Drug balloon far-end protective sleeve assembly

Abstract

The utility model discloses a medicine balloon far-end protective sleeve assembly, and belongs to the field of medical instruments. Comprising an inner protective sleeve and an outer protective sleeve, an installation cavity used for installing the far end of a medicine balloon is formed in the inner protective sleeve, an easy-to-tear part is arranged on the inner protective sleeve, and the inner protective sleeve is sleeved with the outer protective sleeve. According to the utility model, the inner protective sleeve and the outer protective sleeve are arranged, the inner protective sleeve is used for sleeving the drug balloon, and the far end of the drug balloon is positioned in the mounting cavity, so that a first protection effect is achieved; the inner protective sleeve is sleeved with the outer protective sleeve, so that the inner protective sleeve is in close fit with the folded medicine balloon, the effects of limiting and resisting deformation of the folded medicine balloon are achieved, the second protection effect is achieved, and the protection effect can be improved through double protection; medicine loss caused by tight fit friction force when an operator takes down the protective sleeve can be reduced, and the shape of the folded medicine balloon can be kept.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, and specifically relates to a drug-protected balloon structure. Background Technology

[0002] Drug-eluting balloons are considered one of the representative treatment options for "interventional without implantation," and have become a fiercely contested area for medical device companies. A drug-eluting balloon is simply a carrier of drugs, a transport tool that delivers drugs to the lesion site. Upon arrival at its destination, the balloon inflates, allowing the drug to adhere tightly to the vascular endothelium. Once the drug has been released locally, the balloon is withdrawn from the body.

[0003] In specific treatment scenarios, the targeted drug is applied to the surface of a balloon via various methods, and then the balloon is delivered to the target blood vessel for release. However, besides the drug released at the target blood vessel and the drug lost during delivery, other factors can cause drug loss. Minimizing drug loss has always been a significant concern in the field. Less drug loss means more drug reaches the target blood vessel, resulting in greater absorption within the same timeframe. Furthermore, a low loss rate allows for a reduction in drug concentration, achieving the same therapeutic effect while improving surgical safety.

[0004] Currently, there are design solutions on the market to reduce drug loss. These involve attaching a protective sleeve to the folded drug-eluting balloon to prevent it from expanding and deforming. The protective sleeve fits snugly against the folded balloon, which can reduce drug loss to some extent. However, the protective sleeve needs to be removed before use. Because most protective sleeves on the market are not easy to tear, friction occurs between the protective sleeve and the drug on the balloon surface during removal. This can cause some of the drug on the balloon surface to be lost before it enters the body, thus affecting the treatment effect. Utility Model Content

[0005] To address the aforementioned problems, the primary objective of this invention is to provide a distal protective sleeve assembly for drug-eluting balloons, which reduces drug loss from the balloons, provides good protection, and is convenient to use.

[0006] Another objective of this invention is to provide a distal protective sleeve assembly for drug-eluting balloons, which is easy to install and disassemble, easy to manufacture and process, improves the uniformity of drug content, and increases production efficiency.

[0007] To achieve the above objectives, the technical solution of this utility model is as follows:

[0008] This utility model provides a distal protective sleeve assembly for a drug-eluting balloon, characterized in that it includes an inner protective sleeve and an outer protective sleeve. The inner protective sleeve has an installation cavity for installing the distal end of the drug-eluting balloon, and the inner protective sleeve has an easy-tear portion. The outer protective sleeve is fitted over the inner protective sleeve. The easy-tear portion is a structure that is easy to tear.

[0009] In this invention, an inner protective sleeve and an outer protective sleeve are used. The inner protective sleeve is fitted over the drug-eluting balloon, ensuring the distal end of the balloon is positioned within the installation cavity, thus providing the first layer of protection. The outer protective sleeve is fitted over the inner protective sleeve, which acts as a limiting element, providing the second layer of protection. This dual protection enhances the protective effect and reduces drug loss. Furthermore, the inner protective sleeve has an easy-tear section, allowing for convenient opening during use and improving ease of use.

[0010] Furthermore, the tear-resistant section has at least one notch, with the notch length approximately two-thirds the length of the inner protective sleeve. Since the inner protective sleeve's mounting cavity and the distal end of the drug-eluting balloon are tightly fitted, the notch design not only facilitates tearing the inner protective sleeve during use but also allows the inner protective sleeve to deform during the insertion or removal of the distal end of the drug-eluting balloon from the mounting cavity. This reduces friction between the inner protective sleeve and the drug-eluting balloon, thereby minimizing drug loss due to friction. The outer protective sleeve, fitted onto the inner protective sleeve, ensures a tight fit between the inner protective sleeve and the balloon, guaranteeing overall protection and containment, and resisting stress deformation of the drug-eluting balloon after folding.

[0011] Furthermore, there are two notches, symmetrically arranged on both sides of the inner protective sleeve. These two notches directly divide the inner protective sleeve into upper and lower parts, making it very convenient to tear open when needed and also facilitating the installation of the drug-eluting balloon.

[0012] Furthermore, the inner protective sleeve extends beyond the outer protective sleeve to form an extension. This extension can effectively withstand stress during production, processing, and use, significantly reducing the difficulty of attaching the outer protective sleeve to the inner protective sleeve, and also reducing the difficulty of removing the outer protective sleeve from the inner protective sleeve.

[0013] Furthermore, the extension is located at the tail end of the inner protective sleeve, and an auxiliary protective cavity is formed between the head end of the inner protective sleeve and the head end of the outer protective sleeve. The mounting cavity of the inner protective sleeve has a through-hole structure. The mounting cavity allows the distal head of the drug-eluting balloon to pass through. In normal conditions, after the distal end of the drug-eluting balloon is inserted into the inner protective sleeve, the head of the drug-eluting balloon will pass through the mounting cavity of the inner protective sleeve and enter the auxiliary protective cavity. The auxiliary protective cavity effectively protects the head of the drug-eluting balloon.

[0014] Furthermore, the inner protective sleeve has the same length as the outer protective sleeve. By setting the lengths of the inner and outer protective sleeves to be the same, an extension can be formed at one end while an auxiliary protective cavity is formed at the other end simultaneously, eliminating the need for additional redundant structures and simplifying manufacturing.

[0015] Furthermore, the outer surface of the outer protective sleeve is provided with several protrusions. The protrusions facilitate loading and unloading during automated processing, thereby improving production efficiency.

[0016] Furthermore, both the inner and outer protective sleeves are cylindrical, and each has a through-channel inside. The cylindrical structure effectively matches the shape of the drug delivery balloon and facilitates manufacturing.

[0017] Furthermore, the inner protective sleeve is made of commonly used medical materials such as PTFE, FEP, HDPE, silicone, nylon, and PEBAX.

[0018] Furthermore, the outer protective sleeve is made of commonly used medical materials such as PTFE, HDPE, silicone, nylon, PEBAX, PC, and FEP.

[0019] The advantages of this invention compared to existing technologies are as follows: By using an inner protective sleeve and an outer protective sleeve, the inner protective sleeve covers the drug-eluting balloon, ensuring the distal end of the balloon is positioned within the installation cavity, thus providing the first layer of protection. The outer protective sleeve covers the inner protective sleeve, which acts as a limiting element, providing the second layer of protection. This dual protection enhances the protective effect and reduces drug loss. Furthermore, the inner protective sleeve has an easy-tear section, allowing for convenient opening during use and improving ease of use. Attached Figure Description

[0020] Figure 1 This is a left view of the inner protective sleeve of this utility model.

[0021] Figure 2 This is the front view of the inner protective sleeve of this utility model.

[0022] Figure 3 This is a right view of the inner protective sleeve of this utility model.

[0023] Figure 4 This is a left view of the outer protective sleeve of this utility model.

[0024] Figure 5 This is the front view of the outer protective sleeve of this utility model.

[0025] Figure 6 This is a schematic diagram showing the usage status of the inner protective sleeve, outer protective sleeve, and distal end of the drug-eluting balloon assembly of this utility model.

[0026] Figure 7 This is a schematic diagram of the distal end of the balloon in three sections. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present utility model and are not intended to limit the present utility model.

[0028] See Figure 1-7 This embodiment provides a distal protective sleeve assembly for a drug-eluting balloon, including an inner protective sleeve 1 and an outer protective sleeve 2. The inner protective sleeve 1 has an installation cavity 11 for installing the distal end 3 of the drug-eluting balloon, and the inner protective sleeve 1 has an easy-tear portion 4. The outer protective sleeve 2 is fitted onto the inner protective sleeve 1. The easy-tear portion 4 is a structure that is easy to tear.

[0029] In this invention, an inner protective sleeve 1 and an outer protective sleeve 2 are provided. The inner protective sleeve 1 is used to cover the drug-eluting balloon, ensuring that the distal end 3 of the drug-eluting balloon is located within the installation cavity, thus providing the first layer of protection. The outer protective sleeve 2 is fitted over the inner protective sleeve 1, which acts as a limiting element, thus providing the second layer of protection. This dual protection enhances the protective effect and reduces drug loss. Furthermore, the inner protective sleeve 1 is provided with an easy-tear section 4, allowing for convenient tearing during use and improving ease of use.

[0030] In practice, the outer protective sleeve 2 is first removed. Since the outer protective sleeve 2 only contacts the inner protective sleeve 1, there will be friction between the two during the removal process, but it will not cause the drug to be lost. After the outer protective sleeve 2 is removed, the inner protective sleeve 1 is torn open by the easy-tear part 4 provided on the inner protective sleeve 1, so that the drug balloon installed in the inner protective sleeve 1 can work normally. It is not only convenient to use, but also can greatly reduce the loss of drugs.

[0031] In this embodiment, the tear-resistant portion 4 has at least one notch, and the length of the notch is approximately two-thirds of the length of the inner protective sleeve. Since the mounting cavity 11 of the inner protective sleeve 1 and the distal end 3 of the drug balloon are tightly fitted, the notch design not only facilitates tearing the inner protective sleeve 1 during use, but also allows the inner protective sleeve 1 to deform during the insertion or removal of the distal end 3 of the drug balloon from the mounting cavity, reducing the friction between the inner protective sleeve 1 and the drug balloon, thereby reducing drug loss due to friction. The outer protective sleeve 2 is fitted onto the inner protective sleeve 1, working in conjunction with the inner protective sleeve 1 to ensure overall protection and restraint, resisting stress deformation of the drug balloon after folding. The notch length of approximately two-thirds of the inner protective sleeve length allows for both restraint and easy tearing.

[0032] In this embodiment, there are two notches, symmetrically arranged on both sides of the inner protective sleeve 1. This makes it very convenient to tear open when needed, and also convenient to install the drug-eluting balloon.

[0033] In this embodiment, the inner protective sleeve 1 extends beyond the outer protective sleeve 2 to form an extension 12. The extension 12 can withstand stress well during manufacturing and use, greatly reducing the difficulty of attaching the outer protective sleeve 2 to the inner protective sleeve 1 and also reducing the difficulty of removing the outer protective sleeve 2 from the inner protective sleeve 1. The extension 12 is a part of the inner protective sleeve 1 itself; however, because the inner protective sleeve 1 is not completely covered by the outer protective sleeve 2, a portion of the inner protective sleeve 1 protrudes beyond the outer protective sleeve 2, thus forming the aforementioned extension 12.

[0034] In this embodiment, the extension 12 is located at the tail end of the inner protective sleeve 1, and an auxiliary protective cavity 5 is formed between the head end of the inner protective sleeve 1 and the head end of the outer protective sleeve 2. The mounting cavity 11 of the inner protective sleeve 1 has a through-hole structure. The through-hole structure of the mounting cavity 11 allows the distal head 14 of the drug-eluting balloon to pass through. In normal conditions, after the distal end 3 of the drug-eluting balloon is inserted into the inner protective sleeve 1, the distal head 14 of the drug-eluting balloon will pass through the mounting cavity 11 and enter the auxiliary protective cavity 5. The auxiliary protective cavity 5 effectively protects the distal head 14 of the drug-eluting balloon.

[0035] In this embodiment, the inner protective sleeve 1 has the same length as the outer protective sleeve 2. By setting the lengths of the inner protective sleeve 1 and the outer protective sleeve 2 to be the same, an extension 12 can be formed at one end while an auxiliary protective cavity 5 is formed at the other end, eliminating the need for additional redundant structures and simplifying manufacturing.

[0036] In this embodiment, the outer surface of the outer protective sleeve 2 is provided with a plurality of protrusions 6. The protrusions 6 facilitate the gripping and loading / unloading during automated processing, thereby improving production efficiency. The protrusions are preferably strip-shaped protrusions.

[0037] In this embodiment, both the inner protective sleeve 1 and the outer protective sleeve 2 are cylindrical, with a permeable channel inside. The cylindrical structure can well match the shape of the drug capsule and is also convenient for manufacturing and processing.

[0038] In this embodiment, the inner protective sleeve 1 is made of commonly used medical materials such as PTFE, FEP, HDPE, silicone, nylon, and PEBAX.

[0039] In this embodiment, the outer protective sleeve 2 is made of commonly used medical materials such as PTFE, HDPE, silicone, nylon, PEBAX, PC, and FEP.

[0040] The preferred embodiments of this patent have been described in detail above. They are merely preferred embodiments of this utility model and are not intended to limit this utility model. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A drug balloon distal protection sheath assembly, comprising: The inner protective sleeve is provided with an installation cavity for installing the distal end of a drug balloon, and is provided with a tearable part.

2. The drug balloon distal protection sleeve assembly of claim 1, wherein, The tearable part is at least one notch.

3. The drug balloon distal protection sleeve assembly of claim 2, wherein, The notches are two and symmetrically arranged on both sides of the inner protective sleeve.

4. The drug balloon distal protection sleeve assembly of claim 1, wherein, The inner protective sleeve partially extends out of the outer protective sleeve to form an extension.

5. The drug balloon distal protection sleeve assembly of claim 4, wherein, The extension is located at the tail end of the inner protective sleeve, and an auxiliary protection cavity is formed between the head end of the inner protective sleeve and the head end of the outer protective sleeve.

6. The drug balloon distal protection sleeve assembly of claim 1, wherein, The length of the inner protective sleeve is the same as the length of the outer protective sleeve.

7. The drug balloon distal protection sleeve assembly of claim 1, wherein, The outer surface of the outer protective sleeve is provided with a plurality of protrusions.

8. The drug balloon distal protection sleeve assembly of claim 1, wherein, The inner protective sleeve and the outer protective sleeve are both cylindrical, and the interiors of the inner protective sleeve and the outer protective sleeve are both provided with a through channel.

9. The drug balloon distal protection sleeve assembly of claim 1, wherein, The material of the inner protective sleeve comprises one of PTFE, FEP, HDPE, silica gel, nylon and PEBAX.

10. The drug balloon distal protection sleeve assembly of claim 1, wherein, The material of the outer protective sleeve comprises one of PTFE, HDPE, silica gel, nylon, PEBAX, PC and FEP.

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