KR20210095385A - An apparatus for ocular injection and an apparatus for delivering substance - Google Patents

Abstract

The present invention relates to an ocular material delivery device. The ocular material delivery device comprises: a body having an accommodating unit for accommodating a delivery material therein, wherein a needle is installed at one end of the body; a movable member installed to move forward and backward along the inside of the body so as to deliver the delivery material to a treatment site through the needle; and a light path unit disposed along the longitudinal direction of the body or the movable member and including a light path unit forming a path through which light delivered from an external light source is irradiated to an end of the needle.

Description

AN APPARATUS FOR OCULAR INJECTION AND AN APPARATUS FOR DELIVERING SUBSTANCE

The present invention relates to an ocular injection device and a substance delivery device, and more particularly, to an ocular injection device and a substance delivery device for delivering a substance into the body after inserting and positioning a needle into the body.

Many fatal eye diseases are caused by lesions of the retina located inside the eyeball. Examples of such eye diseases include age-related macular degeneration (AMD), diabetic retinopathy (DR), retinal vein occlusion (BRVO), and hereditary retinal disease.

However, since physicochemical barriers including BRB (Blood-Retina-Barrier) exist in the retina, the drug does not effectively reach the retinal tissue by using a topical drug in the form of eye drops or by systemic administration through oral or vascular injection. Therefore, in order to treat these lesions, it is most effective to directly inject a therapeutic substance by penetrating the eye and inserting a needle into the eye. An ocular injection device used for such treatment is also disclosed in Korean Patent Application Laid-Open No. 10-2013-0059577.

As described above, the ocular injection device delivers a therapeutic substance into the eyeball while being inserted into the eyeball through the sclera of the eyeball. At this time, it is preferable to deliver the drug in a state that the needle end of the injection device is positioned in the vitreous cavity in the eye.

However, the conventional injection device for the eye has a problem in that it is difficult to accurately determine the position of the needle when the needle is inserted. Therefore, in a state in which the needle is not inserted to a sufficient depth, the therapeutic material cannot be delivered to the retina, and thus a sufficient therapeutic effect cannot be seen. This problem is not limited to the injection device for the eye, and the injection device used for tissues other than the eye has a similar problem.

Patent Publication No. 10-2013-0059577

An object of the present invention is to provide an ocular injection device and a material delivery device that can easily determine the position of the end of the needle while the needle is inserted into the body.

In order to achieve the above object, the present specification, a body having a needle installed at one end and a receiving part in which a delivery material is accommodated therein, advances and retreats along the inside of the body so that the delivery material can be delivered to the treatment site through the needle Provided is an ocular material delivery device comprising a movable member that is operably installed, and a light path part disposed along the length direction of the body or the movable member and forming a path through which light transmitted from an external light source is irradiated to the needle end do.

Here, the light path part may be insertedly installed inside the movable member to be movable according to the forward/backward movement of the movable member. Alternatively, the light path part is provided on a separate path provided on the inside of the body or the movable member, and the end of the optical path part is fixed at a position adjacent to the end of the needle while the movable member moves forward and backward. can be configured to maintain.

On the other hand, it may further include a detection unit for obtaining the position information of the needle end by detecting that the light irradiated to the end of the needle is reflected from the inside of the eyeball and received by the light path unit. And, when it is detected that the needle end is located at a predetermined distance from the fundus by the detection unit, it may further include a notification unit for notifying the user.

According to the present invention, since it is possible to check the position of the end of the needle when inserting the needle into the body to deliver and collect the substance, it is possible to improve the therapeutic effect by delivering the substance to the desired position, or to collect the desired substance. it is possible

In addition, since it is possible to adjust the insertion direction and insertion depth while checking the position of the needle end, there is an advantage in that it is possible to prevent the risk of damage to the body tissue by the needle end.

1 is a view showing the structure of an ocular mass transfer device according to a first embodiment;
2 is a view showing the structure of an ocular mass transfer device according to a second embodiment;
3 is a view showing the structure of an ocular mass delivery device according to a third embodiment;
4 is a view showing the propagation path of light irradiated through the light path unit,
5 is a diagram illustrating a state in which a therapeutic substance is delivered into the eyeball using the above-described injection device.

Hereinafter, with reference to the drawings, it will be described in detail for the eye irradiation device according to an embodiment of the present invention. In the following description, the positional relationship of each component will be described based on the drawings in principle. The drawings may simplify the structure of the invention for convenience of description or may be exaggerated if necessary. Therefore, the present invention is not limited thereto, and it goes without saying that various devices may be added, changed, or omitted.

Here, the 'injection' device means a device that includes a needle having a sharp end and can perform a treatment action while the needle is inserted into the body. Such an injection device is generally used as a mass delivery device for delivering a therapeutic substance into the body, but may also be included when used for collecting substances such as body fluid from the body.

In addition, the term 'therapeutic material' refers to a material used for the purpose of treating lesions, and may include various materials such as stem cells and genetic materials as well as commonly used drugs.

In the following examples, the injection device inserted into the eye will be mainly described, but the present invention is not limited thereto. It may include injection devices inserted into various body parts other than the eyeball, and may also include various injection devices used to treat mammals including humans.

Hereinafter, an ocular mass delivery device according to an embodiment of the present invention will be described with reference to FIG. 1 . 1 is a diagram illustrating the structure of an ocular mass delivery device according to a first embodiment.

The ocular material delivery device 10 includes a body 200 and an injection device 100 connected to the body. As shown in FIG. 1 , the main body 200 includes a light source 210 , a detection unit 220 , and a notification unit 230 . In addition, the injection device 100 includes a housing 110, a needle unit 120 provided at one end of the housing, a movable member 130 slidably inserted inside the housing, and an optical path unit for irradiating light to the end of the needle unit. (300) is included.

First, the housing 110 is configured in a cylindrical structure to constitute the body of the injection device (100). A cylindrical inner space in the longitudinal direction is provided therein to form the accommodating part 111 in which the material is accommodated. The material stored in the receiving unit 111 may be a delivery material intended to be delivered into the eye when a therapeutic material is delivered, or may be a body material collected from the eye when collecting intraocular body fluid. The housing 110 is made of a transparent material so that the amount of the material accommodated therein and the position of the movable member can be confirmed, and a scale (not shown) for quantitatively confirming this may be displayed on the outside.

A fixing part 112 to which the needle part 120 is installed is installed at one end of the housing. The fixing part 112 is configured in a protrusion shape so that the needle part 120 can be fitted, and a hollow through which a material can pass is formed in the middle. An opening into which the movable member 130 is inserted is formed at the other end of the housing. A finger rest 113 having a wing structure extending outwardly is formed in a portion adjacent to the opening. The user may advance and retreat the movable member using the finger rest.

Meanwhile, the needle part 120 is configured to include a hub 121 and a needle 122 . The hub 121 is provided at the rear end of the needle part 120 , and fitted to the aforementioned fixing part 112 , whereby the needle part 120 is detachably installed in the housing 110 . The needle 122 is a part to be inserted into the body and is made of a hard material, and a hollow through which the material can pass is formed therein.

The injection device according to this embodiment has a needle length of 20 mm or more so that a substance can be injected onto the posterior vitreous in a state in which the needle end is close to the retina while the needle is inserted into the eyeball, and specifically It may have a length of 20 to 26 mm. And, the end of the needle 122 may be configured in a pointed structure having an angle of 60 degrees or less at the end of the needle end to facilitate insertion into the body.

And, the movable member 130 is configured to include a shaft 131 forming a body and a packing portion 133 provided at the front end of the shaft. The shaft 131 is formed to extend along the longitudinal direction of the housing, and is configured to be inserted into the housing through the rear opening of the housing. The shaft 131 is configured to move forward and backward along a path formed inside the housing by a user's manipulation or driving of a separately provided driving unit. The shaft 131 according to this embodiment, as shown in FIG. 1, is provided with a pressing part 132 in the form of an outward extension at the rear end, and the user presses or pulls the pressing part 132 to move it. A forward/backward movement of the member 130 is performed. The aforementioned packing part 133 is made of a material having elasticity, such as rubber, and is provided at the front end of the shaft 131 . The packing part 133 partitions the rear side of the receiving part of the housing, and serves to seal between the movable member 130 and the inner wall of the housing 110 . Thereby, the rear side of the accommodating part can maintain airtightness even when the movable member moves forward and backward.

This injection device 100 may suck the material by the advance and retreat of the movable member 130, or may discharge the material inside the receiving unit to the outside. Specifically, when the movable member 130 is retracted while the end of the needle 122 is immersed in the container in which the delivery material is accommodated, the therapeutic material is introduced into the receiving part through the needle 122 end and is accommodated. Then, when the movable member 130 is advanced while the needle 122 is inserted into the eyeball, the therapeutic material accommodated in the receiving part 111 is delivered to the inside of the eyeball through the needle end.

This eye injection device 100 can be used to deliver a therapeutic material for the treatment of retinal lesions. Specifically, when a therapeutic substance is injected with the needle 122 end of the injection device positioned in the vitreous cavity, the therapeutic substance diffuses inside the vitreous (since it is injected into the posterior vitreous in proximity to the retina, the drug does not directly contact the retina) The expression “diffusion” can damage the value of the patent, and it is considered to be the same as the existing injection needle, so the patent will be rejected.) It is transmitted to the retina for treatment. However, if the insertion depth of the needle is not sufficient, there is a problem that the therapeutic material is not properly delivered to the retina, and if the insertion depth of the needle is too deep, there is a risk of physical damage to the retinal tissue. In order to overcome such a problem, a reporting light source through a separate eye perforation must be inserted into the eye, and the position of the needle can be checked using a surgical microscope and an auxiliary lens system. However, there is a disadvantage that is accompanied by the risk of retinal detachment and endophthalmitis according to the process of eye perforation for light source insertion and intraocular insertion of an auxiliary light source.

Accordingly, the present invention may be configured to be provided with the optical path unit 300 in the scanning device 100 so as to overcome this problem. The optical path unit 300 is configured to allow light to travel along an internal path, such as an optical fiber. One end of the light path unit 300 may be connected to the light source 210 of the main body 200 provided outside the injection device, and the other end may be disposed to be inserted into the needle 122 . Accordingly, the light path unit 300 forms a light path through which the light transmitted from the external light source 210 is irradiated to the end of the needle 122 . At this time, since the outer wall of the needle 122 is made of a material that does not transmit light, it is possible to confirm the position of the needle end to the position where the light is irradiated. In particular, in a state in which the needle end is inserted into the body, light emitted through the needle end is scattered by the body fluid or tissue in an adjacent position. In particular, when proceeding to a transparent or translucent tissue such as an eyeball, it is possible to easily grasp the position of the needle end using the light emitted through the needle 122 end.

Specifically, as shown in FIG. 1 , a hollow 134 is formed inside the movable member 130 , and the light path part 300 selectively moves into the movable member 130 through the hollow 134 . is inserted The diameter of the light path portion 300 is smaller than the diameter of the hollow 134 of the movable member and the inner path of the needle 122 . The light path part 300 is inserted so that the end protrudes in front of the packing part 133 of the movable member and is positioned inside the needle. Accordingly, in a state in which the optical path unit 300 is located inside the needle, it is possible to receive the material through the needle into the receiving unit or to inject the material into the eyeball.

At this time, the optical path part 300 is inserted into the hollow 134 of the movable member in a state in which the movable member is advanced as far as possible in the needle direction, and the end of the optical path part 300 does not protrude outside the end of the needle 122 . However, it is inserted so as to be positioned adjacent to the needle end. Accordingly, the optical path portion may not protrude outside the needle while performing the intraocular substance injection operation using the injection device.

An O-ring-shaped sealing part 135 is provided at an end of the hollow 134 on the side of the packing part. The sealing unit 135 may fix the position of the light path unit 300 as long as a separate external force is not applied by the user while the light path unit 300 is inserted into the hollow. Accordingly, the light path unit 300 of FIG. 1 may move integrally according to the forward/backward motion of the movable member 130 . Furthermore, the sealing part 135 may block the space between the hollow 134 and the accommodating part 111 to block the material accommodated in the accommodating part from flowing into the movable member.

However, in a state in which the light path unit 300 is inserted into the movable member, the light path unit may be detached from the needle unit as the movable member moves backward to accommodate the material. Therefore, a separate limiting part (not shown, for example, a protrusion structure such as a locking jaw) may be provided to limit the distance of the moving member's retreating operation, or the limiting distance of the light path part may be detached from the needle. may be formed on the outer surface of the housing using a separate mark (not shown). In this case, the limited retraction operation distance or the limit retraction distance may be shorter than the length of the needle.

Meanwhile, the main body includes a light source 210 , a detector 220 , and a notification unit 230 , and includes a separate control unit (not shown) for controlling their operations. However, hereinafter, the light source and its control operation will be mainly described, and the configuration of the detection unit and the notification unit will be described using separate drawings below.

The light source 210 generates light and transmits the light through the light path unit 300 . Therefore, the transmitted light may be irradiated to the outside through the end of the needle (122). In this case, the light source 210 generates light having a wavelength of the visible light band, and the user can check the light emitted through the needle end. (It is not important to check the emitted light. It is meaningless to visually check the emitted light source. In the end, it is necessary to observe that a precise distance between the retina and the needle, that is, a 1-2 mm gap, is observed, so that a very clear image is obtained. It is necessary to observe through a microscope. The position of the needle and the intraocular environment including the retina can be directly observed through the light emitted from the light source, so the needle can be positioned at a desired position.) The light source 210 is the surface of the tissue It is possible to generate light of a good wavelength reflected from the light, and it can be configured to irradiate light of a single wavelength or a combination of light of a plurality of wavelengths. Alternatively, it is also possible to provide a plurality of light source modules capable of generating light of different wavelengths to selectively change the wavelength of the irradiated light. Such a light source may be configured using various types of light sources such as LED, LD, laser oscillator, and flash lamp.

Meanwhile, the controller may be configured to control the light source 210 to control brightness, on/off operation, blinking, color, etc. of the light source during a mass transfer procedure. Therefore, the brightness, blinking pattern or wavelength of the light emitted to the needle end during the operation of inserting the needle, the operation of displaying the position of the needle end to the user, the operation of measuring the distance between the needle end and the tissue, or the operation of injecting a substance is different It is also possible to control

The embodiment of FIG. 1 described above has a structure in which an optical path for transmitting light provided from the outside is provided, and the optical path part moves along with the forward/backward operation of the movable member of the scanning device. However, the present invention is not limited to the embodiment of FIG. 1 , and the optical path unit may be configured to maintain a fixed position even while the movable member moves forward and backward. Hereinafter, an embodiment different from that of FIG. 1 will be described with reference to FIGS. 2 and 3 . However, the same names and reference numerals are given to components corresponding to those of the embodiment of FIG. 1 , and descriptions of the corresponding components and features thereof are omitted in order to avoid duplication of description.

2 is a diagram illustrating the structure of an ocular mass delivery device according to a second embodiment. In the embodiment shown in FIG. 2 , the injection device 100 may further include a separate fixing member 140 for selectively fixing the position of the light transmitting member. In this case, the fixing member 140 may be configured to fix the position by selectively pressing the outer surface of the optical path part 300 by the user's manipulation from the outside of the housing or the needle part.

As an example, the fixing member 140 shown in FIG. 2 is provided in the form of a button on the outside of the front end of the housing 110 , and when the user presses the fixing member 140 , the position of the fixing member moves in the inner direction of the housing, and the light It is configured to press the outside of the path portion in at least two directions. However, the structure of the fixing member is an example, and in addition to this, as the user rotates the fixing member including the screw thread structure from the outside of the housing or the needle part, the inner diameter is reduced while pressing the outside of the optical path part in various ways, such as a method. It may be configured to fix the optical path unit. At this time, the fixing member is configured to include a movement path such as an opening so that the material can move between the receiving portion and the needle even in a state in which the light path portion is fixed.

Referring to FIG. 2 , the user fixes the position of the light path unit 300 by operating the fixing member 140 in a state in which the light path unit 300 is inserted to a position adjacent to the end of the needle 122 . In this case, the force by which the fixing member 140 presses the optical path part 300 is greater than the frictional force generated between the sealing part 135 and the optical path part 300 when the movable member 130 moves forward and backward. Accordingly, it is possible for the light path unit 300 to maintain a fixed position even while moving the movable member forward or backward to receive the material or inject the material.

3 is a diagram illustrating the structure of an ocular mass delivery device according to a third embodiment. In the embodiment shown in Figure 3, it is configured to further include an insertion pipe 150 that is fixedly installed inside the housing. The insertion conduit 150 forms a path into which the light path unit 300 is inserted, and is fixedly installed inside the housing 110 . In Figure 3, the insertion path discloses a structure that is fixedly installed inside the front end of the housing (even in this case, the material movement path between the receiving part and the needle is configured to be secured), in addition to this, it is fixedly installed at the outer rear end of the housing It is also possible to be composed of a structure in which

And, when the movable member 130 is inserted into the housing, the insertion tube 150 is disposed along the hollow 134 of the movable member 130 in a structure through which it penetrates. In addition, the sealing part 135 of the movable member 130 seals the outer surface of the insertion pipe 150 to prevent the material of the receiving part from flowing into the hollow of the movable member.

In this case, even when the movable member 130 moves forward and backward, the insertion pipe 150 maintains a fixed state. Therefore, the light path unit 300 is inserted through the insertion tube 150 to a position adjacent to the end of the needle, it is possible to maintain a fixed position while the subsequent procedure is in progress.

As described above, the injection device disclosed herein is configured to discharge light from the needle end using an external light source, and the structure of the injection device may be modified and implemented in various ways.

4 is a diagram illustrating a traveling path of light irradiated through a light path unit. As described above, in the mass transfer device 10 of the present specification, the user can visually confirm the position of the end of the needle without a separate lighting device by emitting light from the end of the needle. Furthermore, the mass transfer device of the present specification may be configured to confirm the positional information of the needle end by receiving light reflected from the tissue.

As shown in FIG. 4 , the light path unit 300 positioned at the end of the needle 122 irradiates light through the end. In addition, light reflected from an adjacent tissue (eg, fundus) may be received and transmitted to the detection unit 220 of the main body 200 . And, the detection unit 220 includes a detection element capable of detecting the light information, it is possible to detect the received light to confirm the position information of the needle end.

As an example, the light irradiated through the end of the light path unit 300 proceeds with phenomena such as spreading and scattering. Therefore, when the light reflected from the fundus is received through the optical path unit 300 , the closer the end (the end of the needle) of the light path unit 300 is to the fundus, the higher the intensity of the reflected light received, and the farther away from the fundus is. The lower the intensity of the reflected light received. Accordingly, the detection unit 220 uses the information of the reflected light received through the light path unit 300 to determine the position information of the needle end, that is, the relative distance information between the needle end and the fundus (or the inner wall of the eye).

Accordingly, the control unit may display the position information of the needle end detected by the detection unit 220 to the user through a separate display unit (not shown). Alternatively, the control unit continuously monitors the information detected by the detection unit 220, and when it is confirmed that the end of the needle is located at a preset distance from the fundus, using a sound or other visual method through a separate notification unit 230 It can also be configured to notify the user of this.

However, in the above, it is described as checking the position information of the end of the needle using the intensity of the reflected light received, but it is not limited to this, and it is configured to check the position information of the end of the needle using various parameters of the reflected light. make it clear that you can

5 is a diagram illustrating a state in which a therapeutic substance is delivered into the eyeball using the above-described injection device. As shown in FIG. 5 , the needle is inserted into the eyeball by the user through the sclera of the patient. At this time, the injection device for the eye is in a state in which the treatment material is accommodated in the receiving unit, and the light transmitted from the external light source is irradiated to the inside of the eyeball through the light path unit located at the end of the needle. The user may insert the needle into the eyeball while checking the position of the needle end during the procedure with the naked eye or using a separate microscope. Furthermore, the user can insert the needle end to a target position while checking the position information (distance from the eyeball wall, etc.) of the needle end obtained using the light reflected from the eyeball wall through the display unit or the notification unit. Then, when it is confirmed that the end of the needle has reached a target position, for example, the vitreous cavity, the user may stop further insertion and press the movable member to deliver the therapeutic material to the corresponding position.

As such, according to the present invention, it is possible to inject a substance while checking the position of the needle end located in the body using an external light source, and to precisely measure the distance from the tissue by using the light reflected from the tissue. It is possible to determine the location of material injection while measuring. Therefore, by delivering the therapeutic substance to the correct location, it is possible to improve the therapeutic effect and prevent tissue damage due to invasion.

However, in the above-described embodiment, the ocular mass delivery device has been mainly described, but the present invention is not limited thereto, and it can be applied to various structures that are invasively inserted into other body tissues other than the ocular injection device to deliver substances. make it clear that

In addition, although the above-described embodiment has been mainly described for the use of delivering a therapeutic material accommodated in the injection device, the present invention can also be applied to the case of using an injection device for collecting body material. make it clear

As mentioned above, although one embodiment of the present invention has been described in detail, the present invention is not limited to the above embodiment. It is revealed that those of ordinary skill in the art to which the present invention pertains can practice the present invention with various modifications or changes without departing from the scope of the technical features of the present invention as defined in the appended claims. put

Claims (5)

The needle is installed at one end, the body having a receiving portion in which the delivery material is accommodated;
a movable member installed to move forward and backward along the inside of the body so as to deliver the delivery material to the treatment site through the needle; and
and a light path part disposed along the length direction of the body or the movable member and forming a path through which light transmitted from an external light source is irradiated to the needle end. According to claim 1,
The light path portion is installed to be inserted into the inside of the movable member, the eye material delivery device, characterized in that provided to be movable according to the forward and backward movement of the movable member. According to claim 1,
The light path part is provided on a separate path provided inside the body or the movable member, and the end of the optical path part is fixed in a position adjacent to the end of the needle while the movable member moves forward and backward. A material delivery device for the eye, characterized in that. According to claim 1,
The ocular material delivery device, characterized in that it further comprises a detection unit for obtaining the position information of the needle end by detecting that the light irradiated to the needle end is reflected from the inside of the eyeball and is received by the light path unit. 5. The method of claim 4,
When it is detected that the needle end is located at a preset distance from the fundus by the detection unit, a notification unit for notifying the user thereof is further included.

Images