Stoma insert based on laser scanning technology

Abstract

The utility model relates to the field of medical instruments, in particular to a stoma insert based on a laser scanning technology, which comprises a mold, a stoma insert and a stoma bag, the mold comprises a peripheral, convex and circumferentially extending skirt part, the skirt part limits the outer boundary of the finally molded stoma insert, and the internal cross section of the skirt part is an opening of the stoma bag. The stoma insert comprises a lantern ring and a stoma insert core, an offset hole penetrates between the lantern ring and the stoma insert core, the surface of the mold is provided with protrusions and stripe areas, and the areas generate complementary shadow lines, nicks or stripe surfaces on the skin contact face of the stoma insert. This not only contributes to guiding sweat, sebum and other body fluids away from the stoma, but also contributes to keeping the surrounding skin dry, providing sufficient support force. Meanwhile, the surface smoothness can be further optimized, for example, the functionality and comfort of the stoma insert are improved by smoothing the surface or coating a non-sticky or low-sticky compound through a chemical vapor process.

Description

Technical Field

[0001] The utility model relates to the field of medical appliances, in particular to a stoma insert based on laser scanning technology. Background Art

[0002] 3D laser scanning technology is also known as real-scene replication technology. As a high-tech technology that began to appear in the mid-1990s, it uses high-speed laser scanning measurement methods to quickly obtain the (xyz) coordinates, reflectivity, (RGB) color and other information of each point on the surface of an object over a large area and with high resolution. These large amounts of dense point information can quickly reconstruct a 1:1 true-color 3D point cloud model, providing an accurate basis for subsequent internal processing, data analysis and other work. 3D laser scanning technology can provide 3D point cloud data on the surface of the scanned object, so it can be used to obtain high-precision and high-resolution digital morphological models. Through high-speed laser scanning measurement methods, the 3D coordinate data of the surface of the measured object and a large amount of spatial point information can be quickly obtained over a large area and with high resolution. It is a new technical means to quickly establish a 3D image model of an object. 3D laser scanning technology makes the application of big data possible in many industries.

[0003] A stoma is an opening formed naturally or surgically in the abdominal wall of the human body for defecation or urination. After stoma surgery, patients cannot control the excretion of feces or urine due to the loss of sphincter control function, so they need to use stoma products to assist in collecting excrement. The most important form of artificial stoma is colostomy, which is an opening formed by surgery in the large intestine that allows feces or other excreta to bypass the rectum and be discharged into a stoma bag or other collection device. This surgery forms a stoma by pulling the healthy end of the colon through an incision in the anterior abdominal wall and suturing it in place. The opening, together with the attached stoma appliance, provides an alternative channel for feces or other excreta to leave the body. However, because the uniform structure of the stoma device does not match the patient's personalized body morphology, it often leads to fecal overflow, odor escape, and inflammation of the surrounding skin between the stoma and the stoma device, causing physical and mental pain and economic pressure to the patient. Utility Model Content

[0004] 1. Technical issues to be resolved

[0005] In view of the deficiencies of the prior art, the utility model provides a stoma insert based on laser scanning technology.

[0006] (II) Technical solution

[0007] To achieve the above-mentioned purpose, the utility model provides the following technical solutions: a ostomy insert based on laser scanning technology, comprising a mold, a ostomy insert and an ostomy bag, the mold comprising a peripheral, raised, circumferentially extending skirt, the skirt defining the outer boundary of the final molded ostomy insert, and the internal cross-section being the opening of the ostomy bag, the ostomy insert comprising a collar and a ostomy insert core, an offset hole extending between the collar and the ostomy insert core, the bottom of the collar being a skin contact surface, the mold further comprising a central, substantially upright column, the shape and size of the cross-sectional diameter of which are larger than those of the final molded ostomy insert, the surface of the mold being provided with raised and striped areas, the ostomy insert being used to fix the ostomy bag, and the molding material of the mold being a 3D printing material.

[0008] Preferably, the material of the stoma insert is any one of natural rubber, latex, chloroprene rubber, polyvinyl chloride, nitrile, synthetic polymer, synthetic resin, synthetic rubber and acrylic polymer, and the stoma insert is a transparent structure.

[0009] It is further preferred that the stoma insert is coated with an antimicrobial compound.

[0010] Again preferably, the stoma insert is coated with an anti-inflammatory, antipyretic and analgesic compound, including any one of acetylsalicylic acid, ibuprofen, fenbuprofen, fenoprofen, flurbiprofen, indomethacin, ketoprofen and naproxen.

[0011] Preferably, the ostomy insert is coated with a deodorant compound.

[0012] It is further preferred that the ostomy insert is coated with an antiperspirant compound.

[0013] Again preferably, the stomal insert is coated with a low tack, physiologically acceptable adhesive.

[0014] (III) Beneficial effects

[0015] Compared with the prior art, the utility model provides a stoma insert based on laser scanning technology and a processing method and a use method thereof, which have the following beneficial effects:

[0016] 1. Precise fit and comfortable experience: Through laser scanning technology, the mold can accurately replicate the shape and size of the patient's stoma and the surrounding skin area. This allows the stoma insert to fit closely to the patient's stoma and surrounding skin during assembly, providing sufficient support while keeping the skin dry and improving the patient's comfort;

[0017] 2. Rapid customization and convenience: The mold is made of 3D printing materials, which are easy to obtain and have a short production cycle. After receiving the scan data of the patient's stoma and surrounding skin area, a customized stoma insert can be created in a short time, meeting the needs of rapid customization and convenience;

[0018] 3. Optimize surface treatment and functionality: The mold surface is provided with raised and striped areas, which produce complementary shadow lines, notches or striped surfaces on the skin contact surface of the stoma insert. This not only helps to guide sweat, sebum and other body fluids away from the stoma, but also helps to keep the surrounding skin dry and provide adequate support. At the same time, the surface finish can be further optimized, such as smoothing the surface through chemical vapor processes or coating non-stick or low-stick compounds, which improves the functionality and comfort of the stoma insert.

[0019] 4. Drug addition and therapeutic effect: Stoma inserts can be impregnated or coated with drugs or medical compounds such as antimicrobial compounds, anti-inflammatory compounds, antiperspirant compounds, etc. The addition of these compounds can not only prevent the growth and spread of harmful microorganisms, but also relieve inflammation, control sweating, and mask body odor. At the same time, drugs or medical compounds can be absorbed through the intestinal mucosa to achieve the effect of sustained-release preparations, improving the therapeutic effect and the quality of life of patients;

[0020] 5. Choice of one-piece or non-one-piece molding: The ring and the stoma insert core in the stoma insert can be molded in one piece or in a non-one-piece manner. This design flexibility allows the stoma insert to better adapt to the needs and preferences of different patients, improving applicability and comfort;

[0021] In summary, the stoma insert based on laser scanning technology and its processing method and use method have many beneficial effects such as precise fitting, rapid customization, optimized surface treatment, material diversity, drug addition, and selection of integral and non-integrated molding. These effects jointly improve the applicability, comfort and therapeutic effect of the stoma insert, bringing better use experience and quality of life to patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a top view of the mold manufactured according to the utility model;

[0023] Figure 2 It is a three-dimensional view of the mold manufactured according to the utility model;

[0024] Figure 3 When following Figure 1 A cross-sectional view of a mold manufactured according to the utility model when observed in cross section;

[0025] Figure 4 is a three-dimensional view of a stoma insert according to the present invention;

[0026] Figure 5 is a schematic diagram of the stoma insert according to the utility model being assembled to the stoma of a patient;

[0027] Figure 6 is a schematic diagram of the stoma insert according to the utility model when installed in the stoma of a patient;

[0028] Figure 7 is a schematic diagram of a stoma insert according to the present invention, with a schematic diagram of an stoma bag mounted thereon;

[0029] In the figure: 1, mold; 2, skirt; 3, column; 4, surface; 5, ring; 6, offset hole; 7, stoma insert core; 8, stoma insert; 9, skin contact surface; 10, stoma bag. DETAILED DESCRIPTION

[0030] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0031] See also Figure 1-7 The stoma insert based on laser scanning technology of the utility model comprises a mold 1, a stoma insert 8 and a stoma bag 10, wherein the mold 1 comprises a peripheral, raised, circumferentially extending skirt 2, wherein the skirt 2 defines the outer boundary of the final molded stoma insert 8, and the internal cross-section is the opening of the stoma bag 10, the stoma insert 8 comprises a collar 5 and a stoma insert core 7, an offset hole 6 is penetrated between the collar 5 and the stoma insert core 7, the bottom of the collar 5 is a skin contact surface 9, the mold 1 also comprises a central, substantially upright column 3, the shape and size of the cross-sectional diameter of which are larger than those of the final molded stoma insert 8, the surface 4 of the mold 1 is provided with raised and striped areas, the stoma insert 8 is used to fix the stoma bag 10, and the molding material of the mold 1 is a 3D printing material.

[0032] The method of using the utility model comprises the following steps:

[0033] Step 1, molding of the stoma insert 8: casting or molding the stoma insert 8 in the mold 1 using a molding material. The stoma insert core 7 and the collar 5 may be molded integrally or non-integrally as required.

[0034] Step 2, optimizing the surface 4 treatment: As required, the surface 4 finish of the mold 1 can be optimized by smoothing the surface 4 using a chemical vapor process or coating it with a non-stick or low-stick compound.

[0035] Step 3: Assembly and use: After molding is completed, the stoma insert 8 is assembled to the patient's stoma. According to the design of the mold 1, the insert will fit closely to the patient's stoma and surrounding skin area, providing sufficient support while keeping the skin dry.

[0036] In summary, the stoma insert 8 based on the laser scanning technology, when the stoma insert 8 is removed from the mold 1, the stoma insert 8 defines a central or offset hole 6, and fluid flow can be achieved inside.

[0037] The mold 1 is shaped to provide an accurate mirror image of the stoma and the skin area around the stoma for the patient, so that when the stoma insert 8 is assembled to the stoma of the patient, the stoma and the surrounding skin of the patient can be tightly sucked together.

[0038] The mould 1 uses readily available materials for 3D printing, which means that a custom-made stoma insert 8 can be created within a few hours of receiving scan data of the patient's stoma and surrounding skin area.

[0039] The mold 1 includes raised or striped areas on its surface 4 which, when the stoma insert 8 has been molded, produce a complementary shaded, scored or striped surface 4 on the skin contacting surface 9 of the stoma insert 8, helping to direct sweat, sebum and other body fluids (not shown) away from the stoma and helping to keep the surrounding skin dry and provide adequate support.

[0040] In the present invention, the surface 4 finish can be optimized by using a chemical vapor process, and the surface 4 stripes can be smoothed or coated with a non-stick or low-stick compound such as polytetrafluoroethylene.

[0041] Similar to the stoma insert core 7, the shape and size of the circumferentially extending collar 5 of the final molded stoma insert 8 is designed to closely follow the contours of the patient's peri-stoma skin area, thereby ensuring a snug or light pressure suction fit between the stoma insert and the stoma.

[0042] The stoma insert core 7 and the collar 5 can be molded as one piece, i.e. in an integral manner, but in most cases, the stoma insert core 7 and the collar 5 are molded from two different materials, i.e. in a non-integrated manner. In the non-integrated manner, the stoma insert core 7 and the collar 5 are both made of moldable materials with different physical and chemical properties, so that the stoma insert core 7 can be made of a more flexible and elastic material. Therefore, the stoma insert core 7 is tighter in the stoma and has a better fit, while the harder outer collar 5 has sufficient elasticity to firmly fix the stoma bag 10 near the stoma.

[0043] The stoma insert is typically cast, formed or molded in the mold 1 using silicone rubber, but may also use natural rubber, latex, neoprene, polyvinyl chloride, nitrile, synthetic polymers, synthetic resins, synthetic rubbers, acrylic-based polymers or any mixture thereof.

[0044] The stoma insert 8 may be impregnated or coated with an antimicrobial compound which may be selected from any one or more or naturally occurring, elemental or synthetic antimicrobial compounds, such as antibacterial, bacteriostatic, bacteriolytic, antiviral or antifungal compounds, including silver salts or ions.

[0045] At least a portion of the stoma insert 8 is coated with a bacteriostatic agent, in particular, capable of binding and isolating currently multi-drug resistant microorganisms.

[0046] The stoma insert can be impregnated or coated with an anti-inflammatory, antipyretic or analgesic compound, such as a nonsteroidal anti-inflammatory drug ("NSAID"), which can be selected from any one or more naturally occurring or synthetic NSAID compounds, including: acetylsalicylic acid, ibuprofen, fenbuprofen, fenoprofen, flurbiprofen, indomethacin, ketoprofen, naproxen, etc. In certain embodiments, an anti-rash cream or barrier cream, typically containing zinc, can be used with, incorporated into, or impregnated into the stoma insert to help heal and protect the skin.

[0047] The antimicrobial agent content of the stoma insert reaches 0.01%-5% of the total weight, which has an effective antimicrobial effect not only on the surface 4 of the insert, but also on the surface 4 that the insert contacts. Therefore, it not only prevents harmful microbial entities from being transferred from the insert to the contacted skin surface 4 or stoma wall, but also the microbial entities on the surface 4 can be effectively eliminated after contact.

[0048] The stoma insert may be impregnated or coated with one or more deodorant compounds.

[0049] The stoma insert 8 may be coated or impregnated with a low tack, physiologically acceptable adhesive, which may aid in positioning the insert into the stoma or surrounding area.

[0050] The stoma insert may also be coated or impregnated with an antiperspirant compound to control perspiration beneath the stoma insert and to mask body odor produced by sweat or sebum secretions from the peristomal skin covered by the stoma insert.

[0051] Deodorants, anti-inflammatory agents, adhesives, antiperspirants or antimicrobial compounds and antibodies can be mixed with the moldable material or can be fused (usually heat fused) to the custom insert during manufacturing. In another aspect of the invention, the deodorant, antibody, antimicrobial compound can be applied to the mold 1 so that the compound is transferred to the insert during the molding process.

[0052] Because many drugs or medical compounds are absorbed through the intestinal mucosa, when drugs or medical compounds are added, they can be impregnated or coated in the mucosa of tissues near the stoma. Therefore, the suppository sustained-release preparation is released from the stoma insert after adding the antimicrobial agent.

[0053] The stoma insert 8 may be made of an opaque material on one side and a transparent material on the other side so that the skin around the stoma is visible through the insert, allowing a caregiver to observe the stoma insert 8 and determine whether the skin is inflamed or otherwise damaged or pathological.

[0054] When the ostomy bag 10 is assembled on a patient, the ostomy insert 8 is first installed on the patient's body, and then a corresponding connecting device is provided to fix the ostomy bag 10. Before installing the ostomy bag 10, a leak-proof agent should be applied around the stoma.

[0055] The processing method of the utility model comprises the following steps:

[0056] Step 1: CT scan obtains overall information of the human body and locates the affected area;

[0057] Step 2: 3D laser scanning of the area where the stoma insert 8 is manufactured;

[0058] Step 3: 3D modeling is performed on the scan data obtained by 3D scanning to render the stoma and surrounding skin contours, and the modeling data is preprocessed to make the scan data suitable for use in a manufacturing environment;

[0059] Step four: creating a mould 1 for the stoma insert 8 such that the mould 1 provides complementary surfaces 4 that closely reflect the contours of the stoma and surrounding skin area;

[0060] Step five: producing a stoma insert 8 by pouring a physiologically acceptable moldable material into the mold 1, allowing the moldable material to cure to a desired hardness, and removing the customized stoma insert 8 from the mold 1, wherein the shape and size of the resulting customized stoma insert 8 are determined to ensure a close fit within the stoma and on the skin around the stoma.

[0061] Laser scanning technology can use commercially available pulsed 3D laser scanners, such as: Z+F, Leica (Germany), Surphaser, FARO Focus S, Trimble (USA), I-site, Maptek (Australia), Riegl (Austria), Hexagon (Sweden), Optech, Creaform (Canada), Topcon (Japan), Artec Leo (Russia), Xintuo (China) and other manufacturers to complete the collection and organization of on-site data, usually through high-resolution scanning slices with a thickness of 2 mm or thinner. The scanning process is performed to create a point cloud of the geometric sample of the stoma and the patient's surrounding skin surface 4. These points can then be used to infer the shape of the stoma and the surrounding skin area for 3D printing of the mold 1 of the stoma insert.

[0062] The positioning of the affected area relies on the routine use of 64-row and above CT scans + 3D imaging in Chinese medical institutions;

[0063] In one embodiment of the present invention, the post 3 on the mold 1 can be slightly larger than the stoma into which the stoma insert 8 is to be installed, so that when the stoma insert 8 is removed from the mold 1, it defines a center hole with a cross-sectional diameter similar to or slightly larger than the cross-sectional diameter of the stoma, thereby ensuring a slight friction fit or slight interference fit between the stoma insert 8 and the stoma.

[0064] In certain embodiments, the mould 1 does not comprise the post 3 and the resulting stoma insert 8 is in the form of a blind plug, which may be used to reduce the protrusion of the stoma.

[0065] The mould 1 may have a cross-sectional diameter similar to or slightly larger than the opening of the ostomy bag 10 to be mounted to the ostomy insert 8, so that the ostomy bag 10 remains proximal to the stoma with minimal discomfort to the patient.

[0066] As used herein, the term "antimicrobial compound" refers to any naturally occurring, elemental, synthetic or semi-synthetic compound or a combination or mixture thereof. Antibiotics are preferably used herein, and antibiotics can generally be divided into the following categories according to their chemical composition: aminoglycosides, such as gentamicin, neomycin, kanamycin and streptomycin; macrolides, such as erythromycin, clindamycin and rifampicin; penicillins, such as penicillin G, penicillin V, ampicillin and amoxicillin; polypeptides, such as bacitracin and polymyxin; tetracyclines, such as tetracycline, chlortetracycline, oxytetracycline and doxycycline; cephalosporins, such as cephalexin and cephalothin; quinolones, such as ciprofloxacin, norfloxacin and ofloxacin; and various antibiotics such as chloramphenicol and clindamycin.

[0067] Other antimicrobial compounds useful herein include sulfonamides; nitrofurans, such as nitrofuranazine, nitrofurantoin, and furazolidone; metronidazole, tinidazole, and nimorazole.

[0068] Penicillin, erythromycin, metronidazole, doxycycline, metronidazole, amoxicillin, ampicillin, tetracycline, nitrofurantoin and mixtures thereof are preferred antimicrobial agents for use in the present invention.

[0069] Other antimicrobial agents suitable for the ostomy insert 8 of the present invention include silver salts, biguanides, chlorhexidine salts, dextran sulfate, quaternary ammonium salts, benzalkonium, acriflavine, acridinium dyes, gentian violet, mercurochrome, blue-green algae extracts, or any mixture thereof, with a total mass within 5% of the insert, which can prevent harmful microbial entities from being transferred from the insert to the patient's skin in contact with it.

[0070] The antimicrobial agent may be administered in a single daily dose under the method of the present invention, or in two, three, four or more doses per day, with any drug to be absorbed into the body being applied to or impregnated into the stoma insert core 7 and also into the collar 5 .

[0071] As used herein, the term "NSAID" refers to any agent having anti-inflammatory, antipyretic and / or analgesic properties. Specific NSAIDs that can be used in the present invention include, but are not limited to: oxicams, such as piroxicam, isoxicams, tenoxicam, sudoxicam and CP-14,304; salicylates, such as acetylsalicylic acid, disalcid, benorylate, trilisate, safapryn, solplrin, diflunisal and fendol; acetic acid derivatives, such as diclofenac, fenclofenac, indomethacin, sulindac, tolmetin, isoxicams ... The invention relates to NSAIDs such as oxypaque, furofenac, thiophenac, zidometacin, acemacin, fenthiazide, zomelat, cleridacid, oseltaminic acid and felbinac; fenamates such as mefenamic acid, meclofenamic acid, flufenamic acid, niflumic acid and tolfenamic acid; propionic acid derivatives such as ibuprofen, naproxen, benoprofen, flurbiprofen, ketoprofen, fenoprofen, fenbufen, indoprofen, pirprofen, carprofen, oxaprozin, pranoprofen, miloprofen, tioxaprofen, suprofen, almiprofen and thiaprofen; and pyrazoles such as phenylbutazone, oxyphenylbutazone, fepiridone, azapoxetine and trimethoprim. Mixtures of these NSAIDs can also be used, as well as pharmaceutically acceptable salts and esters of these drugs.

[0072] The present invention can also use another type of non-steroidal anti-inflammatory compound, which includes a specific substituted phenyl compound, especially a substituted 2,6-di-tert-butylphenol derivative, for example, a compound selected from 4-(4'-pentyn-3'-one)-2,6-di-tert-butylphenol; 4-(5'-hexynyl)-2,6-di-tert-butylphenol; 4-((S)-(-)-3'-methyl-5'-hexynyl)-2,6-di-tert-butylphenol; 4-((R)-(+)-3'-methyl-5'-hexynyl)-2,6-di-tert-butylphenol; 4-(3',3'-dimethoxypropionyl)-2,6-di-tert-butylphenol can be used in the present invention. Preferred examples of NSAIDs include, but are not limited to, acetylsalicylic acid, ibuprofen, fen-ibuprofen, fenoprofen, flurbiprofen, indomethacin, ketoprofen, naproxen, their pharmaceutically acceptable salts, their enantiomers, and mixtures thereof. Ibuprofen, indomethacin, acetylsalicylic acid and naproxen are particularly preferred for use in the present invention.

[0073] It should be understood that the terms used above are for descriptive purposes and should not be regarded as limiting. The described embodiments are intended to illustrate the present invention rather than to limit the scope of the present invention. The present invention can be improved at any time through various modifications and additions based on the technological development achievements in the field.

[0074] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A stoma insert based on laser scanning technology, characterized in that, The invention comprises a mould (1), a stoma insert (8) and a stoma bag (10), wherein the mould (1) comprises a peripheral, raised, circumferentially extending skirt (2), wherein the skirt (2) defines the outer boundary of the final moulded stoma insert (8), and the inner cross section is the opening of the stoma bag (10), wherein the stoma insert (8) comprises a collar (5) and a stoma insert core (7), wherein an offset hole (6) passes through the collar (5) and the stoma insert core (7), wherein the bottom of the collar (5) is a skin contact surface (9), wherein the mould (1) further comprises a central, substantially upright column (3), wherein the shape and size of the cross-sectional diameter thereof are larger than those of the final moulded stoma insert (8), wherein the surface (4) of the mould (1) is provided with raised and striped areas, wherein the stoma insert (8) is used to fix the stoma bag (10), and wherein the moulding material of the mould (1) is a 3D printing material.

2. The stoma insert based on laser scanning technology according to claim 1, characterized in that The material of the stoma insert (8) is any one of natural rubber, latex, chloroprene rubber, polyvinyl chloride, nitrile, synthetic polymer, synthetic resin, synthetic rubber and acrylic polymer, and the stoma insert (8) is a transparent structure.

3. The stoma insert based on laser scanning technology according to claim 2, characterized in that The stoma insert (8) is coated with an antimicrobial compound.

4. The stoma insert based on laser scanning technology according to claim 3, characterized in that The stoma insert (8) is coated with an anti-inflammatory, antipyretic and analgesic compound, including any one of acetylsalicylic acid, ibuprofen, fenbuprofen, fenoprofen, flurbiprofen, indomethacin, ketoprofen and naproxen.

5. The stoma insert based on laser scanning technology according to claim 4, characterized in that The stoma insert (8) is coated with a deodorant compound.

6. The stoma insert based on laser scanning technology according to claim 5, characterized in that The ostomy insert (8) is coated with an antiperspirant compound.

7. The stoma insert based on laser scanning technology according to claim 6, characterized in that The stoma insert (8) is coated with a low-tack, physiologically acceptable adhesive.

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