 0.31mm) or 33G (outer diameter is about 0.21mm) injection needle, then slowly injecting 0.05ml of medicine, pulling out the needle after the medicine is injected, and immediately pressing the needle eye by using a wet cotton swab for about 1min to prevent the medicine from flowing backwards; finally, the eye is coated with antibiotic eye ointment and gauze is used for sealing the eye.

However, when intravitreal injection is performed, it is necessary to insert a needle 3.5 or 4mm behind the limbus (here, pars plana where there is no retinal tissue and depending on the lens state of the eye being injected) to deliver the drug to the vitreous to avoid complications such as retinal tears and detachments, so each procedure requires accurate measurement with a ruler, which is time consuming and inefficient for inexperienced physicians. Secondly, the injection needle needs to be inserted into the central position of the eyeball, the adjacent tissues such as crystalline lens, retina and the like can be damaged by improper operation, and serious complications can be caused for inexperienced doctors. In addition, no unified standard exists at present for the position and the depth of intravitreal injection administration, and the operation is basically carried out by referring to the instruction manual of each product.

Disclosure of Invention

In view of the current situation of the current surgery, according to an embodiment of the present invention, it is desirable to provide an auxiliary device for intravitreal injection and drug delivery, which can select a suitable size according to the size of an eyeball, can assist in safe and effective injection of drugs into the vitreous cavity, has a relatively fixed drug delivery position and depth, is convenient to use and simple to operate, and can reduce surgical risks and improve surgical efficiency.

According to an embodiment, the present invention provides an auxiliary device for vitreous cavity injection, which can be adjusted to a suitable size according to the size of an eyeball, comprising a fixing ring, an eyelid support and a support beam, wherein:

the center of the fixing ring is hollowed out, the appearance of the fixing ring is similar to an ellipse, the fixing ring is provided with a front surface and a rear surface, an inner ring and an outer ring, the front surface and the rear surface are vertically symmetrical, the left surface and the right surface are asymmetrical, one side of the fixing ring is wide, and the other side of the; the wider side of the front surface of the fixing ring is provided with two convex cylindrical structures which are symmetrical up and down and correspond to the temporal side of the eyeball, each cylindrical structure is internally provided with 3 tube cavities, and each tube cavity is vertical to the surface of the eyeball; the rear surface of the fixing ring is a spherical surface with a hollow center, the spherical radius of the fixing ring is approximately equal to 1/2 eye axis, and the fixing ring is completely attached to the surface of an eyeball; the inner ring of the fixing ring is adjacent to the corneal limbus, the upper part and the lower part of the fixing ring are in a semicircular arc shape, and the left side and the right side of the fixing ring are respectively provided with a symmetrical radian defect;

the eyelid supports are arranged into an upper eyelid support and a lower eyelid support, which are symmetrically distributed and are composed of two baffles which are arranged in tandem and form a certain angle; an included angle is formed between the two front baffles; the rear baffle and the fixing ring are continuously and integrally formed, and the rear baffle is arranged between the eyeball and the eyelid and is attached to the eyeball;

the front surface of the auxiliary device is provided with two support beams which are symmetrical left and right, are convex and have radian and are close to the inner ring of the fixing ring to connect the fixing ring and the eyelid support.

The main thought of the design of the invention is as follows: the auxiliary vitreous cavity injection device consists of a fixing ring, an eyelid support and a support beam connecting the fixing ring and the eyelid support. In addition, scale marks are attached, and a ruler is not needed for measurement; the hole of the injection tube always points to the center of the eyeball, so that the worry of damaging adjacent tissues such as crystals, retina and the like is avoided; and has the function of an eyelid retractor, and is convenient to use. The material aspect can select safe and nontoxic materials with certain elasticity and good histocompatibility, such as silica gel, polypropylene and the like; the process aspect may use die forging or 3D printing. The following embodiments will specifically illustrate that the auxiliary device can assist in safely and effectively injecting the medicine into the vitreous cavity, the position and the depth of the medicine administration are relatively fixed, the use is convenient, the operation is simple, the surgical risk can be reduced, and the surgical efficiency can be improved.

Drawings

Fig. 1 is a front view schematically showing a vitreous cavity injection assisting device.

Fig. 2 is a schematic oblique view of the auxiliary device for intravitreal injection.

Fig. 3 is a schematic side view of the vitreous cavity injection aid.

Fig. 4 is a rear view schematically showing the vitreous cavity injection assisting device.

Fig. 5 is a top or bottom view of the vitreous cavity injection aid.

Wherein: 1 is a fixed ring; 2 is eyelid support; 3 is a supporting beam; 4 is a cylindrical structure; 5 is a tube cavity; 6 is radian defect.

Detailed Description

The invention is further illustrated with reference to the following figures and specific examples. These examples are to be construed as merely illustrative and not limitative of the remainder of the disclosure in any way whatsoever. After reading the description of the invention, one skilled in the art can make various changes and modifications to the invention, and such equivalent changes and modifications also fall into the scope of the invention defined by the claims.

The parameters of the auxiliary device for intravitreal injection according to the invention in the following examples are all referenced to the eyeball diameter of 24 mm.

As shown in fig. 1 to 5, the auxiliary device for vitreous cavity injection of the new design provided by the preferred embodiment of the present invention is composed of a fixing ring 1, an eyelid support 2 and a support beam 3 connecting the two, wherein:

the central part of the fixing ring 1 is hollow, the shape is similar to an ellipse, the fixing ring has a front surface and a back surface, an inner ring and an outer ring, the fixing ring is vertically symmetrical and is horizontally asymmetrical (one side is wide and the other side is narrow), the function of fixing eyeballs is achieved, certain elasticity is kept, and the fixing ring is convenient to fold. The wider side of the front surface of the fixing ring 1 is provided with two convex cylindrical structures 4 which are symmetrical up and down (arranged in a shape of '>' or '<', the openings face outwards, and the included angle is about 45 degrees), and the cylindrical structures are always kept corresponding to the temporal side of the eyeball (the cylindrical structures are placed in an up-down inverted mode to adapt to the difference of eyes); 3 tube cavities 5 are arranged in a straight line in each cylindrical structure 4, the distances from the cylindrical structures to the corneal limbus are respectively 3.0mm, 3.5mm and 4.0mm, and the cylindrical structures play the role of a ruler; moreover, each lumen 5 is thin (inner diameter is about 0.4mm) and has a certain height (about 5mm from the surface of the eyeball), so that the lumen has guiding and fixing functions on the injection needle and is vertical to the surface of the eyeball, thereby ensuring that the injection needle always points to the center of the eyeball, and thus ensuring that the position of the injection needle is relatively fixed to reduce disturbance to the vitreous body, thereby reducing surgical accidents. The rear surface of the fixing ring 1 is a spherical surface with a hollow center, the radius of the spherical surface is approximately equal to 1/2, the ocular axis is approximately equal to the eyeball radius, and the spherical surface is completely attached to the eyeball surface to limit the eyeball motion. The inner ring of the fixing ring 1 is similar to a cross shape, is adjacent to the corneal limbus, is in a semicircular arc shape from top to bottom, has symmetrical radian defects 6 (convenient for observing the corneal limbus) from left to right, and ensures that the vitreous cavity injection auxiliary device is always positioned in the center of an eyeball by adjusting the position of the arc defects.

The eyelid supports 2 have about two, and the symmetric distribution is formed by two baffles that are a certain angle (about 120 degrees) in tandem, and the contained angle of a slice of baffle (preceding baffle) in front of two is about 60 degrees, and wherein a slice of baffle (backplate) that is located behind is placed between eyeball and eyelid, and a slice of baffle (preceding baffle) in front then prevents that the eyelid is closed, has just so played the effect of eyelid retractor. In addition, the forefinger and the thumb are respectively arranged on the upper front baffle and the lower front baffle, and the fixing ring 1 can be folded by closing and pressing up and down with great force so as to be convenient for placing or taking out the eyeball surface. Two convex, bilaterally symmetrical and radian-shaped supporting beams 3 are arranged near the inner ring of the front surface, are connected with the fixing ring 1 and the eyelid support 2, and play a role in reinforcing the auxiliary device for vitreous cavity injection.

As shown in fig. 1, the auxiliary device for vitreous cavity injection comprises a fixing ring 1, an eyelid support 2 and a supporting beam 3 connecting the fixing ring and the eyelid support, wherein the fixing ring 1 is hollow in the center, has an elliptical shape, is symmetrical up and down, and is asymmetrical left and right (one side is wide and the other side is narrow); the thickness of the fixing ring 1 is 1.5mm, the width of the wider side of the fixing ring is 5mm, the width of the narrow side of the fixing ring is 3mm, the outer diameter of the fixing ring is 21.5mm, and the inner diameter of the fixing ring is 19.5 mm. The wider side of the front surface of the fixing ring 1 is provided with two convex cylindrical structures 4 which are symmetrical up and down (arranged in a shape of '>' or '<' >, the openings face outwards, and the included angle is about 45 degrees), and the two cylindrical structures correspond to the temporal side of the eyeball; each cylindrical structure 4 is internally provided with 3 tube cavities 5 which are arranged in a straight line, and the distances from the cylindrical structures to the corneal limbus are respectively 3.0mm, 3.5mm and 4.0 mm; furthermore, each lumen 5 is thin (about 0.4mm inner diameter) and has a certain height (about 5mm from the surface of the eyeball) and is maintained perpendicular to the surface of the eyeball. The inner ring of the fixing ring 1 is similar to a cross shape, is adjacent to the corneal limbus, is in a semicircular arc shape from top to bottom, and has symmetrical radian defects 6 from left to right. The eyelid supports 2 are symmetrically distributed with an upper part and a lower part. Two convex, bilateral symmetry, arc supporting beams 3 are arranged near the inner ring of the front surface, and are connected with a fixing ring 1 and an eyelid support 2.

As shown in fig. 2, the wider side of the front surface of the fixing ring 1 is provided with two convex cylindrical structures 4 (arranged in a ">" or "<" shape, with the opening facing outwards and an included angle of about 45 °) which are symmetrical up and down and correspond to the temporal side of the eyeball; each cylindrical structure 4 is internally provided with 3 tube cavities 5 which are arranged in a straight line, and the distances from the cylindrical structures to the corneal limbus are respectively 3.0mm, 3.5mm and 4.0 mm; furthermore, each lumen 5 is thin (about 0.4mm inner diameter) and has a certain height (about 5mm from the surface of the eyeball) and is maintained perpendicular to the surface of the eyeball. The eyelid supports 2 are provided with an upper baffle and a lower baffle which are symmetrically distributed and are formed by two baffles which are arranged in tandem and form a certain angle (about 120 degrees), and the included angle of the two front baffles is about 60 degrees. The thickness of the front baffle and the rear baffle is about 1.5 mm; the front baffle is of a fan-shaped structure, the included angle of two sides is about 80 degrees, and the height is about 6 mm; two convex, bilaterally symmetrical and radian-shaped supporting beams 3 are arranged near the inner ring of the front surface of the auxiliary device and are connected with a fixing ring 1 and an eyelid support 2.

As shown in fig. 3, the wider side of the front surface of the fixing ring 1 is provided with two convex cylindrical structures 4 (arranged in a ">" or "<" shape, with the opening facing outwards and an included angle of about 45 °) which are symmetrical up and down and correspond to the temporal side of the eyeball; each cylindrical structure 4 is internally provided with 3 tube cavities 5 which are arranged in a straight line, and the distances from the cylindrical structures to the corneal limbus are respectively 3.0mm, 3.5mm and 4.0 mm; furthermore, each lumen 5 is thin (about 0.4mm inner diameter) and has a certain height (about 5mm from the surface of the eyeball) and is maintained perpendicular to the surface of the eyeball. The eyelid supports 2 are provided with an upper baffle and a lower baffle which are symmetrically distributed and are formed by two baffles which are arranged in tandem and form a certain angle (about 120 degrees), and the included angle of the two front baffles is about 60 degrees.

As shown in fig. 4, the center of the fixing ring 1 is hollowed, and has an elliptical shape, a vertically symmetrical shape, and a laterally asymmetrical shape (one side is wide and the other side is narrow). The rear surface of the fixing ring 1 is a spherical surface with a hollow center, the radius of the spherical surface is approximately equal to 1/2, and the spherical surface is completely attached to the eyeball surface; the wider side is provided with 3 tube cavities 5 which are arranged in a straight line and are symmetrical up and down, the tube cavities are arranged in a shape of '>' or '<', the openings face outwards, the included angle is about 45 degrees, the tube cavities always correspond to the temporal side of the eyeball, and the distances from the temporal side to the corneal limbus are respectively 3.0mm, 3.5mm and 4.0 mm; the inner ring of the fixing ring 1 is similar to a cross shape, is adjacent to the corneal limbus, is in a semicircular arc shape from top to bottom, and has symmetrical radian defects 6 from left to right. The eyelid supports 2 are symmetrically arranged with an upper part and a lower part.

As shown in fig. 5, the wider side of the front surface of the fixing ring 1 has a convex cylindrical structure 4 corresponding to the temporal side of the eyeball; the cylindrical structure 4 is internally provided with 3 tube cavities 5 which are arranged in a straight line, and the distances from the cylindrical structure to the corneal limbus are respectively 3.0mm, 3.5mm and 4.0 mm; furthermore, each lumen 5 is thin (about 0.4mm inner diameter) and has a certain height (about 5mm from the surface of the eyeball) and is maintained perpendicular to the surface of the eyeball. The eyelid support 2 is composed of two baffles which are arranged in tandem and form a certain angle (about 120 degrees), and the included angle of the two front baffles is about 60 degrees. The supporting beam 3 near the inner ring of the front surface is connected with the fixed ring 1 and the eyelid support 2.

The operation of the auxiliary device for vitreous cavity injection according to the present invention for vitreous cavity injection is described in detail below with reference to the accompanying drawings:

as shown in fig. 1 to 5, the auxiliary device for vitreous cavity injection of the present invention comprises a fixing ring 1, an eyelid support 2 and a support beam 3 connecting the fixing ring and the eyelid support, and can select a suitable size according to the size of an eyeball, and can assist in safely and effectively injecting a drug into a vitreous cavity, the position and the depth of drug administration are relatively fixed, the use is convenient, the operation is simple, the risk of the operation can be reduced, the operation efficiency is improved, and the auxiliary device for vitreous cavity injection meets the requirements of human engineering.

The auxiliary device for vitreous cavity injection of the invention is used for the specific operation process of the vitreous cavity injection as follows:

firstly, flushing the conjunctival sac with normal saline, advising the patient to lie on an operation bed, after the anesthesia of the surface of an operation eye takes effect, carrying out conventional disinfection by povidone iodine, paving an operation hole towel, and pasting an eye pad; secondly, taking out the sterilized auxiliary vitreous cavity injection device with proper size selected according to the size of the eyeball, so that the wider side cylindrical structure 4 on the front surface of the fixing ring 1 is always kept corresponding to the temporal side of the eyeball (the fixing ring is placed upside down to adapt to the difference of eyes); then, the forefinger and the thumb are respectively placed on an upper front baffle and a lower front baffle of the eyelid support 2, the fixing ring 1 can be folded by involution pressing with upper and lower forces, the upper back baffle and the lower back baffle are sequentially placed between the eyeball and the eyelid, and the front baffle prevents the eyelid from being closed, so that the eyelid is opened; then, order the patient to watch the patient by lighting right above, adjust the positions of the inner ring and the limbus of the fixing ring 1, make the vitreous cavity injection auxiliary device be positioned in the center of the eyeball, and make the rear surface of the fixing ring 1 completely fit with the surface of the eyeball to limit the movement of the eyeball, at this time, use 30G or 33G injection needle to insert needle on the temporal side (superotemporal or inferotemporal) of the eyeball through one of 3 lumens 5 (the distance from the limbus is 3.0mm, 3.5mm, 4.0mm respectively) in the cylindrical structure 4 on the fixing ring 1, generally choose 3.5mm or 4.0mm (specifically according to the size of the eyeball and the crystalline lens state of the injected eye), then insert needle 5-7mm to the central position of the eyeball, slowly inject medicine, extract the needle after the medicine is injected, make the position of the fixing ring 1 shift slightly immediately and press the needle eye 1min left or right to prevent the medicine from flowing backwards; finally, the eye is coated with antibiotic eye ointment and gauze is used for sealing the eye.

Claims

1. An auxiliary device for vitreous cavity injection, which can adjust the proper size according to the size of eyeball, is characterized in that the auxiliary device is composed of a fixing ring, an eyelid support and a supporting beam,

the center of the fixing ring is hollowed out, the appearance of the fixing ring is similar to an ellipse, the fixing ring is provided with a front surface and a rear surface, an inner ring and an outer ring, the front surface and the rear surface are vertically symmetrical, the left surface and the right surface are asymmetrical, one side of the fixing ring is wide, and the other side of the; the wider side of the front surface of the fixing ring is provided with two convex cylindrical structures which are symmetrical up and down and correspond to the temporal side of the eyeball, each cylindrical structure is internally provided with 3 tube cavities, and each tube cavity is vertical to the surface of the eyeball; the rear surface of the fixing ring is a spherical surface with a hollow center, the spherical radius of the fixing ring is approximately equal to 1/2 eye axes, and the spherical radius of the fixing ring is approximately equal to the radius of an eyeball and is completely attached to the surface of the eyeball; the inner ring of the fixing ring is adjacent to the corneal limbus, the upper part and the lower part of the fixing ring are in a semicircular arc shape, and the left side and the right side of the fixing ring are respectively provided with a symmetrical radian defect;

2. The auxiliary device for intravitreal injection according to claim 1, wherein the auxiliary device is made of polypropylene, silicone or 3D printed material.

3. An auxiliary device for intravitreal injection according to claim 1 or 2, characterized in that the diameter of the eye is referenced to 24mm, the thickness of the securing ring is 1.5mm, the width of the wider side of the securing ring is 5mm, the width of the narrower side is 3mm, the outer diameter of the securing ring is 21.5mm and the inner diameter is 19.5 mm.

4. An aid for a vitreous cavity injection as claimed in claim 3, wherein the cylindrical structures are arranged in a ">" or "<" shape with the openings facing outwards at an angle of 45 °, a length of 2.4mm, a thickness of 1.2mm and a height of 3.5 mm.

5. An aid for intravitreal injection according to claim 4, characterized in that the 3 lumens are at a distance of 3.0mm, 3.5mm, 4.0mm from the limbus, respectively; each lumen has an inner diameter of 0.4mm and a height of 5mm from the surface of the eyeball.

6. An aid for intravitreal injection according to claim 3, characterized in that the inner ring of the retaining ring is cruciform-like, with a semicircular arc with a vertical diameter of 11.5mm, a radian-like defect width of 6.0mm, a height of 1.0mm and a transverse diameter of 13.5 mm.

7. An aid for a vitreous cavity injection according to claim 3, characterized in that the angle between the front and rear flaps of the eyelid support is 120 °, the angle between the two front flaps is 60 °; the thickness of the front baffle and the rear baffle is 1.5 mm; the front baffle is of a fan-shaped structure, the included angle of two sides of the fan-shaped structure is 80 degrees, and the height of the front baffle is 6 mm; the height of the tailgate was 4 mm.

8. A supplemental device for a vitreous chamber injection as claimed in claim 3, wherein the support beam is 1.0mm thick.