CN112603646A

CN112603646A - Suprachoroidal space syringe

Info

Publication number: CN112603646A
Application number: CN202011514508.5A
Authority: CN
Inventors: 龙达; 周征兵; 申济奎
Original assignee: Shanghai Changheng Biotechnology Co ltd
Current assignee: Shanghai Sixth Peoples Hospital
Priority date: 2020-12-21
Filing date: 2020-12-21
Publication date: 2021-04-06

Abstract

The invention discloses a suprachoroidal space injector, which comprises an injector and a needle head, wherein the side surface of the injector is provided with a needle outlet which is an opening with a cambered surface; the syringe needle is L column structure, and the syringe needle is including injection portion and the main part that is linked together, and injection portion is just to going out the needle mouth setting, and main part slidable ground links to each other with the injector, and the main part is connected with and hinders the needle ware, and the one end that hinders the needle ware links to each other with the main part, and the injector is stretched out to the other end slidable ground that hinders the needle ware, hinders the needle ware and can drive the syringe needle and reciprocate to slide, and the syringe needle slides reciprocally and can drive injection portion. During injection, the injector is perpendicular to the sclera arc fixed point, the needle head is driven to move by the needle blocking device, the injection part extends out of the needle outlet, the perpendicular needle inserting direction in the prior art is changed into parallel needle inserting, the translation puncture enters the sclera, and after the medicine is injected, the needle head is driven to reset by the needle blocking device, so that the sclera puncture port is prevented from being torn due to the perpendicular needle outlet of misoperation.

Description

Suprachoroidal space syringe

Technical Field

The invention relates to the technical field of intraocular injection equipment, in particular to a suprachoroidal space injector.

Background

Successful treatment of ocular diseases depends not only on the development of novel drugs, but also on effective methods of administration to increase the concentration of the drug in the target tissue to achieve the desired effect. Over the past 17 years, researchers have been actively exploring new ways to deliver drugs, cells, implants and other fluids to treat various eye conditions and reduce the blinding rate. Many successful or promising clinical trials and experimental studies have focused on testing the pharmaceutical technology using three intraocular injection techniques: intravitreal (IVT), Subretinal (SR), and Suprachoroidal (SC) injections. Typical methods for these injections are shown in figure 1. Among them, IVT injection was the most successful and some heavy products were introduced into the market, such as ranibizumab, aflibercept, combaici. However, the intravitreal injection method cannot sufficiently transduce the target gene to the photoreceptor due to the Inner Limiting Membrane (ILM) barrier. Although the transfection efficiency can be improved by removing the inner limiting membrane by using a surgical method, the corresponding surgical risk is increased, thereby limiting the application of the method in the field of gene therapy. SR injection is widely used in gene therapy and cell transplantation for hereditary retinal diseases, such as Leber congenital amaurosis, Retinitis Pigmentosa (RP), Stargardt's macular degeneration. However, as the most invasive method of intraocular injection, the potential surgical risks such as vitreous loss, retinal detachment and hemorrhage all discourage SR multi-site repeat injections.

As an emerging field of importance in ophthalmology, suprachoroidal injection has gained increasing attention in recent years in its minimally invasive and repeatable characteristics. The micro-needle is less invasive and more effective than conventional needles in placing the desired materials of different shapes and sizes into the suprachoroidal space, reducing damage to the retinal layer. The key to SCS injection is the need to place the drug or gene directly in the potential cavity between the sub-scleral and suprachoroidal space, without puncturing the choroidal vessels or disrupting any underlying tissue structures. The ideal length should therefore be comparable to the scleral thickness, and in view of this necessity the needle length has been reduced to the size of a micron, i.e. less than 1 mm. SCS-specific syringes are not as diverse as IVT needles, and the products for clinical use are very few and imperfect.

In the prior art, Visionsti changes a hypodermic needle of normal length into a suprachoroidal needle by controlling the length of the needle tip in an adapter in the current SCS syringe at home and abroad. The adapter is combined with the needle guide for injection, and the adapter can keep the eyelid open and stabilize the eyeball. Scsmucroinjormtm has obtained FDA approved suprachoroidal injections for triamcinolone acetonide suspensions in 2019 and entered china 3 months 2020. Both the two special injectors are in a needle inserting mode perpendicular to the sclera, and although the length of the needle head is adjustable, the injection accuracy of the suprachoroidal space cannot be completely ensured in the practical application process due to the fact that the sclera thickness has individual difference and difference of different health states. The suprachoroidal delivery system of the ETHICON ENDO-SURGERY, INC. design includes a body, a cannula, a hollow needle, and an actuation assembly. The structure is relatively complex, the requirement on the proficiency of the operation technology is high, and the clinical popularization and application are not facilitated. The tissue-targeting smart syringe (I2T2) designed by harvard medical college is similar to a conventional syringe in that when pressure is applied to the plunger, the needle head is designed to move independently of the barrel and into the harder outer tissue through the connector components, and when the needle reaches the soft target tissue, the mechanical feedback effect stops the advancement of the needle and the plunger pushes the drug out of the tip. Compared with the above syringes, the design is simple and convenient, the precision is improved, but the requirements on the needle inserting speed and the stability of an injector in the actual operation are very high, and the requirements are not favorable for clinicians with insufficient experience to master, so that the popularization and the application are difficult.

Therefore, how to change the current situation that the suprachoroidal space injector in the prior art is complicated in structure, difficult to operate and incapable of ensuring accuracy becomes a problem to be solved urgently by those skilled in the art.

Disclosure of Invention

The invention aims to provide a suprachoroidal space injector, which solves the problems in the prior art, reduces the operation difficulty of the injector and improves the accuracy of the injector.

In order to achieve the purpose, the invention provides the following scheme: the invention provides a suprachoroidal space injector, which comprises an injector and a needle head, wherein the injector and the needle head can be connected with the existing injector; the injection part is arranged right opposite to the needle outlet, the main body part is connected with the injector in a sliding mode, the main body part is connected with the needle blocking device, one end of the needle blocking device is connected with the main body part, the other end of the needle blocking device extends out of the injector in a sliding mode, the relative sliding direction of the needle blocking device and the injector is parallel to the axis of the injection part, the needle blocking device can drive the needle to slide in a reciprocating mode, and the needle to slide in a reciprocating mode can drive the injection part to extend out of the needle outlet.

Preferably, the injector comprises a limiting section and a connecting section which are connected, one end of the limiting section, which is far away from the connecting section, is provided with a limiting end face, and the injection part is slidably abutted to the limiting end face.

Preferably, the needle stopper is slidably connected with the connecting section, an elastic part is arranged between the main body part and the connecting section, and the deformation direction of the elastic part is parallel to the relative sliding direction of the connecting section and the needle stopper.

Preferably, the number of the elastic parts is three, wherein two groups of the elastic parts are respectively arranged on two sides of the needle blocker, and the other group of the elastic parts is coaxially arranged with the needle blocker; the elastic piece is a spring.

Preferably, a separation blade and a clamping block are arranged between the needle blocking device and the connecting section, the separation blade is connected with the needle blocking device, the clamping block is connected with the connecting section, and the separation blade can be clamped with the clamping block.

Preferably, the injector comprises a control window, a sliding block is arranged at the control window, the sliding block is slidably connected with the control window, the relative sliding direction of the sliding block and the control window is parallel to the relative sliding direction of the needle stopper and the injector, and the sliding block is connected with the needle.

Preferably, the axis of the injection part and the axis of the main body part form an angle of 90 °.

Preferably, the junction of the injection part and the main body part is rounded.

Compared with the prior art, the invention has the following technical effects: the suprachoroidal space injector comprises an injector and a needle head, wherein the injector and the needle head can be connected with the existing injector, the needle head is arranged in the injector, a needle outlet is formed in the side surface of the injector, and the needle outlet is an opening with a cambered surface; the syringe needle is L column structure, and the syringe needle is including injection portion and the main part that is linked together, and injection portion is just to going out the needle mouth setting, and main part slidable links to each other with the injector, and the main part is connected with and hinders the needle ware, and the one end that hinders the needle ware links to each other with the main part, and the injector is stretched out to the other end slidable of hindering the needle ware, hinders the relative sliding direction of needle ware, injector and parallels with the axis of injection portion, hinders the needle ware and can drive the syringe needle and slide, and the syringe needle slides to and fro and can drive. When the suprachoroidal space injector is used, the injector and the needle head can be connected with the existing injector to absorb medicines, the side surface of the injector is provided with the needle outlet, the needle head is L-shaped, the needle head comprises an injection part and a main body part, the injector is perpendicular to the sclera arc fixed point during injection, the needle head is driven to move by the needle stopper, the injection part extends out of the needle outlet, the vertical needle inserting direction in the prior art is changed into parallel needle inserting, translational puncture is carried out to enter the sclera, after medicines are injected, the needle head is driven to reset by the needle stopper, the sclera puncture port is prevented from being torn due to misoperation of vertical needle outlet, and meanwhile, the arc-shaped outline structure of the needle outlet can press the puncture port to prevent the medicines from flowing back after the needle. The suprachoroidal space injection gun adopts a parallel needle insertion mode, and the injection part punctures the scleral surface and then separates the inner surface of the sclera from the outer surface of the choroid in parallel by using the physical action, so that the potential lacuna becomes practical, and the accidental injury rate of adjacent tissues can be reduced to the minimum. Meanwhile, the mechanically separated suprachoroidal space is more beneficial to the medicine or cells entering the cavity space, and the push injection pressure and the fluid power are beneficial to further maintaining the cavity space and helping the injected liquid to disperse along the cavity space. The suprachoroidal space injector is simple and convenient to operate, high in accuracy and free of accidental injury to peripheral tissues, and the applicability of the injector is improved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.

FIG. 1 is a cross-sectional view of the suprachoroidal space injector of the present invention;

FIG. 2 is a schematic structural view of another state of the suprachoroidal space injector of the present invention;

the suprachoroidal space injector 100 is the suprachoroidal space injector of the present invention, 1 is a syringe injector, 2 is a needle head, 3 is a needle outlet, 4 is an injection part, 5 is a main body part, 6 is a needle stopper, 7 is a limiting section, 8 is a connecting section, 9 is an elastic part, 10 is a blocking piece, 11 is a clamping block, 12 is a control window, 13 is a sliding block, and 14 is a limiting end face.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in further detail below.

Referring to fig. 1-2, fig. 1 is a cross-sectional view of the suprachoroidal space injector of the present invention, and fig. 2 is a cross-sectional view of another embodiment of the suprachoroidal space injector of the present invention.

The invention provides a suprachoroidal space injector 100, which comprises an injector 1 and a needle head 2, wherein the injector 1 and the needle head 2 can be connected with the existing injector, the needle head 2 is arranged in the injector 1, the side surface of the injector 1 is provided with a needle outlet 3, and the needle outlet 3 is an opening with an arc surface; syringe needle 2 is L column structure, syringe needle 2 is including injection portion 4 and main part 5 that are linked together, injection portion 4 is just to going out needle mouth 3 setting, main part 5 slidable ground links to each other with injection pushing device 1, main part 5 is connected with and hinders needle ware 6, the one end that hinders needle ware 6 links to each other with main part 5, the other end slidable ground that hinders needle ware 6 stretches out injection pushing device 1, hinder needle ware 6, the relative sliding direction of injection pushing device 1 parallels with the axis of injection portion 4, it can drive 2 reciprocating sliding of syringe needle to hinder

needle ware

6, 2 reciprocating sliding of syringe needle can drive injection portion 4 and stretch out by going out needle mouth 3.

When the suprachoroidal space injector 100 is used, the injector 1 and the needle 2 can be connected with the existing injector to absorb medicines, the needle outlet 3 is arranged on the side surface of the injector 1, the needle 2 is L-shaped, the needle 2 comprises the injection part 4 and the main body part 5, during injection, the injector 1 is perpendicular to the sclera arc fixed point, the needle 2 is driven to move by the needle blocker 6, the injection part 4 extends out of the needle outlet 3, the vertical needle inserting direction in the prior art is changed into parallel needle inserting, translational puncture is carried out on the sclera, after medicines are injected, the needle blocker 6 is used for driving the needle 2 to reset, the sclera puncture port is prevented from being torn due to the fact that the needle is perpendicularly withdrawn by misoperation, and meanwhile, the arc-shaped outline structure of the needle outlet 3 can press the puncture port to prevent the medicines from flowing back after the. The suprachoroidal space injection gun adopts a parallel needle insertion mode, and the injection part 4 punctures the scleral surface and then separates the inner surface of the sclera from the outer surface of the choroid in parallel by using physical action, so that potential lacuna becomes practical, and the accidental injury rate of adjacent tissues can be reduced to the lowest. Meanwhile, the mechanically separated suprachoroidal space is more beneficial to the medicine or cells entering the cavity space, and the push injection pressure and the fluid power are beneficial to further maintaining the cavity space and helping the injected liquid to disperse along the cavity space. The suprachoroidal space injector 100 of the present invention is simple to operate, has high accuracy, does not accidentally injure surrounding tissues, and improves the applicability of the injector.

Wherein, injector 1 includes spacing section 7 and linkage segment 8 that link to each other, and spacing section 7 is kept away from the one end of linkage segment 8 and is had spacing terminal surface 14, and injection part 4 slidable ground is with spacing terminal surface 14 looks butt. The limiting end surface 14 can provide a supporting and limiting function for the injection part 4, and the injection part 4 can extend out of the needle outlet 3 by sliding relative to the limiting end surface. In addition, in other embodiments of the present invention, when the injection part 4 is fully extended, the main body part 5 is in contact with the limiting section 7, and the diameter of the limiting section 7 is reasonably set, so that the maximum displacement position of the needle head 2 can be limited, excessive displacement of the injection part 4 can be avoided, and the safety factor of the injector can be improved.

After the injection is accomplished, in order to make needle blocking device 6 reset smoothly, needle blocking device 6 slidable ground links to each other with linkage segment 8, set up elastic component 9 between main part 5 and the linkage segment 8, the deformation direction and the linkage segment 8 of elastic component 9, the relative slip direction of needle blocking device 6 parallels, promote to block needle blocking device 6 compression elastic component 9 and drive syringe needle 2 and accomplish the back of injecting, under the effort of elastic component 9 recovery deformation, needle blocking device 6 resets smoothly, in addition, in the injection process, elastic component 9 can also play flexible loading, the effect of slowing down the impact, further improve the injection precision.

In this embodiment, the number of the elastic members 9 is three, wherein two sets of the elastic members 9 are respectively disposed on two sides of the needle blocker 6, the other set of the elastic members 9 is disposed coaxially with the needle blocker 6, and the distances between the elastic members 9 disposed on two sides of the needle blocker 6 and the needle blocker 6 are equal, so as to improve the motion stability of the needle blocker 6, and in addition, the elastic members 9 are springs, so that the needle blocker is inexpensive and convenient to replace.

Specifically, a blocking piece 10 and a clamping block 11 are arranged between the needle blocking device 6 and the connecting section 8, the blocking piece 10 is connected with the needle blocking device 6, the clamping block 11 is connected with the connecting section 8, and the blocking piece 10 can be clamped with the clamping block 11. When the injector is at the initial position, the baffle piece 10 is clamped with the clamping block 11, so that misoperation can be avoided; when in injection, the needle stopper 6 is pressed down, the blocking piece 10 is separated from the fixture block 11, the injection part 4 of the needle head 2 extends out of the needle outlet 3, and the injection is finished.

More specifically, the injector 1 comprises a control window 12, a sliding block 13 is arranged at the control window 12, the sliding block 13 is slidably connected with the control window 12, the relative sliding direction of the sliding block 13 and the control window 12 is parallel to the relative sliding direction of the needle blocker 6 and the injector 1, and the sliding block 13 is connected with the needle 2. The control window 12 is matched with the sliding block 13, so that the movement track and the limit position of the needle head 2 can be limited, and the safety factor of injection operation is ensured.

In the present embodiment, the included angle between the axis of the injection part 4 and the axis of the main body part 5 is 90 °, and the connection between the injection part 4 and the main body part 5 is rounded, so as to reduce the resistance of the medicine flowing in the needle 2, and make the medicine injected smoothly.

According to the suprachoroidal space injector 100, during injection, the injector 1 is perpendicular to the sclera arc fixed point, the needle head 2 is driven to move by the needle blocker 6, the injection part 4 extends out of the needle outlet 3, the vertical needle inserting direction in the prior art is changed into parallel needle inserting, translational puncture is carried out on the sclera, after medicine is injected, the needle blocker 6 is used for driving the needle head 2 to reset, the sclera puncture port is prevented from being torn due to the fact that the needle is perpendicularly discharged by misoperation, and meanwhile, the arc-shaped outline structure of the needle outlet 3 can press the puncture port to prevent medicine backflow after the needle is discharged. The suprachoroidal space injection gun adopts a parallel needle insertion mode, and the injection part 4 punctures the scleral surface and then separates the inner surface of the sclera from the outer surface of the choroid in parallel by using physical action, so that potential lacuna becomes practical, and the accidental injury rate of adjacent tissues can be reduced to the lowest. Meanwhile, the mechanically separated suprachoroidal space is more beneficial to the medicine or cells entering the cavity space, and the push injection pressure and the fluid power are beneficial to further maintaining the cavity space and helping the injected liquid to disperse along the cavity space. The suprachoroidal space syringe 100 of the present invention is simple to operate, has high accuracy, does not accidentally injure surrounding tissues, and consumes only 20 seconds per time. At present, the research on suprachoroidal space injection in China is relatively lagged, and the suprachoroidal space injector 100 can promote the clinical popularization of the suprachoroidal space administration mode and has wide application prospect.

The principle and the implementation mode of the invention are explained by applying a specific example, and the description of the embodiment is only used for helping to understand the method and the core idea of the invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, the specific embodiments and the application range may be changed. In view of the above, the present disclosure should not be construed as limiting the invention.

Claims

1. A suprachoroidal space syringe, comprising: the injector comprises an injector and a needle head, wherein the injector and the needle head can be connected with an existing injector, the needle head is arranged in the injector, a needle outlet is formed in the side surface of the injector, and the needle outlet is an opening with an arc surface; the injection part is arranged right opposite to the needle outlet, the main body part is connected with the injector in a sliding mode, the main body part is connected with the needle blocking device, one end of the needle blocking device is connected with the main body part, the other end of the needle blocking device extends out of the injector in a sliding mode, the relative sliding direction of the needle blocking device and the injector is parallel to the axis of the injection part, the needle blocking device can drive the needle to slide in a reciprocating mode, and the needle to slide in a reciprocating mode can drive the injection part to extend out of the needle outlet.

2. The suprachoroidal space syringe of claim 1, wherein: the injection device comprises a limiting section and a connecting section which are connected, one end of the limiting section, which is far away from the connecting section, is provided with a limiting end face, and the injection part can be slidably abutted against the limiting end face.

3. The suprachoroidal space syringe of claim 2, wherein: the needle stopper is connected with the connecting section in a sliding mode, an elastic piece is arranged between the main body portion and the connecting section, and the deformation direction of the elastic piece is parallel to the relative sliding direction of the connecting section and the needle stopper.

4. The suprachoroidal space syringe of claim 3, wherein: the number of the elastic parts is three, wherein two groups of the elastic parts are respectively arranged on two sides of the needle stopper, and the other group of the elastic parts is coaxially arranged with the needle stopper; the elastic piece is a spring.

5. The suprachoroidal space syringe of claim 2, wherein: and a separation blade and a clamping block are arranged between the needle blocking device and the connecting section, the separation blade is connected with the needle blocking device, the clamping block is connected with the connecting section, and the separation blade can be clamped with the clamping block.

6. The suprachoroidal space syringe of claim 1, wherein: the injector comprises a control window, a sliding block is arranged at the position of the control window, the sliding block can be slidably connected with the control window, the relative sliding direction of the sliding block and the control window is parallel to the relative sliding direction of the needle stopper and the injector, and the sliding block is connected with the needle head.

7. The suprachoroidal space syringe of claim 1, wherein: the included angle between the axis of the injection part and the axis of the main body part is 90 degrees.

8. The suprachoroidal space syringe of claim 1, wherein: the connection part of the injection part and the main body part is rounded.