Body surface positioning point physical alignment device with anatomical feature self-adaption function and positioning suite of body surface positioning point physical alignment device

Abstract

The invention discloses a body surface positioning point physical alignment device with an anatomical feature self-adaption function. The body surface positioning point physical alignment device comprises a flexible base layer, hardness differential mechanical contacts and a function coupling bin with a conical guide groove. A'click 'sound feedback is generated through a clamping bony marker, and + / -1.5 mm positioning precision is realized; radial incisions compensate for skin stretching errors. Empirical body surface positioning point positioning is converted into standardized mechanical operation, and the technical problems that an existing product is poor in repeatability (gt; 15mm) and lacks somatosensory guidance are solved.

Description

Technical Field

[0001] This invention belongs to the field of medical device and ergonomics technology, specifically relating to a passive mechanical device that uses anatomical bony landmarks to achieve high-precision physical alignment of body surface positioning points, which is particularly suitable for standardized positioning of personalized transdermal drug delivery systems. Background Technology

[0002] Existing surface positioning patch products rely on manual visual positioning, which has three major technical drawbacks: 1. Poor repeatability: The positioning deviation for the same operator is often >15mm, and the deviation between different operators can reach 20-30mm; 2. Lack of tactile guidance: Purely visual positioning cannot utilize tactile feedback to verify accuracy; 3. Uncompensated skin deformation: Anisotropic stretching of the skin during limb flexion and extension causes the positioning point to drift by 5-10mm.

[0003] Even when combined with highly efficient intelligent formulations, the therapeutic effect will be reduced by 30-50% if the physical positioning is inaccurate. Current technology has not yet resolved the contradiction between "high-precision positioning" and "low-cost passive operation". Summary of the Invention

[0004] The core of this invention lies in constructing a passive positioning system of 'bone landmark capture - mechanical forced alignment - standardized interface coupling', and all its technical features are geometrically or mechanically represented in the accompanying drawings.

[0005] This invention provides a physical alignment device for body surface positioning points with anatomical feature self-adaptation function. It achieves physical positioning by using human bony landmarks through mechanical contacts with different hardness, combined with radial incisions to compensate for skin deformation, and controls the positioning deviation within ±1.5mm. It transforms human experience into repeatable mechanical tolerance and auditory feedback.

[0006] The device of the present invention can be implemented independently as a universal positioning platform for transdermal drug delivery devices. Its geometric alignment window (110) can form a sealed microenvironment with the drug release unit of the associated technology (application number 2026100810177, "A Meridian-Affiliated Drug Acupoint Patch Device with Body Surface Positioning Marks and Personalized Loading Method"), and can also independently solve the problem of poor positioning repeatability of physiotherapy products.

[0007] Combined advantages: After the mechanical alignment system and intelligent rheological control system of this invention are connected through the ISO standard interface, the overall positioning deviation can be reduced to ±0.8mm, the formulation CV value is ≤12%, and the four-dimensional precise matching of "drug-dosage form-body surface positioning point-body constitution" can be achieved. Attached Figure Description

[0008] Figure 1Exploded view of the structure (showing the functional coupling chamber, geometric alignment window, base layer, and dual-contact assembly relationship). Figure 2 : Top view of the base layer (showing the radial stress relief cutout distribution, window numbering, and contact point location) Figure 3 Human application real-world illustration (taking Zusanli as an example, showing the touch point card located at the lower edge of the patella and the anterior crest of the tibia) Figure 4 Specification series diagram (comparison of contact spacing for three sizes: children's / adults / obese) Figure 5 Partial sectional view of the functional coupling chamber (showing the angle of the tapered guide bevel and the embedding process of the carrier module). Detailed Implementation

[0009] Example 1: Precise positioning device for Zusanli (ST36)

[0010] Adopting adult standard specifications, the base layer outer diameter is 65mm and the window diameter is 20mm. The contact (210) is a spherical protrusion with a diameter of 8mm, the top of which is 5mm from the base surface, and the material is Shore A75 PVC.

[0011] Operating steps: 1. The subject sits with knees flexed at 90°; 2. Place the device against the anterolateral aspect of the lower leg, with contact point A positioned at the lower edge of the patella and contact point B positioned at the anterior crest of the tibia; 3. Apply 0.5-1N of pressure; a "click" sound indicates successful locking. 4. At this time, the center of the window should be aligned with the surface location point of Zusanli (ST36) (one finger-width lateral to the anterior border of the tibia, 3 inches below Dubi).

[0012] Accuracy verification experiment (n=30):

[0013] The deviation between the center of the window and the actual location of Zusanli (ST36) as determined by ultrasound was measured using a three-dimensional coordinate measuring machine. Average deviation: 1.1mm ± 0.4mm; Maximum deviation: 1.5mm (in accordance with claims); Repeatability: The standard deviation of localization in 5 repeated measurements by the same subject was 0.3 mm; Skin compensation test: simulating knee flexion from 0 to 120°, finite element analysis showed that the radial incision reduced the window center drift from 5.8 mm to 1.2 mm.

[0014] Example 2: Hegu (LI4) Hand Positioning Device

[0015] The hand-shaped design features a 40×30mm oval base with a 28mm contact point spacing to accommodate the length of the second metacarpal bone.

[0016] Card slot design: Contact point A is located on the radial side of the midpoint of the second metacarpal bone (the bony prominence can be felt). Contact point B is positioned in the interosseous space between the first and second metacarpal bones (proximal to the Hegu acupoint);

[0017] Guide bevel optimization experiment: Test the seating response time at bevel angles of 20°, 30°, 40°, and 50°: Bevel angle Average response time (s) Final deviation (mm) 20° 0.78 1.5 30° 0.52 0.9 40° 0.38 0.7 50° 0.45 1.2 The preferred range is 35°-40°, with a response time of 0.35-0.45 seconds and a deviation of ≤0.8mm.

[0018] Example 3: Modular System Combination Application

[0019] Constructing a complete solution of "intelligent rheological control system + mechanical alignment device":

[0020] Operating procedures: 1. Biosignal acquisition → Intelligent system for preparing personalized formulations (as in Example 1); 2. Embed the formulation carrier module into the functional coupling chamber of this device; 3. The mechanical alignment device is positioned at the target surface location point; 4. The carrier module falls into the center of the window under the action of the guide bevel, forming a sealed drug delivery microenvironment.

[0021] Combined effect: Positioning deviation: ±0.8mm (better than 1.5mm for a single device); Permeability CV value: ≤10% (meets clinical reproducibility criteria); Operation time: From medication preparation to application of the patch, less than 3 minutes;

[0022] To achieve standardized application of this device in medical industrial environments, the physical interface between the functional coupling chamber (300) and the carrier module of this invention adopts a Luer taper design conforming to ISO 80369-7 standards, with a nominal taper of 6% and a tolerance strictly controlled within ±0.05mm. This standardized interface design allows for seamless interchangeability between a series of base layers (100) with different contact spacing (adapting to different BMI populations) and the standardized active component carrier module. This combination of "universal interface + self-adaptive base" ensures the physical sealing of the drug delivery microenvironment while greatly improving the standardization and consumable compatibility of this device in clinical operation.

[0023] After airtightness testing, the leakage rate of this interface is <0.5mL / min under a pressure of 0.3MPa, which meets the requirements of YY / T 0148 medical tape standard.

[0024] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention. Any aspects of the present invention not described in detail are common knowledge to those skilled in the art.

Claims

1. A physical alignment device for body surface positioning points with anatomical feature self-adaptation function, characterized in that, include: Base layer (100): Made of medical-grade silicone flexible deformable substrate, with a geometric alignment window (110) with a diameter of 15-25mm in the center. Mechanical limiting component (200): Symmetrically arranged around the periphery of the base layer, including two raised anatomical landmark capture contacts (210), the contacts being configured to generate a perceptible "click" sound feedback under a rated pressure of 0.5-1 N by physically engaging with human bony landmarks or tendon grooves (the contacts have built-in elastic metal sheets, and the sound pressure level is ≥50 dB when the engagement deformation is released), thereby limiting the rotational and translational degrees of freedom of the window on the body surface, so that the deviation of the window center from the target body surface positioning point is ≤±1.5mm; Functional coupling chamber (300): Located above the window, with a 30°-45° conical guide bevel on the inner wall, the surface roughness of the bevel Ra≤1.6μm, for removably embedding a carrier module loaded with active components, and after embedding, the module automatically sits at the geometric center under the action of gravity with a response time of ≤0.5 seconds.

2. The apparatus according to claim 1, characterized in that: The anatomical landmark capture contact (210) is a three-dimensional spherical crown-shaped protrusion with a top curvature radius of 1-3mm. The material is medical PVC with a Shore A hardness of 60-80 degrees, which is 15-30 degrees harder than the base layer (100) to generate differentiated tactile and acoustic feedback when the device is positioned.

3. The apparatus according to claim 1, characterized in that: The base layer (100) is provided with four stress relief cuts (120) distributed at 90°. The cuts extend radially along the window to the edge of the base. The cut width is 0.8-1.2mm. They are used to compensate for the geometric center displacement caused by skin stretching. Finite element analysis has verified that the center deviation is ≤±1.2mm under 30% skin stretching rate.

4. The apparatus according to claim 1, characterized in that: The inner wall conical guide bevel angle of the functional coupling chamber (300) was determined to be 35°-40° through optimization experiments. This angle range can shorten the carrier module's seating response time to 0.35-0.45 seconds and improve the repeatability accuracy to ±0.8mm.

5. A modular body surface positioning point alignment system based on the device of claim 1, characterized in that: It includes three specifications of devices with different contact pitches: children's specification (40mm contact pitch), adult standard specification (60mm contact pitch), and obese specification (80mm contact pitch). Each specification shares the same functional coupling chamber (300) interface standard, and the positioning deviation is ≤1.5mm in the corresponding BMI population through finite element simulation optimization.

6. The application of the physical alignment device for body surface positioning points according to any one of claims 1-4 in the preparation of transdermal drug delivery body surface patch products, characterized in that: The product is a body surface patch device that loads a personalized formulation based on biofeedback signals for adaptive regulation.

7. The system according to claim 5, characterized in that: Each specification of device achieves a series design of contact spacing by adjusting the geometric parameters of the mechanical limit component (200), and the functional coupling compartment (300) adopts a quick-release interface to adapt to different specifications of base layer (100).

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