Medical adhesive applicator

Abstract

The utility model discloses a medical adhesive applicator, and relates to a medical adhesive applying device packaged by a glass ampoule bottle. The medical adhesive applicator comprises a sealing head, an applying head, a bottle plug, a filter element, an ampoule bottle and an applying bottle. Compared with an ampoule tube, the packaging type of the ampoule bottle is higher in yield, the reject ratio of products caused by the production process is reduced, and meanwhile, due to the glass fragment filtering design of the applicator, glass fragments which cannot be observed by naked eyes are completely filtered and cannot reach the wound of a patient. And in the economic aspect, different from the ampoule tube packaging type, the small effective usage amount and the high reject ratio are adopted, the actual usage amount of the product is greatly improved by about 40%, the production efficiency and the qualified rate of the product are greatly improved, and the economic benefit is obvious.

Description

Technical Field

[0001] The utility model relates to a medical adhesive coating device, in particular to a medical adhesive coating device packaged in a glass ampoule bottle. Background Art

[0002] Medical adhesives are emerging medical products that replace postoperative sutures and provide a new method for postoperative tissue repair. The main component of the widely used medical adhesives is α-cyanoacrylate, which has the characteristics of fast curing time and high closure strength. The packaging of medical adhesives used in clinical surgery today is mostly glass ampoules filled and sealed to maximize the shelf life of medical adhesive products.

[0003] While using glass ampoules to package medical adhesive products improves product performance stability, there are also some problems during use in clinical surgery. For example, the medical adhesive product produced and sold by Guangzhou Baiyun Medical Adhesive Co., Ltd. under the trade name "Baiyun Medical Adhesive" is used in the traditional way of directly breaking the ampoule and using a disposable dropper to absorb the adhesive inside the ampoule and apply it to the wound surface. This operation method is not conducive to the uniform application of the adhesive on the wound surface, and the wound sealing effect is difficult to ensure. In addition, the secondary absorption of the adhesive can easily cause contamination and denaturation of the product in the ampoule. At the same time, the glass fragments of the ampoule that are not easy to observe with the naked eye may fall into the adhesive in the ampoule, which poses certain safety risks during use. Another product produced and sold by Johnson & Johnson of the United States is The product named "Dermabond" is a medical adhesive product. It simplifies the steps of using the product. During the use of this type of device, it is only necessary to squeeze the middle of the applicator to break the ampoule tube and then directly apply it to the wound. This operation method is relatively convenient to use, but in actual operation, it is difficult to break the ampoule tube. The wound application operation requires the user to press hard to squeeze out the adhesive. During the application process, the direct contact between the adhesive outlet and the wound is likely to cause blockage of the outlet, and there is a risk of interruption during the operation. In addition, the glass fragments will absorb a certain amount of adhesive, reducing the actual use of the product, and the economic benefits are not good. In order to facilitate the crushing of the ampoule tube, the wall thickness of the ampoule tube is required to be thin, but the current domestic ampoule tube production process needs to be improved. At present, the ampoule tubes produced by most manufacturers are difficult to meet the thin-wall requirements, and the product transportation damage rate is high. Correspondingly, there is a lack of dedicated ampoule tube automatic packaging equipment on the market. Based on the above reasons, in the production process of ampoule tube flame melting and sealing, it is easy to cause packaging failure due to the quality of the ampoule tube and the packaging equipment, so the ampoule tube packaging process has great economic costs and safety hazards. Summary of the invention

[0004] In view of the problems existing in the existing products of this type, the utility model aims to provide a fast and efficient medical device, and in particular to a medical adhesive coating device, so as to solve the problems of inconvenience in using or low effective usage, low production efficiency and low pass rate of medical adhesives packaged in traditional glass ampoules or ampoule tubes.

[0005] The medical adhesive applicator described in the utility model comprises a sealing head 6, an applicator head 5, a bottle stopper 4, a filter element 3, an applicator bottle 2, and an ampoule bottle 1. The applicator bottle 2 is a hollow cylinder with through holes at both ends, the distal end of the cylinder is connected to the ampoule bottle, and the proximal end of the cylinder is connected to the bottle stopper. The bottle stopper 4 is a hollow cylinder with through holes at both ends, the distal end is connected to the proximal end of the applicator bottle, and the proximal end is connected to the distal end of the applicator head. The applicator head 5 is a hollow cylinder with through holes at both ends, and the proximal end is connected to the sealing head 6, and the sealing head 6 blocks the proximal through hole of the applicator head. The inner diameter of the distal end 2-1 of the applicator bottle 2 and the outer diameter of the ampoule bottle are assembled and sealed by interference fit, and the proximal end 2-2 and the distal end 4-1 of the bottle stopper are assembled and sealed by interference fit; the filter element 3 and the distal end 4-2 of the bottle stopper are interfered to achieve the functions of assembly and filtering; the sealing structure 6-1 of the sealing head and the adhesive outlet part 5-3 of the applicator head are assembled and blocked by interference fit.

[0006] The medical adhesive applicator described in the utility model is a sealed ampoule bottle 1 that is assembled on the distal end 2-1 of the applicator bottle after the bottleneck is broken off. The applicator bottle 2 is squeezed to displace the adhesive in the ampoule bottle with air, so that the adhesive fills the proximal end 2-2 of the applicator bottle. The sealing head 6 is manually removed from the applicator head 5, and the proximal end 2-2 of the applicator bottle is squeezed to make the adhesive flow through the bottle stopper and the applicator head, and finally applied to the patient's wound area through the outlet portion 5-3 and the application surface 5-4 of the applicator head.

[0007] The medical adhesive applicator described in the utility model has an ampoule bottle 1 which is a hollow structure with two ends sealed. The bottle opening method is to manually or with the aid of other tools to break the bottleneck so that one end is open and the other end is sealed. When in use, the open end is assembled to the gradient assembly position 2-1-1 at the far end of the smear bottle. The gradient assembly position 2-1-1 at the far end of the smear bottle is a variable diameter design. According to the actual size of the ampoule bottle, the inner diameter of the smear bottle is designed to be two or more sizes. Different inner diameters are matched for ampoule bottles of different sizes within the tolerance range. The gradient assembly position 2-1-1 and the ampoule bottles within the tolerance range of 0.3mm can ensure that the assembly interference is within the range of 0.1~0.6mm. At the same time, the assembly belt width of the ampoule bottle and the smear bottle is designed to be 2~8mm to ensure assembly sealing and manual assembly operability.

[0008] The medical adhesive applicator of the utility model has a certain elasticity, and can be deformed by pressing with fingers, and the deformation effect is positively correlated with the pressure. The shape of the applicator can be designed as a cylinder, a square cylinder, an elliptical cylinder, etc. The material used for the applicator is preferably LDPE, which can maintain a suitable elastic deformation while ensuring overall support, and is the most reasonable material choice confirmed in the case of testing and evaluating multiple materials.

[0009] The integrated design of the medical adhesive applicator of the utility model facilitates clinicians to control the amount and uniformity of adhesive applied on the wound.

[0010] The material of the filter element 3 described in the utility model is preferably high-density polyethylene, which has low cost and good filtering effect, and can completely filter out impurities in the medical adhesive and ampoule bottle debris, but the material selection of the filter element is not limited; the shape of the filter element can be bullet-shaped, cylindrical, conical, spherical, elliptical, etc.

[0011] The filter element 3 described in the present invention can be a single filter element without any additives, or a composite filter element loaded with one or more trace additives including but not limited to thickeners, plasticizers, curing accelerators, and wound healing promoters. By adding the load, the adhesive can absorb the load when flowing through the filter element, thereby achieving the specific design function, such as accelerating the curing film formation time of the adhesive on the wound surface.

[0012] The application head described in the utility model is made of silicone material, has good elasticity, can fully contact with the patient's wound, and is convenient for applying the adhesive. The structure of the application head is designed so that the adhesive outlet is separated from the application surface of the application head and is not on the same plane. The application surface is designed as a plurality of columnar structures to separate the two in space. The inclination angle of the application head can be any angle between 30-60°, preferably 40°, which is in line with the usage habits of most surgical operators, thereby improving the adhesive application effect and making the adhesive on the wound surface more uniform.

[0013] The filter element 3 of the medical adhesive applicator described in the utility model plays the role of filtering the debris of the ampoule bottle, and has a significant improvement in safety compared with other existing designs without the filter element filtering function. In the process of breaking the ampoule bottle, tiny debris that cannot be observed by the naked eye will fall into the medical adhesive. As the medical adhesive is applied to the skin wound, it will adhere to the wound surface, affecting the healing of the wound and posing the risk of adverse reactions after surgery.

[0014] The medical adhesive applicator described in the utility model is used by squeezing the applicator bottle 2, and the air is squeezed into the ampoule bottle 1 through deformation to replace the medical adhesive therein into the applicator bottle 2. Compared with the existing design scheme of crushing the ampoule tube to make the medical adhesive therein flow out, the utility model has obvious actual effective usage. The medical adhesive sold on the market generally has a specification of about 0.5ml, and the product itself has a relatively small amount, so the amount of adhesive adsorbed by the ampoule tube fragments has a great influence on the actual usage. Through test evaluation, the actual amount of the product with a specification of 0.5ml is about 0.8ml, and the product amount is 60% higher, which has a great influence on the efficiency and cost of actual production. Therefore, the ampoule bottle packaging form of the medical adhesive applicator of the utility model has a significant improvement in economic benefits. Through actual testing, the actual usage of the adhesive is increased by about 40% by using the ampoule tube packaging type medical applicator designed in this case compared with the ampoule tube packaging type applicator of the same specification. For example, the actual usage of the ampoule tube packaging type applicator with a filling volume of 0.5ml is 0.25~0.3ml, while the actual usage of the ampoule bottle packaging type applicator with a filling volume of 0.5ml is 0.4~0.45ml.

[0015] The ampoule bottle used in the utility model medical adhesive applicator is a national standard product with a large market supply. The ampoule bottle production process and automatic packaging equipment are mature. Compared with ampoule tubes, it has significant advantages in product quality stability and packaging efficiency. There are two ways to force the ampoule tube to rupture by extrusion force: one is to design a torque amplification structure. At present, there are many related patents related to ampoule tube rupture drug delivery tools. Generally, it is achieved by designing related structural designs. The overall structure is relatively complex and increases product costs; the other is to use thin-walled ampoule tubes to reduce the rupture strength. The wall thickness of thin-walled ampoule tubes is generally around 0.2mm. At present, there is no mature process in China, and procurement and quality control are very difficult. In actual production, unqualified product sealing and cracks in ampoule tubes often occur, which have a great impact on the quality and cost of the products produced.

[0016] Based on the description of the above utility model, the medical adhesive applicator of the utility model adopts an ampoule bottle packaging form and achieves a good balance in operation, economy, safety and other aspects through an integrated design. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The utility model is further described below in conjunction with the accompanying drawings and embodiments.

[0018] Figure 1 , are three views of the medical adhesive applicator of the utility model, wherein A is the front view, B is the top view, and C is the left view;

[0019] Figure 2 , is an exploded view of the components of the medical adhesive applicator of the utility model;

[0020] Figure 3 , is an assembly cross-sectional view of the medical adhesive applicator of the utility model;

[0021] Figure 4 , is a component cross-sectional view of the medical adhesive applicator of the utility model;

[0022] Figure 5 , is a diagram illustrating the assembly of components of the medical adhesive applicator of the utility model;

[0023] Figure 6 , is a cross-sectional view of the assembly portion of the ampoule bottle and the applicator bottle of the medical adhesive applicator of the utility model;

[0024] Figure 7 , is a cross-sectional view of the assembly parts of the bottle stopper, the application head and the sealing head of the medical adhesive applicator of the utility model;

[0025] Figure 8 , is a cross-sectional view of the adhesive outlet portion of the application head of the medical adhesive applicator of the utility model;

[0026] Fig. 9 , is the appearance diagram of the medical adhesive applicator head of the utility model.

[0027] Reference numerals

[0028] like Figure 2 :Mark 1 is the ampoule bottle; mark 2 is the applicator bottle; mark 3 is the filter element; mark 4 is the bottle stopper; mark 5 is the applicator head; mark 6 is the sealing head.

[0029] like Figure 5 : Mark 1-1 is the far end of the ampoule bottle, and 1-2 is the near end of the ampoule bottle; mark 2-1 is the far end of the smear bottle, and 2-2 is the near end of the smear bottle; mark 4-1 is the far end of the stopper, and mark 4-2 is the near end of the stopper; mark 5-1 is the far end of the smear head, and mark 5-2 is the near end of the smear head;

[0030] like Figure 6 : Mark 2-1-1 is the gradient assembly position at the far end of the smear bottle

[0031] like Figure 7 :Mark 6-1 is the sealing structure of the sealing head

[0032] like Figure 8 : Mark 5-3 is the adhesive outlet of the applicator head

[0033] like Fig. 9 :Mark 5-4 is the coating surface of the coating head DETAILED DESCRIPTION

[0034] In order to more clearly and completely explain the content of the utility model, the concept of the utility model is explained below in combination with specific implementation methods. Of course, the provided embodiments are intended to illustrate the concept of the utility model, not all of the design solutions of the utility model, and should not be regarded as limitations of the design content of the utility model. Under the inspiration of the provided content, any solution made belongs to the protection scope of the utility model. Example

[0035] Combination Figure 2 , Figure 3 In this embodiment, the medical adhesive applicator is composed of an ampoule bottle 1, an applicator bottle 2, a filter element 3, a bottle stopper 4, an applicator head 5, and a sealing head 6. Before use, the well-packaged ampoule bottle is broken from the bottleneck to present the shape of the ampoule bottle 1, and then the proximal end 1-2 of the ampoule bottle is assembled to the gradient assembly position 2-1-1 at the distal end of the applicator bottle, and the preoperative preparation of the medical adhesive applicator is completed. When in use, the applicator head of the medical adhesive applicator is placed downward, and the proximal end 2-2 of the applicator bottle is pressed by fingers to observe the transfer of the adhesive in the ampoule bottle 1 until the adhesive is completely transferred to the proximal end 2-2 of the applicator bottle and stop pressing. The sealing head 6 is manually removed from the applicator head 5, and the applicator head 5 is placed above the wound site, and the proximal end 2-2 of the applicator bottle is squeezed to squeeze the adhesive out through the adhesive outlet part 5-3 of the applicator head to reach the wound site, and then the adhesive on the wound site is evenly applied through the applicator surface 5-4 of the applicator head.

[0036] The basic principle, main features and advantages of the present invention are shown and described above. In the process of applying with the medical adhesive applicator of the present invention, the convenience, safety and effectiveness of the product are fully demonstrated.

Claims

1. A medical adhesive applicator, characterized in that: include: Sealing head, applicator head, bottle stopper, filter element, ampoule bottle, applicator bottle; the applicator bottle is a hollow cylinder with through holes at both ends, the distal end of the cylinder is connected to the ampoule bottle, and the proximal end of the cylinder is connected to the bottle stopper; the bottle stopper is a hollow cylinder with through holes at both ends, the distal end is connected to the proximal end of the applicator bottle, and the proximal end is connected to the distal end of the applicator head; the applicator head is a hollow cylinder with through holes at both ends, and the proximal end is connected to the sealing head; the sealing head blocks the through hole at the proximal end of the applicator head.

2. The medical adhesive applicator as claimed in claim 1, wherein the distal assembly position of the applicator bottle is of variable diameter design, and the material of the applicator bottle is low-density polyethylene (LDPE).

3. The medical adhesive applicator as described in claim 1, wherein the filter element is placed below the proximal end of the ampoule bottle, the filter element is assembled in the bottle stopper or in the applicator bottle, the filter element is made of high-density polyethylene (HDPE), and filters solid impurities in the adhesive. Its appearance and the applicator bottle or the bottle stopper are interference fit to achieve sufficient filtration of solid impurities in the adhesive.

4. The medical adhesive applicator as claimed in claim 1, wherein the structure of the application head is designed so that the adhesive outlet portion is separated from the application surface of the application head and are not on the same plane, and the two are spatially separated by designing the application surface as a plurality of columnar structures.

5. The medical adhesive applicator as described in claim 1, wherein the sealing head is used to seal the proximal end of the applicator head, and its sealing structure is adapted to the shape of the adhesive outlet portion of the applicator head, and the sealing function is achieved by an interference fit with the adhesive outlet portion of the applicator head.

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