CN118512302B

CN118512302B - Sustained release drug delivery system for eyes

Info

Publication number: CN118512302B
Application number: CN202410988984.2A
Authority: CN
Inventors: 王琰; 国良; 王佳玉; 张婷婷; 阚敏
Original assignee: Suzhou Langmu Medical Technology Co ltd
Current assignee: Suzhou Langmu Medical Technology Co ltd
Priority date: 2024-07-23
Filing date: 2024-07-23
Publication date: 2024-10-01
Anticipated expiration: 2044-07-23
Also published as: CN118512302A

Abstract

The invention provides an ophthalmic sustained release drug delivery system, which comprises a push injector and a loader, wherein the push injector is used for implanting sustained release drugs into eyes, the loader is used for loading the sustained release drugs into the push injector, and the sustained release drugs are granular rather than liquid and can be loaded into needle tubes of the push injector through the loader so as to be delivered into the eyes; the injector is provided with an ejection button and a pushing mechanism, the pushing mechanism can act on the slow release medicine, the slow release medicine can be ejected into eyes after being triggered by the ejection button, the injector has a simple integral structure, the injector is convenient to use, the slow release medicine implantation process is rapid, and the learning curve of an operator is short; the loader can rapidly, conveniently and accurately load slow release drugs into the injector, and comprises a carrier component and a drug delivery component, wherein the carrier component is used for carrying and fixing the injector; the medicine delivery assembly and the medicine delivery assembly are in relative sliding fit in the longitudinal direction, so that the medicine delivery assembly and the medicine delivery assembly can be far away from or close to each other, and the medicine delivery assembly is used for loading slow release medicine into the injector.

Description

Sustained release drug delivery system for eyes

Technical Field

The application relates to the technical field of medical equipment, in particular to an ophthalmic sustained-release drug delivery system.

Background

Currently, drug therapy is the most common treatment for ophthalmic diseases, and conventional drug therapy adopts the form of eye drops, i.e., eye drops are applied on the ocular surface. However, the use compliance of the medicines is poor, most eye drops flow out along with tears, the utilization rate of the medicines is low, and the treatment effect is poor.

Accordingly, with the development of technology, the implantation of sustained release drugs into the desired site in the eye, such as the anterior chamber, posterior chamber, and intraretinal, subretinal, choroidal space, etc., through delivery devices has emerged. Due to the long-acting property of the slow-release drugs, the slow-release drugs are continuously released after being implanted into eye tissues, so that the frequency of frequent administration required by patients is reduced, and the patients do not need to frequently use eyedrops or smear ointments, thereby improving the convenience of treatment and the compliance of the patients.

The delivery system for delivering the sustained release drug into the eye (the drug referred to herein is a granular drug and is not a liquid drug) generally adopts a slow push injection mode or adopts an ejection delivery mode, but the existing delivery system still needs to be optimized and improved in the aspects of loading the sustained release drug and the structural function of the push injector so as to meet the accurate implantation requirement of the sustained release drug for the particles in the eye.

Disclosure of Invention

In order to solve the above technical problems, the present application provides an ophthalmic sustained release drug delivery system, including a syringe for implanting sustained release drug into an eye, comprising: a housing forming a handle portion of the injector; the ejection button is partially exposed out of the shell; a needle cannula fixed to the head end of the handle portion, the needle cannula insertable into an eye and containing the slow release drug therein; the pushing mechanism is arranged in the shell and can act on the slow-release medicine, and can longitudinally move in the shell after being triggered by the ejection button so as to eject the slow-release medicine into eyes; a loader for loading a slow release drug into the bolus comprising: the carrying assembly is used for carrying and fixing the injector; and the medicine delivery assembly is in relative sliding fit with the carrying assembly in the longitudinal direction, so that the carrying assembly and the medicine delivery assembly can be far away from or close to each other, and the medicine delivery assembly is used for loading slow release medicine into the needle tube.

In some embodiments of the application, the ejector button includes a pressing portion exposed on the surface of the housing and a guide portion having a longitudinal guide channel.

In some embodiments of the present application, the pushing mechanism includes a push rod, an elastic member, and a push wire, one end of the push wire is connected to the push rod, the other end of the push wire acts on the slow release drug, and the elastic member acts on the push rod; when the injector is in a state before ejection, the push rod is stopped at the ejection button, when the injector is in an ejection state, the pressing part is pressed to enable the ejection button to move towards the inside of the shell, and the push rod enters the guide channel under the elasticity of the elastic piece and drives the push wire to move so as to eject the slow-release medicine from the needle tube.

In some embodiments of the application, at least one positive stop is provided in the housing such that the guide portion stops against the positive stop when the ejector button is displaced into the housing.

In some embodiments of the application, both sides of the guide portion have first grooves; the guide part is further provided with a first deformation arm arranged in the first slot, the shape of the first deformation arm is matched with that of the first slot, a first protrusion is arranged on the outer side of the first deformation arm, a second protrusion is arranged on the inner wall of the shell, and the first protrusion can be clamped with the second protrusion.

In some embodiments of the present application, the needle cannula is provided with a working hole in a radial direction near a distal end thereof, and the injector further comprises a limiting plunger inserted into the working hole to limit the slow release medicine from falling from the distal end of the needle cannula when not ejected after loading, and the limiting plunger is removed in an ejected state, and the working hole is used for exhausting air in the needle cannula.

In some embodiments of the application, the drug delivery assembly comprises: a loading bay having a loading portion adjacent the carrier assembly, the loading portion for providing a loading space for the slow release drug and the needle cannula; the pushing piece is in sliding fit with the loading seat in the longitudinal direction; and one end of the jackscrew is fixedly connected with the pushing piece, and the other end of the jackscrew can act on the slow-release medicine so as to drive the jackscrew to push the slow-release medicine into the needle tube when the pushing piece is allowed to move along the longitudinal direction of the loading seat.

In some embodiments of the present application, the loading portion has a limiting groove for limiting the position of the needle tube and a positioning hole for positioning the jackscrew, wherein the central axis of the jackscrew, the central axis of the positioning hole and the central axis of the needle tube are coaxial.

In some embodiments of the present application, the loading seat is provided with a mounting groove, the loading part is interchangeably fixed in the mounting groove, the loading part is provided with at least one transverse rib at intervals in the longitudinal direction, and the positioning hole penetrates through the transverse rib.

In some embodiments of the application, the carrier assembly includes a carrier having a sliding cavity; the loading seat comprises a loading base and a loading top seat, the loading part is positioned on the loading top seat, and the loading base is in sliding fit with the sliding cavity.

In some embodiments of the application, the delivery system further comprises a loading track, and the carrier assembly further comprises a driving unit, wherein the driving unit can drive the carrier assembly to move along the loading track so as to approach the drug delivery assembly for loading the slow release drug or keep away after the slow release drug is loaded.

In some embodiments of the present application, a carrier cavity adapted to the injector is provided on the top of the stage along the longitudinal direction, so that the injector can be accommodated and fixed in the carrier cavity.

The application has the beneficial effects that: the application provides an ophthalmic sustained release drug delivery system, which comprises a push injector and a loader, wherein the push injector is used for implanting sustained release drugs into eyes, the loader is used for loading the sustained release drugs into the push injector, and the sustained release drugs are granular rather than liquid and can be loaded into needle tubes of the push injector through the loader so as to be delivered into the eyes; the injector is provided with an ejection button and a pushing mechanism, the pushing mechanism can act on the slow release medicine, the slow release medicine can be ejected into eyes after being triggered by the ejection button, the injector has a simple integral structure, the injector is convenient to use, the slow release medicine implantation process is rapid, and the learning curve of an operator is short; the loader of the conveying system comprises a carrying component and a medicine conveying component, wherein the carrying component is used for carrying and fixing the injector; the medicine delivery assembly and the medicine delivery assembly are in relative sliding fit in the longitudinal direction, so that the medicine delivery assembly and the medicine delivery assembly can be mutually far away or close to each other, the medicine delivery assembly is used for loading slow release medicine into the injector, and the loader of the slow release medicine conveying system can quickly, conveniently and accurately load the slow release medicine into the injector, so that the medicine loading efficiency is improved.

Drawings

For a clearer description of the technical solutions in the embodiments of the application, the drawings that are needed in the description of the embodiments will be briefly introduced below, it being obvious that the drawings in the following description are only some embodiments of the application, from which, without inventive effort, further drawings can be obtained for a person skilled in the art, in which:

FIG. 1A is a perspective view of one embodiment of a bolus in an ophthalmic extended release drug delivery system of the present invention;

FIG. 1B is a schematic diagram of the internal structure of one embodiment of a bolus in an ophthalmic extended release drug delivery system according to the present invention;

FIG. 1C is an exploded schematic view of the internal structure of one embodiment of a bolus in an ophthalmic extended release drug delivery system according to the present invention;

FIG. 1D is a perspective view of an ejection button of one embodiment of a bolus of an ophthalmic extended release drug delivery system of the present invention;

FIG. 1E is a perspective view of the head end of one embodiment of a bolus in an ophthalmic extended release drug delivery system of the present invention;

FIG. 1F is a schematic view of a needle cannula and stopper of one embodiment of a bolus in an ophthalmic extended release drug delivery system of the present invention;

FIG. 1G is a partial cross-sectional view of one embodiment of a bolus in an ophthalmic extended release drug delivery system of the present invention;

FIG. 1H is a cross-sectional view of one embodiment of a bolus in an ophthalmic extended release drug delivery system of the present invention;

FIG. 1I is an assembled view of a protective cap of an embodiment of a bolus in an ophthalmic extended release drug delivery system of the present invention;

FIG. 1J is a perspective view of a protective cap of an embodiment of a bolus in an ophthalmic extended release drug delivery system of the present invention;

FIG. 1K is a schematic view of a first housing and a second housing of an embodiment of a bolus in an ophthalmic extended release drug delivery system of the present invention;

FIG. 2A is a schematic internal structure of another embodiment of a bolus in an ophthalmic extended release drug delivery system according to the present invention;

FIG. 2B is a bottom view of another embodiment of a bolus in the ocular slow release drug delivery system of the present invention;

FIG. 3A is a perspective view of one embodiment of a cartridge in an ophthalmic extended release drug delivery system of the present invention;

FIG. 3B is a perspective view of a carrier assembly of one embodiment of a cartridge in an ophthalmic extended release drug delivery system of the present invention;

FIG. 3C is a perspective view of a drug delivery assembly of one embodiment of a cartridge in an ophthalmic extended release drug delivery system of the present invention;

FIG. 3D is a top view of one embodiment of a cartridge in an ophthalmic extended release drug delivery system of the present invention;

FIG. 3E is an enlarged partial schematic view of FIG. 3D;

FIG. 3F is a perspective view of a loading portion of one embodiment of a loader in an ophthalmic extended release drug delivery system of the present invention;

FIG. 4A is a perspective view of a drug delivery assembly of another embodiment of a cartridge in an ophthalmic extended release drug delivery system of the present invention;

FIG. 4B is a top view of another embodiment of a cartridge in an ophthalmic extended release drug delivery system of the present invention;

FIG. 4C is a perspective view of a loading portion of another embodiment of a loader in an ophthalmic extended release drug delivery system of the present invention;

FIG. 5A is a perspective view of a drug delivery assembly of another embodiment of a cartridge in an ophthalmic extended release drug delivery system of the present invention;

FIG. 5B is a top view of another embodiment of a cartridge in an ophthalmic extended release drug delivery system of the present invention;

FIG. 5C is a perspective view of a loading portion of another embodiment of a loader in an ophthalmic extended release drug delivery system of the present invention;

FIG. 6A is a schematic diagram of one embodiment of a loading track in an ophthalmic extended release drug delivery system of the present invention;

Fig. 6B is a schematic view of another embodiment of a loading rail in an ophthalmic extended release drug delivery system of the present invention.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other alternative embodiments, based on the examples of the application, which are available to one of ordinary skill in the art without making any inventive effort, are within the scope of the application.

As shown in fig. 1A to 6B, the present application provides an ophthalmic sustained release drug delivery system including a syringe 100 for implanting a sustained release drug 300 into an eye and a loader 500 for loading the sustained release drug into the syringe 100. It should be appreciated that the slow release drug 300 of the present application is a solid rather than a liquid, generally circular or contoured, tablet, rod, bar or other shaped body that may be received within the needle cannula 30 of the injector 100 for delivery into the eye. The injector 100 can deliver the sustained release drug 300 to a desired site in the eye, such as the anterior chamber, the posterior chamber, and the inside of the retina, subretinal, the choroidal space, etc., where the sustained release drug 300 is continuously released, reducing the frequency of frequent administration, and the patient does not need to frequently use eyedrops or apply ointments due to the long-acting nature of the sustained release drug 300, thereby improving the convenience of treatment and patient compliance.

Embodiments of a bolus 100 and a loading unit 500 in a sustained release drug delivery system according to the present application are described below with reference to fig. 1A-6B.

As shown in fig. 1A to 1K, as an embodiment of the injector 100, the injector 100 includes a housing 10, an ejection button 20, a needle tube 30, and a pushing mechanism 40; wherein the housing 10 forms a handle portion of the injector 100 for convenient handling by an operator; the ejection button 20 is partially exposed out of the casing 10, and an operator can trigger the ejection button 20 in a pressing manner so that the pushing mechanism 40 can longitudinally move in the casing 10, overcome the adhesion force between the slow release medicine 300 and the needle tube 30, and smoothly eject and deliver the slow release medicine 300 in the needle tube 30 into eyes.

Referring to fig. 1A, 1B and 1K, in this embodiment, the housing 10 has a lateral opening 19, the lateral opening 19 is located at the top of the housing 10, the ejection button 20 exposes the housing 10 through the lateral opening 19, and a portion of the ejection button 20 exposed to the housing 10 may be a surface or a part of the ejection button 20, so as to facilitate an operator to trigger the ejection button 20.

As shown in fig. 1D, the ejection button 20 includes a pressing portion 21 and a guiding portion 22, wherein the pressing portion 21 is exposed on the surface of the housing 10, and a groove for increasing friction is formed on the surface of the pressing portion 21, so that the surface friction of the pressing portion 21 is increased, and an operator can press the ejection button conveniently without sliding.

The guide part 22 is connected with the pressing part 21 and is positioned in the shell 10, and in combination with fig. 1C, a stop part 11 is arranged in the shell 10, one end of the guide part 22 is adjacent to the stop part 11, and the stop part 11 is provided with a first guide hole 111; the guide portion 22 has a guide passage 221 in its length direction (i.e., longitudinal direction), and the guide passage 221 includes a second guide hole 222 and a through groove 223 communicating with the second guide hole 222, which together form the guide passage 221. As shown in fig. 1B and 1C, when the ejection button 20 is not triggered, the first guide hole 111 and the second guide hole 222 in the housing 10 are dislocated up and down, and the pushing mechanism 40 is stopped at the guide portion 22 and cannot move longitudinally in the housing 10 through the guide channel 221; after the ejection button 20 is triggered, the first guide hole 111 and the second guide hole 222 in the housing 10 are coaxial, and the pushing mechanism 40 can longitudinally move in the housing 10 through the guide channel 221, so that the sustained release medicine 300 is ejected out of the needle tube 30.

As shown in fig. 1B, in the present embodiment, at least one limit stop 13 is provided in the housing 10, and the limit stop 13 is disposed on a side opposite to the ejector button 20 on the inner wall of the housing 10, so that when the ejector button 20 is displaced into the housing 10 (the displacement direction thereof is perpendicular to the longitudinal direction), the guide portion 22 in the ejector button 20 is stopped against the limit stop 13, thereby limiting the further displacement of the ejector button 20.

As shown in fig. 1D, in some embodiments, in order to make the ejector button 20 have a comfortable pressing feel, the ejector button 20 is in a hollow structure, the second guide hole 222 and the through groove 223 are connected with the cavity inside the ejector button 20 into a whole, at this time, two sides of the guide portion 22 are provided with a first slot 224 and a first deforming arm 225, the first slot 224 is communicated with the cavity inside the guide portion 22, the first deforming arm 225 is disposed in the first slot 224, the shape of the first deforming arm 225 is adapted to that of the first slot 224, the outer side of the first deforming arm 225 is provided with a first protrusion 226 protruding outwards, and correspondingly, as shown in fig. 1H and 1K, the inner wall of the housing 10 is provided with a second protrusion 14 at a corresponding position; when the ejection button 20 is not triggered, the first protrusion 226 is clamped on the second protrusion 14, that is, the second protrusion 14 can prevent the ejection button 20 from moving into the housing 10; the ejector button 20 moves toward the inside of the housing 10 when triggered, the first protrusion 226 is pressed by the second protrusion 14 to deform the first deforming arm 225 toward the inside of the guide portion 22, and at this time, the first protrusion 226 releases the restriction of the second protrusion 14 to follow the displacement of the guide portion 22.

Further, in order to make the first deforming arm 225 deform more easily, the force for displacing the ejection button 20 is avoided from being too large, the first deforming arm 225 is further provided with a pressure reducing hole 227, the pressure reducing hole 227 is close to the connection between the first deforming arm 225 and the first slot 224, and the combination length of the first deforming arm 225 and the first slot 224 is reduced, so that the first deforming arm 225 deforms more easily, and the force required by an operator for triggering the ejection button 20 is reduced.

As shown in fig. 1B, 1C and 1K, the injector 100 further includes a limiting latch 50, the limiting latch 50 penetrates through the housing 10, a latch hole 104 through which the limiting latch 50 penetrates is provided on the housing 10, and when the injector 100 is in the ejection state, the limiting latch 50 is located at the bottom of the guide portion 22 and can limit the displacement of the guide portion 22; that is, the limit latch 50 is provided to prevent the injector 100 from being triggered by mistake, and when in use, the ejection button 20 can be triggered after the limit latch 50 is pulled out, thereby enhancing the safety of the injector 100 during transportation or use.

In this embodiment, the pushing mechanism 40 is disposed in the housing 10, the pushing mechanism 40 includes a push rod 41, an elastic member 42 and a push wire 43, one end of the push wire 43 is connected to the push rod 41, and the elastic member 42 acts on the push rod 41; when the injector 100 is in the state before ejection, the push rod 41 is stopped at the ejection button 20, and when in the ejection state, the push rod 41 enters the guide channel 221 under the elasticity of the elastic piece 42 and drives the push wire 43 to axially move along the needle tube so as to eject the slow release drug 300 from the needle tube 30 by pressing the pressing part 21 so as to enable the ejection button 20 to be displaced into the shell 10.

As shown in fig. 1C, the push rod 41 includes a first stepped shaft 411, a stopper element 412, and a second stepped shaft 413 in the axial direction, wherein one end of the first stepped shaft 411 is inserted into the first guide hole 111; one end of the stopping element 412 is connected to the other end of the first stepped shaft 411, and its cross-sectional size is larger than that of the first guide hole 111, so that it can stop against the first guide hole 111 of the stopping portion 11; one end of the second stepped shaft 413 is connected to the other end of the stopper element 412, and the elastic member 42 acts on the other end of the second stepped shaft 413. When the injector 100 is in the pre-ejection state, the elastic member 42 is in a compressed state, and the first stepped shaft 411 is stopped at the guide portion 22 of the ejection button 20; in the ejection state, the elastic member 42 releases the elastic force, and acts on the second stepped shaft 413 to enable the first stepped shaft 411 to enter the second guide hole 222, so as to push the push wire 43 to move axially along the needle tube 30 and push the slow release drug 300, and when the stop element 412 stops at the first guide hole 111, the first stepped shaft 411 stops moving, the slow release drug 300 is ejected from the needle tube 30, and the injector 100 completes ejection.

In order to improve the stability of the longitudinal movement of the first stepped shaft 411, the pushing mechanism 40 further includes a sliding rod 44, the housing 10 has a fixing portion 12 therein, one end of the sliding rod 44 is fixed to the fixing portion 12, the other end of the second stepped shaft 413 is provided with an axial sliding cavity 4131 along the axial direction, the other end of the sliding rod 44 is inserted into the axial sliding cavity 4131, the sliding rod 44 can provide a guide for the second stepped shaft 413, so as to prevent the second stepped shaft 413 from generating a radial offset during the movement; the elastic member 42 is sleeved on the sliding rod 44, one end of the elastic member 42 abuts against the second stepped shaft 413, the other end abuts against the fixing portion 12, and when the injector 100 is in the pre-ejection state, the second stepped shaft 413 presses the elastic member 42, so that the elastic member 42 is compressed to provide thrust to the second stepped shaft 413 in the ejection state.

As shown in fig. 1C, it is preferable that the fixing portion 12 has a plurality of fixing holes 121, and one end of the slide bar 44 passes through the fixing holes 121 of the plurality of fixing portions 12 and is fixedly coupled with the plurality of fixing portions 12, so that the end stability of the slide bar 44 is enhanced, and the elastic member 42 is located between the second stepped shaft 413 and the fixing portion 12 adjacent to the second stepped shaft 413.

In other embodiments, in order to enhance the protection of the push wire 43 and prevent the push wire 43 from bending during the movement process, the push mechanism 40 further includes a push wire sleeve (not shown) with an inner diameter slightly larger than the outer diameter of the push wire 43, so as to ensure that the push wire can move smoothly in the push wire sleeve, the push wire sleeve is fixedly connected with the first stepped shaft 411, and the other end extends in the axial direction of the push wire 43, or one end of the push wire sleeve is slidably connected with the first stepped shaft 411, and the other end of the push wire sleeve is fixed in the head end 60 of the injector 100.

In other embodiments, the pushing mechanism 40 does not have the slide bar 44, the elastic member 42 is disposed between the second stepped shaft 413 and the fixed portion 12, one end of the elastic member 42 is fixedly connected to the second stepped shaft 413, and the other end of the elastic member 42 is connected to the fixed portion 12. The elastic member 42 provides elastic force to the second stepped shaft 413 after being compressed.

In the present embodiment, the head end of the housing 10 has a head end opening 18, and the injector 100 further includes a head end portion 60 fixed to the head end opening 18, as shown in fig. 1E, the head end portion 60 including an engagement portion 61 and a tapered extension portion 62 in the longitudinal direction. The engaging portion 61 is provided with a first engaging groove 611 along the outer circumferential direction, and the first engaging groove 611 is adapted to the head end opening 18, such that the head end opening 18 of the housing 10 can be engaged into the first engaging groove 611. In other embodiments, head end 60 is integrally formed with housing 10, reducing the number of components of injector 100 as a whole, reducing assembly difficulties and processing requirements.

Further, in the present embodiment, the two opposite sides of the engaging portion 61 are provided with engaging holes 613, as shown in fig. 1K, the inner wall of the housing 10 is provided with fixing blocks 15 combined with the engaging holes 613, and when the head end 60 is mounted, the fixing blocks 15 in the housing 10 can be inserted into the engaging holes 613, so as to further strengthen the fixed connection between the housing 10 and the head end 60, and prevent the head end 60 from being separated from the housing 10.

The conical extension part 62 is in a conical cylinder structure, the cross section size of the conical extension part 62 gradually decreases along the direction away from the clamping part 61, the conical extension part 62 is provided with a fixing cavity along the axial direction, the injector 100 further comprises a needle sleeve 90, the needle sleeve 90 is arranged in a penetrating manner and is fixed in the fixing cavity, the proximal end of the needle tube 30 is fixedly connected with the needle sleeve 90, the distal end of the needle tube 30 extends along the direction away from the shell 10, and the slow release medicine 300 can be accommodated in the needle tube 30.

As shown in fig. 1I and 1J, in order to enhance protection of the needle tube 30, the injector 100 further includes a protective cap 70, the protective cap 70 is connected with the head end 60 in a pluggable manner, the protective cap 70 includes a first cover portion 71 and a second cover portion 72 in a longitudinal direction, two opposite sides of the first cover portion 71 are provided with second slots 711, the first cover portion 71 further includes second deformation arms 712 disposed in the second slots 711, the shape of the second deformation arms 712 is adapted to the second slots 711, a third protrusion 713 is disposed on an inner side of the second deformation arms 712 (i.e., an inner wall of the protective cap 70), in fig. 1E, the engagement portion 61 is further provided with a second clamping groove 612 along an outer circumference, and the third protrusion 713 is capable of being clamped into the second clamping groove 612.

When the protective cap 70 is inserted into the head end 60 in the longitudinal direction, the front end of the engaging portion 61 deforms the second deforming arm 712 by pressing the third protrusion 713, so that the second deforming arm 712 expands outward, the protective cap 70 can further move longitudinally toward the housing 10, and finally the third protrusion 713 engages into the second engaging groove 612 to complete the insertion connection with the head end 60; also, in use of the injector 100, the second deforming arms 712 deform when the protective cap 70 is pulled out of the head end 60, and the protective cap 70 is easily separated from the head end 60.

The second cover part 72 extends in a direction in which the first cover part 71 is away from the head end part 60 so as to adapt to the length of the needle tube 30, and the surface of the second cover part 72 is provided with a slip-preventing protrusion 721 to enhance the surface friction of the second cover part 72, thereby facilitating the insertion and removal of the protective cap 70 by an operator.

As shown in fig. 1F and 1G, in the present embodiment, the needle tube 30 is provided with a working hole 31 in the radial direction at a position near the distal end thereof; the injector 100 further comprises a stopper 80, which is inserted into the working hole 31 to limit the slow release drug 300 from falling out of the distal end of the needle tube 30 in an un-ejected state after being loaded, i.e. before the injector 100 is used, the slow release drug 300 is loaded in the needle tube 30, and the stopper 80 can play a role in stopping the slow release drug 300, so as to prevent the slow release drug 300 from falling out of the distal end of the needle tube 30; when the injector 100 is in the ejection state, the limiting plug 80 needs to be removed, the slow release medicine 300 can be ejected out of the needle tube 30 under the pushing of the push wire 43, and in the ejection process of the slow release medicine 300, the working hole 31 can discharge air in the needle tube 30, so that air in the implantation process is reduced to enter eyes.

As shown in fig. 1K, in the present embodiment, the housing 10 includes a first housing 16 and a second housing 17 that are detachably connected; positioning columns 102 are arranged on the inner walls of the first shell 16 and the second shell 17, a positioning groove is formed in one positioning column 102, a positioning convex column is arranged on the other positioning column 102, and the positioning convex columns can be inserted and fixed in the positioning grooves so as to realize the connection of the first shell 16 and the second shell 17; the outer walls of the first shell 16 and the second shell 17 are also provided with anti-slip grooves 105, and the anti-slip grooves 105 are adjacent to the ejection buttons 20, so that the friction force of an operator for holding the handle part is enhanced.

In addition, the housing 10 in the present embodiment is equally divided into the first housing 16 and the second housing 17 on the left and right sides in the vertical direction, and the stopper 11, the first guide hole 111, the limit stopper 13, the head end opening 18, and the lateral opening 19 in the present embodiment are equally divided into symmetrical two parts.

It can be seen that the injector 100 in this embodiment adopts a push button structure, which can make the pushing mechanism 40 move longitudinally in the housing 10, and overcomes the adhesion force between the slow release drug 300 and the needle tube 30 by the axial movement of the push wire 43 in the needle tube 30, so as to smoothly eject and deliver the slow release drug 300 in the needle tube 30 into the eye; the injector 100 has simple integral structure, convenient use, rapid implantation process of the slow release drug 300 and short learning curve of operators; and the distal end of the needle tube 30 is provided with a working hole 31, and the slow-release medicine 300 can be placed in the needle tube 30 by matching with the limit plug 80, so that the working hole 31 can discharge air in the needle tube 30 in the ejection process of the slow-release medicine 300, and the air entering the eye in the implantation process is reduced. The injector 100 in this embodiment is a disposable medical device, i.e. the injector 100 ejects the slow release drug 300 and then is not used any more, so that cross infection can be avoided and the workload of cleaning and disinfection can be reduced.

However, in another embodiment of the present application, as shown in fig. 2A and 2B, unlike the embodiment shown in fig. 1A to 1K, the housing 10 is provided with a reset chute 101, the pushing mechanism 40 further includes a reset lever 45, a fixed end of the reset lever 45 is connected to the push rod 41, a free end passes through the reset chute 101, and the reset lever 45 can move along the reset chute 101; a reset hole 103 is formed in the housing 10 at a position corresponding to the bottom of the guide portion 22. In this embodiment, after the injector completes one ejection, the push rod 41 can be pushed back to the initial position by the reset rod 45, and then the ejector pin passes through the reset hole 103 to abut against the guide portion 22, so that the guide portion 22 returns to the initial position, and the pressing portion 21 exposes out of the housing 10, thereby satisfying multiple uses of the injector 100, and being particularly suitable for proofing or testing scenes.

Further, in other embodiments, a reset member with elastic restoring force is further provided between the bottom of the guiding portion 22 and the limit stop 13, and when the injector 100 completes one ejection, the push rod 41 can be pushed back to the initial position by the reset rod 45, and the ejection button 20 automatically returns under the elastic force of the reset member, so that the repeated use is satisfied.

The foregoing describes various embodiments of a bolus device 100, and various embodiments of a loader 500 in a delivery system according to the present application are described below with reference to FIGS. 3A-6B.

As shown in fig. 3A to 3F, as an embodiment of the loader 500, the loader 500 includes a carrier assembly 510 and a drug delivery assembly 520, wherein the carrier assembly 510 is used for carrying the injector 100, and the drug delivery assembly 520 is used for loading the slow release drug into the needle tube 30 of the injector 100; the drug delivery assembly 520 is in sliding fit with the drug delivery assembly 510 in the longitudinal direction, so that the drug delivery assembly 510 and the drug delivery assembly 520 can be far away from or close to each other; when the injector 100 is fixed on the carrier assembly 510, the drug delivery assembly 520 and the carrier assembly 510 slide relatively so that the injector 100 approaches the drug delivery assembly 520, and after the injector 100 moves in place, the slow release drug is filled into the needle tube 30 through the drug delivery assembly 520; after loading of drug delivery assembly 520 and carrier assembly 510 are separated from each other, and bolus 100 is removed from carrier assembly 510.

As shown in fig. 3B, the carrier assembly 510 includes a stage 511, a carrier cavity 5112 is provided at the top of the stage 511, and the carrier cavity 5112 is shaped to fit the injector 100, such that the injector 100 can be accommodated and fixed in the carrier cavity 5112; the top of the objective table 511 is further provided with a pick-and-place groove 5113 and an avoidance groove 5114, which are communicated with the object carrying cavity 5112, the pick-and-place groove 5113 is used for conveniently picking and placing the injector 100, and the avoidance groove 5114 is used for providing an avoidance space for the limit plug 50 in the injector 100.

Further, the stage 511 further has a sliding cavity 5111, and the sliding cavity 5111 is disposed at the center or bottom of the stage 511 along the longitudinal direction, and the stage 511 is slidably engaged with the drug delivery assembly 520 through the sliding cavity 5111.

As shown in fig. 3C to 3F, in the present embodiment, the drug delivery assembly 520 includes a loading base 521, a pushing member 522, and a top thread 523, wherein the loading base 521 has a loading portion 5210 adjacent to the carrier assembly 510, the loading portion 5210 being for providing a loading space for the sustained release drug 300 and the needle cannula 30, and the loading portion 5210 being capable of restricting the needle cannula 30 and aligning the sustained release drug with the needle cannula 30 when the loader 500 loads the sustained release drug into the injector 100; the pushing member 522 is slidably engaged with the loading seat 521 in the longitudinal direction, one end of the jackscrew 523 is fixedly connected with the pushing member 522, and the other end of the jackscrew 523 can act on the slow release drug, so that the slow release drug can be pushed into the needle tube 30 when the pushing member 522 slides along the longitudinal direction of the loading seat 521 and pushes the slow release drug.

In this embodiment, the loading portion 5210 has a limiting groove 5211 and a positioning hole 5212, the limiting groove 5211 is used for limiting the position of the needle tube 30, the positioning hole 5212 is used for positioning the jackscrew 523, and the central axis of the jackscrew 523, the central axis of the positioning hole 5212 and the central axis of the needle tube 30 are coaxial, so that the jackscrew 523 can push the slow-release drug into the needle tube 30 smoothly and accurately.

As shown in fig. 3E, when the slow release medicine is pushed, the slow release medicine is placed at the bevel of the needle tip of the needle tube 30 under a microscope, then the pushing piece 522 is moved, the slow release medicine is pushed into the needle tube 30 through the jackscrew 523, the slow release medicine is positioned at the inner side (one side close to the handle of the injector 100) of the working hole 31 on the needle tube 30 when being pushed in place, and then the limiting plug 80 is inserted into the working hole 31 on the needle tube 30, so that the slow release medicine is prevented from falling out of the needle tube 30; and then the carrier assembly 510 and the drug delivery assembly 520 are separated from each other, and the injector 100 is taken out.

As shown in fig. 3F, further, the loading portion 5210 is provided with at least one lateral rib 5213 at intervals in the longitudinal direction, and the positioning holes 5212 penetrate the lateral rib 5213.

As shown in fig. 3C, further, a supporting and positioning member 530 is further disposed between the loading portion 5210 and the carrier assembly 510, the supporting and positioning member 530 has a positioning and supporting hole 531, the needle tube 30 passes through the positioning and supporting hole 531, the positioning and supporting hole 531 not only can support the needle tube 30, but also plays a role in limiting the needle tube 30, so as to prevent the needle tube 30 from moving and tilting, and the bevel mouth of the needle tip of the needle tube cannot accurately enter the limiting groove 5211.

Further, as shown in fig. 3D, the loading base 521 includes a loading base 5217 and a loading top base 5218, the loading base 5217 has a longitudinal length greater than that of the loading top base 5218, and the loading top base 5218 is disposed on the loading base 5217 and is detachably connected to or integrally formed with the loading base 5217; the loading portion 5210 is disposed on the loading base 5218, and the loading base 5217 is slidably engaged with the slide cavity 5111, thereby allowing relative sliding movement between the carrier assembly 510 and the drug delivery assembly 520.

In the present embodiment, the loading top base 5218 has a mounting groove 5219 thereon, and the loading portion 5210 is replaceably secured within the mounting groove 5219; so that different loading parts 5210 can be correspondingly replaced in the mounting groove 5219 according to different medicine shapes and needle tube 30 structures of the injector 100, the application range of the loader 500 is improved, the loading parts 5210 are worn after long-term use, and the replacement is also beneficial to later maintenance and replacement; however, in other embodiments, the loading portion 5210 and the loading hub 5218 may be integrally formed for ease of handling, and the drug delivery assembly 520 may be integrally replaced when needed for replacement for different drugs.

As shown in fig. 3C and 3D, the loading knob 5218 has a push guide thereon to enable the push member 522 to slidably engage with the loading knob 5218 in the longitudinal direction, the push guide may be a slide groove 5220 as shown in fig. 3C, the slide groove 5220 is in communication with the mounting groove 5219, and in other embodiments, the slide groove 5220 may be replaced with a slide rail, a slide tube, or other components having a guiding function.

Further, to avoid limiting the travel of the pusher 522, the drug delivery assembly 520 further includes a stopper 526, wherein the stopper 526 is laterally inserted into the chute 5220 for limiting the movement of the pusher 522; it can be seen that one end of the pushing member 522 is stopped by the stopper 526, the other end is stopped by the loading portion 5210, and the slow release drug can be smoothly pushed to the inner side of the working hole 31 on the needle tube 30 during the process of moving the pushing member 522 from the stopper 526 to the loading portion 5210.

In other embodiments, as shown in fig. 4A to 4C, the loading portion 5210 has a limiting groove 5211 and a positioning groove 5214, the limiting groove 5211 is used for limiting the position of the needle tube 30, the positioning groove 5214 is used for accommodating the slow-release drug and positioning the jackscrew 523, and since the needle tube 30 has a certain wall thickness, the depth of the limiting groove 5211 is set to be slightly larger than the depth of the positioning groove 5214, so that the central axis of the jackscrew 523 is coaxial with the central axis of the needle tube 30, and the slow-release drug can be smoothly and accurately pushed into the needle tube 30.

In this embodiment, the drug delivery assembly 520 further includes a cover plate 525, the shape of the cover plate 525 is adapted to the loading portion 5210, so as to cover the loading portion 5210, a positioning protrusion 5251 adapted to the positioning groove 5214 is provided at the bottom of the cover plate 525, and the positioning protrusion 5251 is inserted into the positioning groove 5214, so as to prevent the ejection of the sustained-release drug from the positioning groove 5214 by the jackscrew 523 during the process of pushing the sustained-release drug.

In the present embodiment, the loading seat 521 has a limiting hole 5215 in the longitudinal direction, the limiting hole 5215 is adjacent to the carrier assembly 510 for limiting the needle tube 30, the central axis of the needle tube 30 is coaxial with the central axis of the limiting hole 5215, and the limiting hole 5215 is in communication with the limiting groove 5211 in the longitudinal direction.

In the above-described embodiments of the present application, the loader 500 may also be used by an operator to pre-load a sustained release drug into the injector 100 of the delivery system at the time of use and then deliver the sustained release drug into the eyes of the patient using the injector 100 when the patient is treated; however, for sustained release drugs with a longer controlled release period (e.g., 3 months, 6 months, or 1 year), the drug is usually loaded in the delivery device by the loader 500 before delivery, and more particularly, the drug can be sold together with the delivery device (e.g., the injector 100) after being packaged in a sealed manner by the loader 500 of the following embodiment.

In other embodiments, as shown in fig. 5A to 5C, unlike the embodiments shown in fig. 4A to 4C, the loading portion 5210 further has a drug delivery slot 5216, and the drug delivery slot 5216 is perpendicular to the positioning slot 5214 and is in communication with the positioning slot 5214 for accommodating the sustained release drug 300; the drug delivery assembly 520 further includes a lateral rod 524, wherein the lateral rod 524 acts on the drug delivery device 300 to push the drug delivery device 300 from the drug delivery slot 5216 into the positioning slot 5214.

In this embodiment, a plurality of slow release drugs are arranged in the drug delivery groove 5216, and the lateral rod 524 pushes one slow release drug into the positioning groove 5214 each time, so that after the loading of the injector 100 is completed once, the lateral rod 524 pushes one slow release drug into the positioning groove 5214 again, and the loading of the next injector 100 is performed.

Further, the drug delivery assembly 520 further includes a lateral driving unit, and the lateral pushing unit acts on the lateral rod 524, so as to provide thrust for the lateral rod 524, and automatically push the slow release drug into the positioning groove 5214, so that automatic release of the slow release drug before loading and pushing can be realized.

In some embodiments, to accurately identify whether the needle cannula 30 is moving in place, the loader 500 further includes an in-place detection sensor disposed in the limit slot 5211, which detects whether the needle tip of the needle cannula 30 is moving in place, and if the needle tip of the needle cannula 30 is moving in place, the sliding between the carrier assembly 510 and the drug delivery assembly 520 is stopped, at which time the slow release drug can be loaded into the needle cannula 30.

In some embodiments, after the injector 100 is loaded with the slow release drug, to detect the presence of the slow release drug within the needle cannula 30; the side of the stopper 80 of the injector 100 (the side near the handle of the injector 100 after insertion) is also provided with a detection sensor, after the push wire 523 of the loader 500 pushes the slow release drug, the insertion of the stopper 80 can determine whether the slow release drug exists in the needle tube 30 and is located inside the working hole 31, and if the slow release drug is not detected, the stopper 80 needs to be removed for reloading.

As shown in fig. 6 a-6 b, the sustained release ophthalmic drug delivery system further includes a loading track 600, wherein one of the loading assembly 510 and the drug delivery assembly 520 has a power source, so that the loading assembly 510 and the drug delivery assembly 520 can automatically approach or depart from the loading track 600.

In some embodiments, as shown in fig. 6A, taking the carrier assembly 510 with a power source as an example, the carrier assembly 510 further includes a driving unit, and the driving unit may drive the carrier assembly 510 to move along the loading track 600 to approach the drug delivery assembly 520 for loading the slow release drug or to be away from the drug delivery assembly 520 after loading the slow release drug.

In some embodiments, as shown in fig. 6B, the loading track 600 includes at least a first loading track 610 and a second loading track 620, and the loader 500 has at least two carrier assemblies 510, each carrier assembly 510 selectively passing through the first loading track 610 or the second loading track 620, such that the loading of the slow release drug can be alternately performed by the at least two carrier assemblies 510, thereby improving the loading efficiency of the loader 500.

In some embodiments, the drug delivery assembly 520 further includes a longitudinal pushing mechanism, where the longitudinal pushing mechanism acts on the pushing member 522, and is capable of providing a pushing force to the pushing member 522 when the sustained release drug loading system detects that the needle tube 30 of the injector 100 is in place and the sustained release drug is in place, so as to automatically push the sustained release drug, where the in-place delivery of the sustained release drug can be detected by a sensor mounted on the side of the limit groove 5211 or by providing a probe on the loading seat 521, and detecting by imaging.

In some embodiments, the carrier assembly 510 or the drug delivery assembly 520 of the loader 500 further has a locking member (not shown), where the locking member locks the carrier assembly 510 and the drug delivery assembly 520 to prevent the carrier assembly 510 and the drug delivery assembly 520 from moving relative to each other and the pushing member 522 of the drug delivery assembly 520 cannot accurately load the sustained release drug at the designated position of the needle tube 30 before the carrier assembly 510 and the drug delivery assembly 520 approach each other to prepare for loading the sustained release drug.

In some embodiments, for the loader 500 shown in fig. 3A to 4C, the ophthalmic sustained-release drug delivery system also includes a control unit and a drug delivery manipulator, where the control unit is electrically connected to the driving unit, the drug delivery manipulator, and the longitudinal pushing mechanism, where the control unit can control the driving unit to drive the drug carrying component 510 and the drug delivery component 520 to approach or depart from each other, can control the drug delivery manipulator to automatically deliver and place the sustained-release drug into the bevel incision position of the needle tube 30 or the positioning slot 5214, and can control the longitudinal pushing mechanism to automatically push the sustained-release drug into the needle tube 30, so as to realize loading of the sustained-release drug by the injector 100 in a fully-automatic manner.

In some embodiments, for the loader 500 shown in fig. 5A to 5C, the ophthalmic sustained-release drug delivery system further includes a control unit, where the control unit is electrically connected to the driving unit, the lateral driving unit, and the longitudinal pushing mechanism, where the control unit can control the driving unit to drive the loading component 510 and the drug delivery component 520 to approach or depart from each other, can control the lateral driving unit to automatically deliver the sustained-release drug into the positioning groove 5214, and can control the longitudinal pushing mechanism to automatically push the sustained-release drug into the needle tube 30, so that the injector 100 loads the sustained-release drug in a fully automatic manner, and improves the production and processing efficiency.

Finally, it should be noted that, if directional indications (such as up, down, left, right, front, and rear … …) are included in the embodiments of the present application, the directional indications are merely used to explain the relative positional relationship, movement, etc. between the components in a specific gesture (as shown in the drawings), and if the specific gesture changes, the directional indications correspondingly change.

In addition, if there is a description of "first", "second", etc. in the embodiments of the present application, the description of "first", "second", etc. is for descriptive purposes only and is not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In addition, the technical solutions of the embodiments may be combined with each other, but it is necessary to base that the technical solutions can be realized by those skilled in the art, and when the technical solutions are contradictory or cannot be realized, the combination of the technical solutions should be considered to be absent and not within the scope of protection claimed in the present application.

The foregoing is only the embodiments of the present application, and therefore, the patent scope of the application is not limited thereto, and all equivalent structures or equivalent processes using the descriptions of the present application and the accompanying drawings, or direct or indirect application in other related technical fields, are included in the scope of the application.

Claims

1. An ophthalmic sustained release drug delivery system comprising:

a bolus for implanting a sustained release drug into an eye, comprising:

A housing forming a handle portion of the injector;

The ejection button is partially exposed out of the shell; the ejection button comprises a pressing part and a guide part, wherein the pressing part is exposed out of the surface of the shell, and the guide part is provided with a longitudinal guide channel;

A needle cannula fixed to the head end of the handle portion, the needle cannula insertable into an eye and containing the slow release drug therein;

The pushing mechanism is arranged in the shell and can act on the slow-release medicine, and can longitudinally move in the shell after being triggered by the ejection button so as to eject the slow-release medicine into eyes; the pushing mechanism comprises a push rod, an elastic piece and a pushing wire, one end of the pushing wire is connected with the push rod, the other end of the pushing wire acts on the slow release medicine, and the elastic piece acts on the push rod; when the injector is in a state before ejection, the push rod is stopped at the ejection button, and when the injector is in an ejection state, the push rod is pressed to enable the ejection button to move into the shell, and the push rod enters the guide channel under the elasticity of the elastic piece and drives the push wire to move so as to eject the slow-release medicine from the needle tube;

A loader for loading a slow release drug into the bolus comprising:

The carrying assembly is used for carrying and fixing the injector;

the medicine delivery assembly is in relative sliding fit with the medicine carrying assembly in the longitudinal direction, so that the medicine carrying assembly and the medicine delivery assembly can be far away from or close to each other, and the medicine delivery assembly is used for loading slow release medicine into the needle tube; the drug delivery assembly includes:

a loading bay having a loading portion adjacent the carrier assembly, the loading portion for providing a loading space for the slow release drug and the needle cannula;

the pushing piece is in sliding fit with the loading seat in the longitudinal direction;

And one end of the jackscrew is fixedly connected with the pushing piece, and the other end of the jackscrew can act on the slow-release medicine so as to drive the jackscrew to push the slow-release medicine into the needle tube when the pushing piece is allowed to move along the longitudinal direction of the loading seat.

2. The extended release ophthalmic drug delivery system of claim 1, wherein at least one positive stop is provided in the housing such that the guide portion stops against the positive stop when the ejection button is displaced into the housing.

3. The extended release ophthalmic drug delivery system of claim 1, wherein both sides of the guide portion have first slots; the guide part is further provided with a first deformation arm arranged in the first slot, the shape of the first deformation arm is matched with that of the first slot, a first protrusion is arranged on the outer side of the first deformation arm, a second protrusion is arranged on the inner wall of the shell, and the first protrusion can be clamped with the second protrusion.

4. The ophthalmic extended release drug delivery system of claim 1, wherein the needle cannula is provided with a working hole in a radial direction near its distal end, the injector further comprising a limiting plunger inserted into the working hole to limit the release drug from falling off the distal end of the needle cannula when not ejected after loading, the limiting plunger being removed in an ejected state, the working hole being used to expel air from within the needle cannula.

5. The ophthalmic sustained release drug delivery system of any one of claims 1 to 4, wherein the loading portion has a limit groove for limiting the position of the needle cannula and a positioning hole for positioning the jackscrew, the central axis of the positioning hole, and the central axis of the needle cannula being coaxial.

6. The extended release ophthalmic drug delivery system of claim 5, wherein the loading base has a mounting slot therein, the loading portion is replaceably secured within the mounting slot, the loading portion is provided with at least one lateral rib spaced apart in a longitudinal direction, and the positioning hole extends through the lateral rib.

7. The extended release ophthalmic drug delivery system of claim 1, wherein the carrier assembly comprises a stage having a sliding cavity;

the loading seat comprises a loading base and a loading top seat, the loading part is positioned on the loading top seat, and the loading base is in sliding fit with the sliding cavity.

8. The ophthalmic extended release drug delivery system of claim 7, further comprising a loading rail, wherein the carrier assembly further comprises a drive unit that can drive the carrier assembly along the loading rail to move closer to the drug delivery assembly for loading of the extended release drug or away after loading of the extended release drug.

9. The extended release ophthalmic drug delivery system of claim 7, wherein a top of the stage is provided with a cargo cavity along a longitudinal direction that is adapted to the bolus such that the bolus is receivable and securable within the cargo cavity.