A skin extractor for subcutaneous injection of heparin sodium injection

Abstract

The utility model relates to a skin extractor for heparin sodium injection hypodermic injection, and particularly relates to the technical field of medical apparatus and instruments. It comprises a sucking disc assembly, a negative pressure generating device and a puncture guide module, wherein: the sucking disc assembly is a double-layer adsorption structure, comprising concentrically arranged outer ring sucking disc and inner ring sucking disc, the outer edge of the outer ring sucking disc is provided with a wave-shaped buffer sealing ring, and the bottom surface of the inner ring sucking disc is provided with a spiral groove array; the pressure balance channel for connecting the inner and outer ring sucking discs is provided with a nanometer silicon dioxide hydrophobic coating on the inner wall; the negative pressure generating device comprises a miniature electric vacuum pump and a detachable lithium battery pack; the puncture guide mechanism comprises a ratchet type angle regulator and a guide channel. The double-layer structure sucking disc assembly design, the wave-shaped buffer sealing ring on the outer edge of the outer ring sucking disc can closely adhere to the skin of the patient, effectively disperses the adsorption pressure, increases the contact area with the skin, enhances the adsorption force, and ensures the stability and reliability of the skin extraction process, thereby providing a good foundation for hypodermic injection.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a skin extractor for subcutaneous injection of heparin sodium injection solution. Background Technology

[0002] In clinical practice, heparin sodium is a commonly used anticoagulant drug, and subcutaneous injection is an important route of administration. Proper subcutaneous injection requires pinching the patient's skin to create folds in the subcutaneous tissue. This effectively injects the drug into the subcutaneous fat layer, avoiding injection into the muscle layer, thereby reducing adverse reactions such as pain, bleeding, and induration, and ensuring effective drug absorption and therapeutic efficacy.

[0003] However, in practice, this routine procedure presents significant challenges for certain patient groups. For instance, patients with very little abdominal fat lack sufficient fat support in their skin, making it difficult to create ideal skin folds simply by pinching the skin, unlike healthy patients. Clinical studies have shown that these patients are approximately 30% more likely to have inaccurate injection sites when receiving subcutaneous heparin sodium injections due to the difficulty in pinching the skin, and the incidence of local adverse reactions is also correspondingly increased.

[0004] Currently, there is a lack of effective solutions to this problem in clinical practice. Traditional manual skin-creation methods are ineffective for these patients, and existing medical devices lack specific assistive devices designed for this condition. This not only complicates the operation for medical staff, increasing the difficulty and time required, but also causes more pain and potential health risks to patients, affecting the therapeutic effect of heparin sodium and the patient's recovery process. Therefore, developing a device that can effectively assist in forming skin folds is an urgent practical need to improve the accuracy and safety of subcutaneous heparin sodium injection and enhance the patient's medical experience. Utility Model Content

[0005] The purpose of this invention is to provide a skin extractor for subcutaneous injection of heparin sodium injection solution.

[0006] To achieve the above objectives, this utility model provides the following technical solution:

[0007] A skin extraction device for subcutaneous injection of heparin sodium injection solution includes: a suction cup assembly, a negative pressure generating device, and a puncture guide module, wherein:

[0008] The suction cup assembly has a double-layer adsorption structure with a spacing of 2.5-3.5mm between the two layers and a total height of 8-10mm. It is made of medical-grade silicone with a Shore hardness of 40-50. The suction cup assembly includes a concentric outer ring suction cup and an inner ring suction cup. The outer ring suction cup has a wavy buffer sealing ring on its outer edge, and the bottom surface of the inner ring suction cup has a spiral groove array. A pressure balance channel connecting the outer ring suction cup and the inner ring suction cup has a nano-silica hydrophobic coating on its inner wall. The outer diameter of the outer ring suction cup is 40-50mm, and the outer diameter of the inner ring suction cup is 18-22mm.

[0009] The negative pressure generating device includes a miniature electric vacuum pump and a detachable lithium battery pack. The miniature electric vacuum pump is connected to the pressure balance channel through a flexible conduit, and the miniature electric vacuum pump and the detachable lithium battery pack are integrated in an independent control box and electrically connected to the suction cup assembly through a quick-connect plug.

[0010] The puncture guide module is fixed directly above the center of the suction cup assembly by a rotatable bracket. The axis of the guide channel coincides with the central axis of the inner ring suction cup. The puncture guide module includes a ratchet-type angle adjuster and a guide channel.

[0011] Furthermore, the corrugated buffer sealing ring has a peak height of 0.5-0.8 mm, a trough depth of 0.3-0.5 mm, a wavelength of 5-8 mm, and a Shore hardness of 25-35. It is co-molded with the outer ring suction cup.

[0012] Furthermore, the spiral groove array has a groove diameter of 0.5-1mm, a spiral helix angle of 15°-25°, a radial spacing of 3-5mm between adjacent spiral lines, and a groove depth of 0.2-0.3mm.

[0013] Furthermore, the pressure balance channel is an annular channel with a semi-circular cross-section, a channel diameter of 2.5-3.5mm, a distance of 1.2-1.8mm between the channel and the bottom surface of the suction cup assembly, and a channel inner wall curvature radius R = 0.8-1.2mm.

[0014] Furthermore, the nano-silica hydrophobic coating is composed of silica particles with a particle size of 50-80nm, a thickness of 10-15μm, a contact angle of >150°, and a surface roughness Ra of <0.1μm.

[0015] Furthermore, the guide channel incorporates a coaxially arranged 850nm laser emitter and a 1280×960 pixel CMOS sensor. The laser emitter and CMOS sensor are arranged side by side along the axial direction of the guide channel, with the center of the laser spot coinciding with the center of the CMOS sensor's field of view. The distance between the optical components and the bottom surface of the suction cup assembly is adjustable from 10 to 15 mm.

[0016] Furthermore, the detachable lithium battery pack is equipped with a reverse connection anti-reverse connection buckle interface, has a battery capacity of 2000mAh, and dimensions of 60×40×8mm, supporting 300 complete charge-discharge cycles. The reverse connection anti-reverse connection buckle interface is located in the groove at the bottom of the control box and is equipped with a bidirectional conduction detection circuit. The flexible conduit has an inner diameter of Φ3.0±0.2mm, a wall thickness of 0.5mm, a length of 1.2-1.5m, and remains unobstructed when the burst pressure is ≥200kPa and the bending radius is ≤30mm.

[0017] Furthermore, the ratchet-type angle adjuster has 12 positioning teeth, each corresponding to a 3° adjustment amount, a maximum load torque of 0.5 N·m, a return clearance of <0.5°, and its rotation axis is orthogonal to the guide channel axis. The guide channel has an inner diameter of 2.6±0.1 mm, a length of 25-30 mm, an inner wall roughness Ra≤0.4 μm, a chamfer of 0.3×45° at the front end, and a clearance fit tolerance of H7 / g6 with the puncture needle.

[0018] Furthermore, the power output range of the laser emitter is 5-15mW, the beam divergence angle is <2°, and the spot diameter is ≤0.5mm; the frame rate of the CMOS sensor is not less than 30fps, the field of view is 60°±2°, the working distance is 10-50mm, the focusing accuracy is ±0.1mm, and it is equipped with a Φ6mm aspherical lens.

[0019] Furthermore, the rotatable bracket is made of 6061-T6 aluminum alloy, with a bracket arm length of 80-100mm, a diameter of Φ6mm, a rotation angle range of 0-180°, an axial extension and retraction adjustment stroke of 20mm, and a locking nut torque of 1.2-1.8N·m.

[0020] The beneficial effects of this utility model are as follows:

[0021] 1. Enhanced Patient Comfort and Adsorption Stability: The dual-layer suction cup assembly features an ingenious design. The outer ring suction cup's wavy buffer sealing ring, with its carefully designed peak height, trough depth, wavelength, and Shore hardness, is co-molded with the outer ring suction cup, ensuring a close fit to the patient's skin and effectively dispersing adsorption pressure, significantly improving patient comfort. The inner ring suction cup's bottom surface features a spiral groove array. Through specific groove diameters, spiral angles, radial spacing between adjacent spiral lines, and groove depth, the contact area with the skin is increased, enhancing adsorption force and ensuring a stable and reliable skin extraction process, providing a good foundation for subcutaneous injection.

[0022] 2. Optimized Internal Structure and Protective Performance: The pressure balance channel connecting the inner and outer ring suction cups features a nano-silica hydrophobic coating on its inner wall composed of particles of a specific size, possessing ideal thickness, contact angle, and surface roughness. This design not only precisely balances the pressure between the inner and outer ring suction cups, maintaining a stable adsorption state, but also effectively resists liquid intrusion, prevents damage to internal components, extends the equipment's service life, and ensures the equipment's reliability in various operating environments.

[0023] 3. Improved Precision of Puncture Procedures: The puncture guidance mechanism is equipped with a ratchet-type angle adjuster, with 12 positioning teeth and an adjustment range of 3° per tooth. The maximum torque capacity is 0.5 N·m, and the backlash is <0.5°, allowing medical personnel to precisely adjust the puncture angle to meet the needs of different patients and injection sites. Simultaneously, the guidance channel incorporates a coaxially mounted 850nm laser emitter and a high-resolution CMOS sensor. The laser emitter has a power output range of 5-15mW and a beam divergence angle of <2°, while the CMOS sensor has a frame rate of at least 30fps. These two components work together to provide precise positioning guidance for punctures, significantly improving the accuracy of subcutaneous injections and reducing various problems caused by inaccurate punctures.

[0024] 4. Enhanced ease of use and durability: The removable lithium battery pack in the negative pressure generator features a reverse connection protection clip to effectively prevent damage to the device caused by incorrect battery installation. Its 2000mAh battery capacity and 60×40×8mm dimensions make the device easy to carry and use, and it supports 300 complete charge-discharge cycles, ensuring that the device does not require frequent battery replacements during extended use. This greatly facilitates clinical use and improves the device's efficiency and durability. Attached Figure Description

[0025] Figure 1 This is a top view of the overall structure of Example 1.

[0026] Figure 2 This is a schematic diagram of a ratchet-type angle adjuster.

[0027] Figure 3 This is a cross-sectional view of the optical components of the guidance channel.

[0028] In the diagram: 110, outer ring suction cup; 120, inner ring suction cup; 130, wave-shaped buffer sealing ring; 140, spiral groove array; 150, pressure balance channel; 160, nano-silica hydrophobic coating; 210, miniature electric vacuum pump; 220, removable lithium battery pack; 230, anti-reverse connection snap-fit ​​interface; 240, flexible conduit; 250, control box; 260, quick plug; 310, ratchet angle adjuster; 320, guide channel; 330, laser emitter; 340, CMOS sensor; 350, rotatable bracket. Detailed Implementation

[0029] The device of this utility model will be described in detail below. The examples given are only for explaining this utility model and are not intended to limit the scope of this utility model.

[0030] Example 1

[0031] A skin extraction device for subcutaneous injection of heparin sodium injection includes a suction cup assembly, a negative pressure generating device, and a puncture guide module. Figure 1 ).

[0032] 1. Suction cup assembly:

[0033] The outer ring suction cup 110 has an outer diameter of 45mm, the inner ring suction cup 120 has an outer diameter of 20mm, the distance between the two suction cups is 3mm, the total height is 9mm, and the material is medical-grade silicone with a Shore hardness of 45. The outer ring suction cup has a wavy buffer sealing ring 130 on its edge, with a cross-sectional peak height of 0.6mm, a trough depth of 0.4mm, a wavelength of 6mm, and a Shore hardness of 30. It is co-molded with the outer ring suction cup 110. The bottom surface of the inner ring suction cup is machined with a spiral groove array 140, with a groove diameter of 0.8mm, a spiral helix angle of 20°, a radial spacing of 4mm, and a groove depth of 0.25mm. The pressure balance channel 150 is an annular semi-circular cross-section channel with a diameter of 3mm, located 1.5mm from the bottom surface of the suction cup, and an inner wall curvature radius R = 1.0mm. It is coated with a nano-silica hydrophobic coating 160 with a coating thickness of 12μm, a contact angle of 155°, and Ra = 0.08μm.

[0034] 2. Negative pressure generating device:

[0035] The integrated micro electric vacuum pump 210 and the detachable lithium battery pack 220 are housed in the control box 250. The battery capacity is 2000mAh and it has a reverse connection buckle interface 230. The flexible conduit 240 has an inner diameter of Φ3.0mm, a length of 1.3m, and a burst pressure of 220kPa. It is connected to the suction cup assembly via a quick-connect plug 260.

[0036] 3. Puncture guidance module:

[0037] Ratchet angle adjuster 310 ( Figure 2 It contains 12 teeth, each corresponding to a 3° angle. The guide channel 320 has an inner diameter of 2.6 mm, a length of 28 mm, an inner wall Ra = 0.3 μm, and a front chamfer of 0.3 × 45°. The guide channel integrates an 850nm laser emitter 330 with a power of 10 mW and a divergence angle of 1.8°, and a 1280 × 960 pixel CMOS sensor 340 with a frame rate of 30 fps, a field of view of 60°, and a focusing accuracy of ±0.1 mm. Figure 3 The 350mm rotatable bracket, made of 6061-T6 aluminum alloy, has an arm length of 90mm, a rotation range of 0-180°, and a telescopic stroke of 20mm. It is fixed directly above the suction cup assembly.

[0038] When using:

[0039] I. Preparations before operation

[0040] 1. Component Inspection

[0041] Confirm that the double-layer structure of the suction cup assembly is undamaged, the wavy buffer sealing ring 130 is intact, and the spiral groove array 140 is clean and unblocked; check whether the hydrophobic coating 160 of the pressure balance channel 150 is intact to avoid condensate retention; test the power of the removable lithium battery pack 220, the indicator light on the control box 250, and ensure that the negative pressure generation of the micro vacuum pump 210 is normal, with a target negative pressure value of -30 to -40 kPa.

[0042] 2. Disinfection treatment

[0043] The parts of the suction cup assembly and the puncture guide module that come into contact with the skin must be wiped with 75% ethanol; the inner wall of the guide channel 320 should be cleaned with sterile cotton swabs to ensure that there are no residues on the tolerance mating surface H7 / g6.

[0044] II. Operating Procedures

[0045] 1. Skin adsorption positioning: Press the suction cup assembly onto the injection site, such as the abdomen, activate the negative pressure device, and observe that the skin is evenly lifted to the center of the inner ring suction cup 120; the spiral groove array 140 enhances the skin's stretching stability, with a retraction rate ≤5% and a negative pressure maintenance time ≥15 minutes.

[0046] 2. Puncture angle calibration: Adjust the extension stroke of the rotatable bracket 350 by 20mm so that the front end of the guide channel 320 is 12mm away from the skin surface; turn on the 850nm laser emitter 330 and CMOS sensor 340, and project the laser spot diameter ≤0.5mm onto the center of the skin fold, and monitor the puncture path in real time through a field of view of 60°.

[0047] 3. Injection execution: Rotate the ratchet-type angle adjuster 310, 3° per tooth, and fix the guide channel 320 at the preset angle; insert the heparin sodium injection needle along the guide channel 320, with tolerance H7 / g6, and advance at a uniform speed after the needle tip contacts the laser spot. The CMOS sensor 340 provides real-time feedback on the puncture depth with an accuracy of ±0.1mm.

[0048] III. Post-use maintenance

[0049] 1. Negative pressure release and disassembly: Press the pressure relief valve on the control box 250 to slowly release the negative pressure and avoid instantaneous skin rebound; when disassembling the lithium battery pack 220, disconnect the power through the anti-reverse connection buckle interface 230 to avoid short circuit.

[0050] 2. Cleaning and storage: The nano-silica hydrophobic coating 160 should not be scratched by hard objects. Wipe it with a soft cloth dampened with neutral detergent. The rotatable bracket 350 locks the nut back to 1.5 N·m torque to avoid fatigue deformation of the aluminum alloy material.

[0051] IV. Precautions

[0052] 1. Contraindications: Do not use in areas with broken skin, scar tissue, or subcutaneous fat thickness <10mm, to avoid uneven adhesion leading to subcutaneous bleeding; the lithium battery pack 220 must be disconnected from the control box 250 when charging to prevent overcharging and thermal runaway.

[0053] 2. Troubleshooting:

[0054] Insufficient negative pressure: Check if the bending radius of the flexible catheter 240 is greater than 30mm, or if the spiral groove 140 is blocked;

[0055] Laser offset: Calibrate the CMOS sensor 340 and the aspherical lens Φ6mm to ensure that the center of the spot coincides with the center of the field of view.

[0056] By using a double-layer suction cup with synergistic negative pressure adsorption, the uniformity of adsorption force distribution is improved by 40%, the wave sealing ring compensates for the skin curvature and the sealing qualification rate is 98%, and the spiral groove enhances the skin's tensile stability, i.e., the retraction rate is ≤5%. Combined with laser-CMOS real-time positioning, the angle error is <0.5°, achieving a heparin sodium injection depth accuracy of ±0.3mm, which significantly reduces the incidence of subcutaneous hematoma. Clinical trial data: 3.2% in the example group vs. 14.7% in the control group. The comparison results are shown in Table 1.

[0057] Table 1

[0058] Skin Adsorption Double-layer negative pressure uniform lifting, error < ±0.3mm Single-layer suction cups are prone to displacement, with an error greater than ±1.2mm. Puncture guidance Laser + CMOS real-time positioning, angular accuracy 0.5° Manual visual inspection angle deviation ≥3° negative pressure maintenance Hydrophobic coating + wave seal, maintains for ≥15 minutes For ordinary sealing rings, leakage should persist for ≤5 minutes.

[0059] Comparative Example 1 (Single-layer suction cup structure)

[0060] The suction cup assembly has only a single-layer outer ring suction cup (outer diameter 45mm, Shore hardness 45), without an inner ring suction cup and pressure balance channel; the rest of the structure is the same as in Example 1, but the skin deformation is uneven during negative pressure suction, and the injection depth deviation reaches ±1.2mm.

[0061] Comparative Example 2 (Non-wavy sealing ring)

[0062] The outer ring suction cup sealing ring is a flat rubber ring (Shore hardness 30, height 0.6mm) without a wavy structure; the rest is the same as in Example 1. The test showed that the sealing performance decreased by 30% and the negative pressure maintenance time was shortened to 5 minutes.

[0063] Comparative Example 3 (channel without hydrophobic coating)

[0064] The inner wall of the pressure balance channel was not coated with a nano-silica hydrophobic coating; otherwise, it was the same as in Example 1. Under the same operating conditions, the amount of condensate accumulation in the channel increased by 4 times, resulting in a 2-second delay in the negative pressure response time.

[0065] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.

Claims

1. A skin extractor for subcutaneous injection of heparin sodium injection solution, characterized in that: include: The suction cup assembly, negative pressure generating device, and puncture guide module include: The suction cup assembly has a double-layer adsorption structure with a spacing of 2.5-3.5mm between the two layers and a total height of 8-10mm. It is made of medical-grade silicone with a Shore hardness of 40-50. The suction cup assembly includes a concentric outer ring suction cup (110) and an inner ring suction cup (120). The outer ring suction cup (110) has a wave-shaped buffer sealing ring (130) on its outer edge, and the bottom surface of the inner ring suction cup has a spiral groove array (140). A pressure balance channel (150) connects the outer ring suction cup (110) and the inner ring suction cup (120), and the inner wall is provided with a nano-silica hydrophobic coating (160). The outer diameter of the outer ring suction cup (110) is 40-50mm, and the outer diameter of the inner ring suction cup (120) is 18-22mm. The negative pressure generating device includes a miniature electric vacuum pump (210) and a detachable lithium battery pack (220). The miniature electric vacuum pump (210) is connected to the pressure balance channel (150) through a flexible conduit (240), and the miniature electric vacuum pump (210) and the detachable lithium battery pack (220) are integrated in an independent control box (250) and electrically connected to the suction cup assembly through a quick connector (260). The puncture guide module is fixed above the center of the suction cup assembly by a rotatable bracket (350). The axis of the guide channel (320) coincides with the central axis of the inner ring suction cup (120). The puncture guide module includes a ratchet-type angle adjuster (310) and a guide channel (320).

2. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 1, characterized in that: The corrugated buffer sealing ring (130) has a peak height of 0.5-0.8 mm, a trough depth of 0.3-0.5 mm, a wavelength of 5-8 mm, and a Shore hardness of 25-35. It is co-molded with the outer ring suction cup (110).

3. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 1, characterized in that: The spiral groove array (140) has a groove diameter of 0.5-1mm, a spiral helix angle of 15°-25°, a radial spacing of 3-5mm between adjacent spiral lines, and a groove depth of 0.2-0.3mm.

4. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 1, characterized in that: The pressure balance channel (150) is an annular channel with a semi-circular cross-section, a channel diameter of 2.5-3.5mm, a distance of 1.2-1.8mm between it and the bottom surface of the suction cup assembly, and a channel inner wall curvature radius R = 0.8-1.2mm.

5. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 1, characterized in that: The nano-silica hydrophobic coating (160) is composed of silica particles with a particle size of 50-80nm, a thickness of 10-15μm, a contact angle of >150°, and a surface roughness Ra <0.1μm.

6. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 1, characterized in that: The guide channel (320) houses a coaxially arranged 850nm laser emitter (330) and a 1280×960 pixel CMOS sensor (340). The laser emitter (330) and the CMOS sensor (340) are arranged side by side along the axial direction of the guide channel (320), with the center of the laser spot coinciding with the center of the CMOS sensor's field of view. The distance between the optical components and the bottom surface of the suction cup assembly is adjustable from 10 to 15 mm.

7. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 1, characterized in that: The detachable lithium battery pack (220) is equipped with a reverse connection locking interface (230), has a battery capacity of 2000mAh, and has external dimensions of 60×40×8mm. It supports 300 complete charge and discharge cycles. The reverse connection locking interface (230) is located in the bottom groove of the control box (250) and is equipped with a bidirectional conduction detection circuit. The flexible conduit (240) has an inner diameter of Φ3.0±0.2mm, a wall thickness of 0.5mm, a length of 1.2-1.5m, a burst pressure ≥200kPa, and remains unobstructed when the bending radius is ≤30mm.

8. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 1, characterized in that: The ratchet-type angle adjuster (310) has 12 positioning teeth, each tooth corresponding to a 3° adjustment amount, a maximum bearing torque of 0.5 N·m, a return clearance of <0.5°, and its rotation axis is orthogonal to the axis of the guide channel (320). The guide channel (320) has an inner diameter of 2.6 ± 0.1 mm, a length of 25-30 mm, an inner wall roughness Ra ≤ 0.4 μm, a chamfer of 0.3 × 45° at the front end, and a clearance fit tolerance of H7 / g6 with the puncture needle.

9. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 6, characterized in that: The laser emitter (330) has a power output range of 5-15mW, a beam divergence angle of <2°, and a spot diameter of ≤0.5mm; the CMOS sensor (340) has a frame rate of not less than 30fps, a field of view of 60°±2°, a working distance of 10-50mm, a focusing accuracy of ±0.1mm, and is equipped with a Φ6mm aspherical lens.

10. The skin extractor for subcutaneous injection of heparin sodium injection according to claim 1, characterized in that: The rotatable bracket (350) is made of 6061-T6 aluminum alloy, with a bracket arm length of 80-100mm, a diameter of Φ6mm, a rotation angle range of 0-180°, an axial extension adjustment stroke of 20mm, and a locking nut torque of 1.2-1.8N·m.

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