Superfine telescopic microneedle device
By designing a super-substantial needle device with curve and flexible catheter, the problems of subretinal injection operation are solved and the surgical errors are large, achieving more stable injection of medicine and lower risk of retinal damage.
Patent Information
- Application Number
- CN202520277522.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-02-21
- Publication Date
- 2025-03-28
- Estimated Expiration
- 2035-02-21
AI Technical Summary
The operation is difficult during the subretinal injection and the surgical error is large, which leads to unstable drug injection and may trigger immune responses and damage to the retinal tissue.
An ultrafine retractable microneedle device is designed, including ultrafine needles with curved and flexible catheters, combined with clamping push buttons and hose connection components to achieve retractable and multi-angle operation of the microneedle.
The arc design improves the operating angle, which facilitates multi-point subretinal injection; the telescopic design improves the control of needle angle and force, reduces surgical errors, ensures the stability of injection of the medicine liquid, and reduces the risk of damage to the retina.
Smart Images
Figure CN222676665U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of puncture injection, in particular to an ultra-precision retractable micro-needle device. Background Art
[0002] The subretinal space is a potential cavity located between the retinal pigment epithelium and the photoreceptor cell layer. Subretinal injection is a method of delivering therapeutic drugs to the subretinal space. Compared with intravitreal injection, subretinal injection of drugs has a more direct and effective effect on retinal photoreceptor cells and retinal pigment epithelial cells, and the subretinal space is a safer area. It is anatomically closed and has immune privileges, which can minimize the risk of immune rejection and inflammation. In recent years, with the advancement of medical technology and the updating and development of surgical instruments, the clinical application scope of subretinal injection has gradually broadened. It has become one of the important drug delivery methods for gene therapy and cell therapy of various fundus diseases, playing an increasingly significant role.
[0003] The subretinal injection process is extremely delicate and requires strict operation of the surgeon, so there is an increasing demand for designing a device that enhances the convenience of operation and reduces the difficulty of operation. Utility Model Content
[0004] In order to solve the above technical problems, the utility model provides an ultra-precision retractable micro-needle device.
[0005] The utility model is realized through the following technical solutions.
[0006] An ultra-precision retractable microneedle device comprises a syringe, the head end of which is connected to a fixed needle head, an ultra-precision microneedle connecting component is slidably arranged in the syringe, and the ultra-precision microneedle connecting component is connected to a clamping push button arranged on the syringe; the head end of the ultra-precision microneedle connecting component is connected to an ultra-precision microneedle, and the ultra-precision microneedle penetrates into the fixed needle head; the ultra-precision microneedle comprises a needle tube, a flexible catheter and a microneedle head which are connected and communicated in sequence, and the flexible catheter is bent into a certain arc; the tail end of the ultra-precision microneedle connecting component is connected to a rubber hose.
[0007] Furthermore, a sliding groove is provided on the upper surface of the syringe along the extension direction of the syringe, and the clamping push button is placed in the sliding groove and passes through the bottom of the sliding groove to be connected with the ultra-fine micro needle connecting assembly.
[0008] Furthermore, the clamping push button includes a substrate, the upper surface of the substrate is connected to the push button, and the lower surface of the substrate is provided with a connecting block, which is connected to the ultra-fine micro needle connecting assembly.
[0009] Furthermore, the ultra-fine microneedle connection assembly includes a hose connection part and a clamping push button connection part that are connected to each other, the tail end of the hose connection part is connected to the hose, and the head end of the clamping push button connection part is connected to the ultra-fine microneedle.
[0010] Furthermore, the clamping push button connecting portion is also connected to the clamping push button.
[0011] Furthermore, the tail end of the hose is placed outside the syringe and is connected to a connector.
[0012] Furthermore, the tail end of the syringe is movably connected to the tail buckle, and a through hole for the rubber hose to pass through is formed in the center of the tail buckle.
[0013] This application has the following beneficial effects.
[0014] According to the structural characteristics of the eyeball, the utility model designs the head of the device to be a structure with an arc and retractable structure. The advantage of the arc is that it brings a larger operating angle. When the operator needs to inject subretinal injections at multiple points, the retina that can be touched is wider and the operation is more convenient. The advantage of telescopic is that the operator can better control the angle and strength of the needle, improve the convenience of the operation, and also avoid damaging the flexible needle when inserting and removing the protective cover. In addition, since the acceptable error of the subretinal injection operation is extremely small, it is necessary to avoid microneedle puncture too deep or too shallow. Too deep needle puncture can cause bleeding and permanent retinal pigment epithelial cell damage, and too shallow puncture can cause retinal tearing during blister formation. Therefore, the application has a curved and retractable head structure, which can reduce surgical errors and can timely adjust the degree and direction of the microneedle entering the subretinal cavity according to the surgical situation, ensuring that good stability can be maintained when injecting the drug solution, avoiding the injection hole from being enlarged, and the drug or virus vector reflux into the vitreous cavity to induce an immune response. The damage to the retinal tissue is also small, and the injection is safer and more reliable. After the injection, the retinal puncture hole can be self-closed and healed, greatly improving the success rate of the operation. The utility model has ingenious structural design, good clinical use effect and strong applicability. BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Figure 1 It is a structural schematic diagram of the utility model;
[0016] Figure 2 It is a cross-sectional view of the utility model;
[0017] Figure 3 This is an enlarged view of the interior of the syringe of the utility model;
[0018] Figure 4 It is a partially enlarged view of the ultra-fine micro needle of the utility model.
[0019] Among them, 1. fixed needle; 2. syringe; 21. sliding groove; 3. ultra-precision microneedle connection assembly; 31. hose connection part; 32. clamping push button connection part; 4. hose; 5. clamping push button; 51. push button; 52. base plate; 53. connecting block; 6. connector; 7. tail buckle; 8. ultra-precision microneedle; 81. needle tube; 82. flexible catheter; 83. microneedle. DETAILED DESCRIPTION
[0020] The utility model is further described below in conjunction with the accompanying drawings and embodiments.
[0021] like Figure 1-4 As shown, an ultra-precision retractable microneedle device includes a fixed needle head 1, a syringe 2, an ultra-precision microneedle connecting component 3, a hose 4, a clamping push button 5, a connector 6, a tail buckle 7 and an ultra-precision microneedle 8.
[0022] The head end of the syringe 2 is provided with a fixed needle 1. Specifically, the fixed needle 1 includes a base and a needle body. The outer wall of the base is fixedly connected to the inner wall of the head end of the syringe 2. The needle body is slender and has a beveled tip. The needle body is used to pierce the skin around the eyes.
[0023] A cavity is formed in the syringe 2, and an ultrafine micro needle connection component 3 is slidably arranged in the cavity. The ultrafine micro needle connection component 3 is used to connect the hose 4 and the ultrafine micro needle 8 to transport the liquid medicine. Specifically, the ultrafine micro needle connection component 3 is divided into two interconnected parts, namely, a hose connection part 31 and a clamping push button connection part 32. The outer diameter of the clamping push button connection part 32 is larger than the outer diameter of the hose connection part 31, and the inner diameters of the clamping push button connection part 32 and the hose connection part 31 are equal.
[0024] The tail end of the hose connector 31 is connected with a hose 4, which is a flexible tube that can be bent at any angle. Preferably, a fastener can be provided at the connection between the hose connector 31 and the hose 4 to ensure the stability of the connection between the two, and the fastener can be a structure such as a fastening hoop or a clamp. The tail end of the hose 4 passes through the syringe 2 and is connected to the connector 6, which is used to connect to the back-end equipment to achieve the introduction of the liquid medicine. Specifically, the head end of the connector 6 is inserted into the tail end of the hose 4, and a barb is formed on the outer wall of the head end of the connector 6 to prevent the connector 6 and the hose 4 from being disconnected.
[0025] The head end of the clamp push button connection part 32 is connected with an ultra-fine micro needle 8, and the ultra-fine micro needle 8 is inserted into the fixed needle head 1. Specifically, the ultra-fine micro needle 8 includes a connected needle tube 81, a flexible catheter 82 and a micro needle head 83. The needle tube 81 can be selected from a variety of models such as 23G, 25G, 27G, etc. The rear end of the needle tube 81 is inserted into the head end of the clamp push button connection part 32, and the front end of the needle tube 81 is connected to the flexible catheter 82 with a 35° arc. The front end of the flexible catheter 82 is connected to the micro needle head 83. The diameter of the micro needle head 83 can be selected from a variety of specifications such as 0.10㎜, 0.06㎜, etc., and the length is 1.5mm-2mm. The neck of the ultra-fine micro needle 8 of the present application has a curvature, which can bring a larger operating angle to the operator and improve the convenience of surgery.
[0026] In the present application, a sliding groove 21 is formed downwardly at the upper part of the syringe 2, and a clamping push button 5 is slidably provided in the sliding groove 21, and the clamping push button 5 is connected to the ultra-fine micro needle connection component 3. Specifically, a through hole is formed in the middle of the bottom of the sliding groove 21, and the through hole connects the sliding groove 21 with the cavity in the syringe 2. The clamping push button 5 includes a substrate 52 placed in the sliding groove 21, and the substrate 52 can slide back and forth along the sliding groove 21. The push button 51 is provided on the upper surface of the substrate 52, and a connecting block 53 is connected to the lower surface of the substrate 52. The connecting block 53 passes through the through hole at the bottom of the sliding groove 21 and is placed in the cavity of the syringe 2, and the connecting block 53 is connected to the clamping push button connecting portion 32. When the thumb pushes the push button 51 forward, the connection block 53 drives the ultrafine micro needle connection assembly 3 to move its head end in the syringe 2. At this time, the ultrafine micro needle 8 extends from the fixed needle 1. Since the neck of the ultrafine micro needle 8 is a flexible catheter 82 with a certain curvature, the micro needle 83 is at a certain angle to the fixed needle 1. After the treatment is completed, the thumb pulls the push button 51 backward, and the connection block 53 drives the ultrafine micro needle connection assembly 3 to move its tail end in the syringe 2. At this time, the ultrafine micro needle 8 is hidden in the fixed needle 1, thereby avoiding damage to the micro needle tip or sharp injury when inserting and removing the protective cover of conventional products.
[0027] The present application has a tail buckle 7 movably connected to the tail end of the syringe 2, which is engaged with the syringe 2. A through hole is formed in the center of the tail buckle 7, through which the rubber tube 4 passes. The tail buckle 7 is used to close the syringe 2 and also to hold the rubber tube 4 to reduce the risk of fluid retention. A triangular indicator arrow can also be designed on the tail buckle 7 of the present application to indicate the direction of pushing the needle.
[0028] The method of using the utility model is as follows:
[0029] (1) Connect the tail of the microfluidic control (VFC) syringe to the silicone oil infusion tube, and connect the other end of the silicone oil infusion tube to the vitrectomy machine; (2) Install a filter needle on the head of the VFC syringe, adjust the suction to 650 mmHg (1 mmHg=0.133 kPa) in the silicone oil removal mode of the vitrectomy machine, control the foot pedal, extract an appropriate amount of therapeutic drug, and mark it on the syringe; (3) Replace the filter needle on the head of the VFC syringe with the ultra-precision retractable microneedle device of this application, adjust the push pressure to 20 mmHg in the silicone oil injection mode of the vitrectomy machine, control the foot pedal, push the therapeutic drug in the VFC syringe to an appropriate amount, and expel any visible small bubbles (any bubbles in the injection microneedle and syringe must be removed and the permeability of the microneedle must be confirmed); finally, a VFC injection system with a silicone oil infusion tube connected to the tail and the ultra-precision retractable microneedle device of this application installed on the head, and the bubbles are arranged and the therapeutic drug is loaded for use. (4) During injection, adjust the vitrectomy machine to the silicone oil injection mode and set the maximum injection pressure to 20-25 mmHg; (5) Turn on the surgical microscope integrated with OCT (optical coherence tomography), scan the posterior pole retina in standard mode, and adjust it to be clear; (6) Insert the VFC syringe loaded with the drug into the vitreous cavity through the cannula, position the surgical microscope integrated with OCT scanning near the injection point, and start scanning the retina; (7) Establish a conventional 23G / 25G / 27G three-channel vitrectomy through the pars plana, insert the fixed needle 1 into the vitreous cavity through the cannula, push the clamping button 5 forward, and move the ultra The microneedle head 83 of the fine microneedle 8 contacts the surface of the retina or blood vessel at the planned injection point, and the tip of the microneedle head 83 gently penetrates the retina or blood vessel. The surgical microscope integrated with OCT can observe that the syringe needle tip located on the retinal surface is low-reflective, and the retina is pressed by the needle tip, showing a small depression; (8) Control the foot pedal to push the drug solution into the connector 6, and the drug solution passes through the rubber tube 4 and the ultra-fine microneedle connecting component 3, and finally reaches the target injection point through the ultra-fine microneedle 8 until a small dome-shaped localized retinal bulge blister is observed. Depending on the coverage of the target treatment area, the required drug dose can be achieved by increasing the number of injection points if necessary. After the injection is completed, the clamping push button 5 is pushed back, and the ultra-fine microneedle 8 is flexible and hides in the fixed needle head 1, and the microneedle injection device can be pulled out from the sleeve along the original path.
[0030] The embodiments of this specific implementation method are all preferred embodiments of the utility model, and are not intended to limit the protection scope of the utility model. Therefore, all equivalent changes made based on the structure, shape, and principle of the utility model should be included in the protection scope of the utility model.
Claims
1. An ultra-precision retractable microneedle device, comprising a needle barrel (2), characterized in that: The head end of the syringe (2) is connected to a fixed needle head (1), and an ultrafine micro needle connection component (3) is slidably provided in the syringe (2), and the ultrafine micro needle connection component (3) is connected to a clamping push button (5) provided on the syringe (2); the head end of the ultrafine micro needle connection component (3) is connected to an ultrafine micro needle (8), and the ultrafine micro needle (8) penetrates into the fixed needle head (1); the ultrafine micro needle (8) comprises a needle tube (81), a flexible catheter (82) and a micro needle head (83) which are connected and communicated in sequence, and the flexible catheter (82) is bent into a certain arc; the tail end of the ultrafine micro needle connection component (3) is connected to a rubber hose (4).
2. The ultra-precision retractable microneedle device according to claim 1, characterized in that: The upper surface of the needle barrel (2) is provided with a sliding groove (21) along the extension direction of the needle barrel (2), and the clamping push button (5) is placed in the sliding groove (21) and penetrates the bottom of the sliding groove (21) to be connected to the ultra-fine micro needle connection component (3).
3. The ultra-precision retractable microneedle device according to claim 1, characterized in that: The clamping push button (5) comprises a base plate (52), the upper surface of the base plate (52) is connected to the push button (51), the lower surface of the base plate (52) is provided with a connecting block (53), and the connecting block (53) is connected to the ultra-fine micro needle connecting assembly (3).
4. The ultra-precision retractable microneedle device according to claim 1, characterized in that: The ultra-fine micro-needle connection assembly (3) comprises a rubber hose connection part (31) and a clamping push button connection part (32) which are connected to each other, the tail end of the rubber hose connection part (31) is connected to the rubber hose (4), and the head end of the clamping push button connection part (32) is connected to the ultra-fine micro-needle (8).
5. The ultra-precision retractable microneedle device according to claim 4, characterized in that: The clamping push button connecting portion (32) is also connected to the clamping push button (5).
6. The ultra-precision retractable microneedle device according to claim 1, characterized in that: The tail end of the rubber hose (4) is placed outside the syringe (2) and is connected to a connector (6).
7. The ultra-precision retractable microneedle device according to claim 1, characterized in that: The tail end of the syringe (2) is movably connected to a tail buckle (7), and a through hole is formed in the center of the tail buckle (7) for the rubber hose (4) to pass through.