Preparation method of anatomical attached ice compress bag based on 3D printing of joint three-dimensional model

Abstract

The invention discloses a joint three-dimensional model 3D printing-based dissection fit type ice compress bag preparation method. The method comprises the following steps of S1, three-dimensional data acquisition and male model digital model establishment; s2, 3D printing of a joint male mold prototype: importing the joint male mold digital model into a 3D printer, and printing a solid joint male mold prototype by using rigid photosensitive resin or an ABS (Acrylonitrile Butadiene Styrene) material through an SLA (Stereoscopic Laser Amplification) or FDM (Fused Deposition Modeling) technology; s3, duplicating a silica gel forming female mold: taking the 3D printing joint male mold prototype as a female mold, and manufacturing a female mold by adopting a silica gel casting or injection molding process; s4, forming a silica gel bag body; and S5, post-processing and assembling are carried out. And step S6, assembling. The male mold prototype is rapidly manufactured through the 3D printing technology, the liquid silica gel casting or injection molding technology is combined, large-scale production of three general models of'large, medium and small 'is achieved, then the telescopic structure is assembled to adapt to individual difference adjustment, and the ice compress bag with the personalized attaching effect is formed.

Description

Technical Field

[0001] This invention relates to the field of medical and nursing device technology, and in particular to a method for preparing an anatomically fitting ice pack based on 3D printing of a three-dimensional joint model. Background Technology

[0002] Ice packs are a routine physical therapy method for sports injuries, postoperative swelling reduction, and chronic joint inflammation. Existing ice packs are mostly standardized shapes, which have problems such as poor fit to complex joint surfaces, unstable fixation, uneven cold conduction, skin pressure, and hygiene concerns. Although personalized customization is an option, traditional mold manufacturing is costly and time-consuming, making large-scale production and promotion difficult. Therefore, there is an urgent need for an ice pack solution that can balance personalized fit, mass production, ease of use, and hygiene safety. Summary of the Invention

[0003] The purpose of this invention is to address the aforementioned problems by providing an anatomically fitting ice pack that can closely conform to the complex curved surfaces of human joints, provide stable fixation, offer excellent cryotherapy effects, provide comfortable use, and can be mass-produced, along with its preparation method. It primarily resolves the contradiction between the poor fit of traditional ice packs and the high cost of personalized customization, hindering mass production. Through integrated innovation of "data clustering - 3D printing mold - mass production of silicone," 3D printing technology is used to quickly and cost-effectively manufacture the master mold. Combined with liquid silicone casting or injection molding processes, mass production is achieved, and the fit can be adjusted to accommodate individual differences. This resolves the contradiction between personalized fit and mass production costs for ice packs, resulting in a product with advantages such as excellent fit, secure fixation, and comfortable and hygienic use.

[0004] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0005] On one hand, the present invention provides an anatomically fitted ice pack based on a 3D-printed joint three-dimensional model, comprising the following:

[0006] Silicone bag body: Made of soft medical-grade silicone material, its inner surface is a negative-type fitting surface that matches the anatomical shape of human joints; the negative-type fitting surface refers to a contact surface that is completely complementary to the geometry of the three-dimensional curved surface, generated by reverse engineering based on the three-dimensional curved surface data of the target joint; and the silicone bag body is pre-made into three general-purpose models: large, medium and small, based on the big data clustering analysis of the joint size of the target population.

[0007] Scalable structure: It is set on the outer surface of the side of the silicone bag body. The scalable structure is a telescopic structure that can extend or retract a certain length. The scalable structure can adapt to the size differences and joint movements of different individuals within the same model.

[0008] Inner liner cavity: It is located inside the silicone bag, and the inner liner cavity is equipped with an opening, and the opening of the inner liner cavity is equipped with a sealing cap;

[0009] Waterproof ice pack: It is placed inside the inner cavity; the waterproof ice pack includes a medical-grade TPU film and cold-storage gel particles, and the cold-storage gel medium is heat-sealed inside the medical-grade TPU film.

[0010] On the other hand, the present invention provides a method for preparing the above-mentioned ice pack (anatomical fit ice pack), comprising the following steps:

[0011] Step S1, 3D Data Acquisition and Positive Model Digital Model Establishment: Acquire 3D data of joint parts of the target population, perform cluster analysis based on the database, and design three general-purpose positive models of joints: large, medium, and small.

[0012] Step S2: 3D printing the joint male prototype: Import the above-mentioned joint male digital model into a 3D printer, and use rigid photosensitive resin or ABS material to print a solid joint male prototype using SLA or FDM technology.

[0013] Step S3: Make a silicone molding female mold: Using the 3D printed joint male mold prototype as the master mold, make a female mold using silicone casting or injection molding process;

[0014] Step S4, Silicone Bag Molding: After cleaning the female mold and spraying a release agent, medical-grade liquid silicone material is injected into the cavity of the female mold. After heating and curing, the mold is demolded to obtain a soft silicone bag blank that precisely matches the joint shape.

[0015] Step S5, Post-processing and Assembly: Trim and grind the edges of the silicone bag blank, and install the telescopic structure and inner liner.

[0016] Step S6, Assembly: Place the pre-made waterproof ice pack granules into the inner cavity and close the sealing cap to obtain the ice pack.

[0017] As mentioned above, firstly, massive amounts of personalized joint data are categorized into a limited set of "large, medium, and small" general-purpose models through big data clustering analysis, and a digital model is designed accordingly. Then, 3D printing technology is used to quickly and accurately manufacture a physical male prototype of the joint. This male prototype serves as the source master mold, from which a female mold suitable for mass production is created. Finally, using mature silicone casting or injection molding processes, combined with the female mold, anatomically fitting bags are mass-produced. The stretchable structure on the bag further refines the individual adaptability within the same general-purpose model.

[0018] Based on the aforementioned scheme, in an improved scheme, the method for preparing the anatomically fitting ice pack based on the 3D printing of a joint three-dimensional model further includes step S4: secondary curing at room temperature for 15-30 minutes to optimize performance.

[0019] By adopting the above technical solution, the present invention has the following beneficial effects:

[0020] 1. This invention establishes a joint positive mold digital model based on the three-dimensional joint data of the target population, and quickly manufactures the positive mold prototype through 3D printing technology. Combined with liquid silicone casting or injection molding process, it realizes the large-scale production of three general models: "large, medium and small". Then, it is assembled with a stretchable structure to adapt to individual differences and form an ice pack with personalized fitting effect.

[0021] 2. The detachable and completely waterproof ice pack design of this invention completely eliminates the risk of liquid leakage contaminating the wound and wetting the dressing, making it especially suitable for postoperative patients. Attached Figure Description

[0022] Figure 1 This is a flowchart of Example 1 of the method for preparing the ice pack of the present invention.

[0023] Figure 2 This is a flowchart of Example 2 of the method for preparing the ice pack of the present invention. Detailed Implementation

[0024] The specific implementation of the invention will be further described below with reference to the accompanying drawings.

[0025] As mentioned above, this application includes basic solutions and improved solutions. For example, an improved solution may configure secondary solidification to optimize performance. The feature combinations of each application instance can be combined according to actual needs. The following will use an example of a better combination of all features to illustrate the best application instance.

[0026] The anatomically fitted ice pack based on a 3D-printed joint 3D model of this application includes a bag body (silicone bag body), a stretchable structure, and a detachable waterproof ice pack (waterproof granule pack).

[0027] The bag body is made of soft, medical-grade silicone material, with an inner surface that is a negative-shape conforming surface matched to the anatomical shape of a human joint. Here, "negative-shape conforming surface" refers to a contact surface generated through reverse engineering based on the three-dimensional surface data of the target joint, perfectly complementary to the geometry of that surface. This design aims to maximize the contact area and personalized fit between the ice pack and the joint, thereby improving fit stability and the efficiency of therapeutic medium conduction. The bag body is prefabricated in three universal sizes (large, medium, and small) based on big data clustering analysis of the target population's joint dimensions, and features a stretchable structure on the side edge to accommodate minor individual differences.

[0028] Stretchable structure: Located on the side or other non-adhesive areas of the bag body, it is used to accommodate size differences and joint movements of different individuals within the same model. The stretchable structure, located in a non-adhesive area of ​​the bag body, such as the outer surfaces of both sides, is an accordion pleat or an embedded elastic silicone strip, giving the bag body elastic stretching capabilities to accommodate subtle size differences and joint movements of different individuals within the same model.

[0029] Inner liner: Located inside the bag, its opening is equipped with a sealing cap. The opening is sealed with a waterproof zipper or Velcro.

[0030] A removable, waterproof cooling granule pack is housed within the inner cavity. The cooling granule pack is made of medical-grade TPU film and sealed by high-frequency heat sealing. It is internally encapsulated with a cold-retaining gel medium to ensure complete waterproofing and leak-proofness.

[0031] As mentioned above, see also Figure 1 and Figure 2 The preparation method of the above-mentioned ice pack includes the following steps:

[0032] 1. Data Acquisition and Model Design (Application of Cluster Analysis): Collect and establish a database containing thousands of adult knee joint CT or 3D scan data; use cluster analysis algorithms (such as K-means algorithm) to automatically analyze the key dimensions and shape features of the joints in the database; the algorithm divides the data into three main clusters based on the natural distribution of the data. Calculate the centroid of each cluster or select its most representative sample, ultimately generating three positive digital models of the knee joint: "large," "medium," and "small." This step scientifically summarizes infinitely personalized data into a limited production model.

[0033] 2.3D Printed Joint Positive Mold Prototype (Master Mold for Manufacturing Molds): Select a "medium" digital model and import it into an SLA (stereolithography) 3D printer; using rigid photosensitive resin material, print a 1:1 solid knee joint positive mold prototype with a smooth surface and accurate dimensions. This 3D printed prototype is the source and standard for all subsequent production molds.

[0034] 3. Making production molds (from prototype to production mold):

[0035] Using the 3D-printed resin male mold as the master mold, a silicone female mold with excellent detail replication capabilities is produced by casting and molding using high-strength, high-temperature-resistant silicone. Alternatively, to meet the needs of larger-volume production, this male mold can be used to create a metal female mold through precision casting or other methods.

[0036] 4. Liquid silicone bag molding (core production step):

[0037] a. Clean the silicone mold and spray the release agent evenly.

[0038] b. Precisely measure and mix the two-component addition-cured medical-grade liquid silicone (LSR) according to the predetermined ratio.

[0039] c. Place the mixed silicone into a vacuum chamber to remove air bubbles and ensure the finished product is defect-free.

[0040] d. Smoothly inject the degassed liquid silicone into the prepared negative mold cavity.

[0041] e. Place the mold in an oven or heating plate at 70-80℃ and cure for 20-30 minutes.

[0042] f. Open the mold and carefully remove the silicone bag blank.

[0043] g. (Optional optimization steps, such as...) Figure 1 and Figure 2 (Examples 1 and 2 of the ice pack preparation method) The initial blank of the bag is placed in a room temperature environment for secondary curing for 30 minutes to further improve the mechanical properties and stability of the silicone.

[0044] 5. Post-processing and functional assembly:

[0045] a. Finely trim and polish the initial bag blank, remove burrs from the parting line, and smooth all edges.

[0046] b. Processing the stretchable structure: Using a laser cutting machine, a series of parallel slits are precisely cut into the predetermined non-adhesive areas on both sides of the bag body to form an accordion pleat structure, giving the bag body the ability to stretch and expand laterally.

[0047] c. Using a biocompatible medical-grade silicone adhesive, a soft fabric liner is bonded to the inner layer of the bag to form an inner cavity. At the opening of the inner cavity, a waterproof zipper is bonded or integrally molded as a sealing cap.

[0048] 6. Preparation of waterproof ice pack granules (e.g.) Figure 1 and Figure 2 Examples 1 and 2 of the ice pack preparation method are shown below. This step is an independent process and can be ordered sequentially with the aforementioned steps or performed independently in parallel: A medical-grade TPU film is used to encapsulate a cold-retaining gel medium through a high-frequency heat-sealing process to obtain a sealed and waterproof ice pack granule package. Specifically: A medical-grade TPU film is used to create a sealed small bag through a high-frequency heat-sealing process; cold-retaining gel granules are filled into the bag; and a final heat-sealing is performed to ensure complete waterproofing and leak-proofness, thus creating an independent ice pack granule package.

[0049] 7. Final assembly and use:

[0050] Place the frozen waterproof ice pack granules into the inner cavity of the ice pack and zip it up. Users should choose the appropriate size (large, medium, or small) based on their knee joint size before wearing the product.

[0051] Usage example: For medium-sized products, users should select the medium size based on their knee circumference. Place the frozen pellet pack into the inner liner and zip it up. When worn, the accordion pleats automatically adjust the tightness for an optimal fit. After use, the pellet pack can be easily removed for cleaning and maintenance.

[0052] 8. Product Effects: The soft silicone negative-shape fit surface naturally wraps around the various curves of the knee joint; when worn and bound, the laser-cut accordion pleats on both sides can stretch freely, ensuring even pressure and firm fixation, while also adapting to slight size differences between users of the same model, ultimately achieving excellent anatomical fit and a comfortable user experience.

[0053] As mentioned above, a digital model of the joint's positive mold is established based on the three-dimensional joint data of the target population. A prototype positive mold is then rapidly manufactured using 3D printing technology. Combined with liquid silicone casting or injection molding processes, mass production in three general-purpose sizes (large, medium, and small) is achieved. A stretchable structure is then assembled to accommodate individual differences, creating an ice pack with a personalized fit. The anatomically fitting ice pack manufactured using 3D printing and liquid silicone casting or injection molding processes, along with its preparation method, offers advantages such as excellent fit, secure fixation, high efficiency in cold therapy, hygiene, and wide applicability, as detailed below.

[0054] 1. Achieved "quasi-personalized" efficient mass production: 3D printing technology enables rapid manufacturing of production molds (positive prototypes), overcoming the bottlenecks of high cost and long lead times associated with traditional custom molds. Combined with mature processes such as silicone casting or injection molding, it allows for large-scale production based on "universal models," significantly reducing costs and delivery time, and perfectly balancing fit and economic benefits.

[0055] 2. Wide applicability and high fit: The "three universal models" cover most people, and the "stretchable structure" provides fine-tuning ability. With dual protection, it achieves excellent anatomical fit and stable fixation, and significantly improves the effect of cryotherapy.

[0056] 3. Excellent clinical safety and hygiene: The detachable and completely waterproof ice pack design completely eliminates the risk of liquid leakage contaminating the wound and wetting the dressing, making it especially suitable for postoperative patients. It allows for the separation of the ice pack medium from the bag in contact with the skin, supporting separate cleaning and disinfection, fundamentally solving the risk of cross-infection.

[0057] 4. Convenient to use, economical and environmentally friendly: Users can equip multiple granule packs for alternating freezing, achieving seamless continuous ice application. The granule packs can be replaced individually, extending the service life of the main bag and reducing long-term usage costs, making it environmentally friendly and economical.

[0058] The above description is a detailed explanation and illustration of the preferred embodiments of the present invention. However, these descriptions are not intended to limit the scope of protection claimed by the present invention. All equivalent changes or modifications made under the technical teachings of the present invention should fall within the patent protection scope covered by the present invention.

Claims

1. An anatomically fitting ice pack based on a 3D-printed joint three-dimensional model, characterized in that, Includes the following: Silicone bag body: Made of soft medical-grade silicone material, its inner surface is a negative-shape conforming surface that matches the anatomical shape of human joints; The negative contact surface refers to a contact surface that is completely complementary to the geometry of the three-dimensional surface, generated by reverse engineering based on the three-dimensional surface data of the target joint; and the silicone bag is prefabricated into three general-purpose models: large, medium, and small, based on big data cluster analysis of the joint size of the target population. Scalable structure: It is set on the outer surface of the side of the silicone bag body. The scalable structure is a telescopic structure that can extend or retract a certain length. The scalable structure can adapt to the size differences and joint movements of different individuals within the same model. Inner liner cavity: It is located inside the silicone bag, and the inner liner cavity is equipped with an opening, and the opening of the inner liner cavity is equipped with a sealing cap; Waterproof ice pack: It is placed inside the inner cavity; the waterproof ice pack includes a medical-grade TPU film and cold-storage gel particles, and the cold-storage gel medium is heat-sealed inside the medical-grade TPU film.

2. The anatomically fitting ice pack based on a joint 3D model 3D printing according to claim 1, characterized in that: The retractable structure is an accordion pleat structure to accommodate joint movement and size differences between different individuals within the same general model; the accordion pleat structure is formed by laser cutting on the outer surface of the silicone bag.

3. The anatomically fitting ice pack based on a joint 3D model 3D printing according to claim 1, characterized in that: The retractable structure is an embedded elastic silicone strip to accommodate joint movement and size differences between different individuals within the same general model; The embedded elastic silicone strip is heat-sealed to the outer surface of the silicone bag body using medical silicone adhesive.

4. The anatomically fitting ice pack based on a joint 3D model 3D printing according to claim 1, characterized in that: The sealing cap is a waterproof zipper or Velcro.

5. A method for preparing an anatomically fitting ice pack as described in any one of claims 1-4, characterized in that, Includes the following steps: Step S1, 3D data acquisition and positive mold digital model establishment: acquire 3D data of joint parts of the target population, perform cluster analysis based on the database, and design three general-purpose positive mold digital models of joints: large, medium and small. Step S2: 3D printing the joint male prototype: Import the digital model of the joint male into a 3D printer, and use rigid photosensitive resin or ABS material to print a solid joint male prototype using SLA or FDM technology. Step S3: Making a silicone molding female mold: Using the 3D printed joint male mold prototype as the master mold, a female mold is made by silicone casting or injection molding process. Step S4, Silicone Bag Molding: After cleaning the negative mold and spraying a release agent, medical-grade liquid silicone material is injected into the cavity of the negative mold. After heating and curing, the mold is demolded to obtain a soft silicone bag blank that precisely matches the joint shape. Step S5, Post-processing and assembly: Trim and polish the edges of the silicone bag blank, and install the telescopic structure and the inner liner. Step S6, Assembly: Place the pre-made waterproof ice pack granules into the inner cavity and close the sealing cap to obtain the ice pack.

6. The method for preparing the anatomically fitting ice pack according to claim 5, characterized in that: In step S4, medical-grade liquid silicone material is mixed with two-component addition-type liquid silicone in a certain proportion and degassed under vacuum. Then, it is injected into the cavity under constant pressure and heated and cured at 60-80°C for 15-30 minutes.

7. The method for preparing the anatomically fitting ice pack according to claim 6, characterized in that: Step S4 further includes: performing a secondary curing at room temperature for 15-30 minutes.

8. The method for preparing the anatomically fitting ice pack according to claim 5, characterized in that: In step S6, the manufacturing process of the waterproof ice pack is as follows: a medical-grade TPU film is used, and a cold-storing gel medium is encapsulated through a high-frequency heat sealing process to obtain a sealed waterproof ice pack.

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