A multilayer capsule and a method for its preparation

Abstract

A kind of multilayer capsule and its preparation method, preparation method uses the following steps: (1) preparation first layer capsule;(2) fold, shrink the first layer capsule;(3) the second layer capsule is wrapped and arranged on the outer surface of the first layer capsule;(4) the first layer capsule is inflated;(5) stretch the capsule to form diameter section and variable diameter section;(6) rotate the capsule in the opposite direction;(7) fold, shrink the capsule;(8) heating, form multilayer capsule.A kind of multilayer capsule includes capsule, and the capsule is at least two layers structure, the both ends and middle section of the capsule are diameter section, the both ends and middle section of the capsule are variable diameter section, and the two layers of capsule are tightly combined.The multilayer capsule provided by the present application is a super high pressure resistant balloon that can withstand 40 atm, reduces the risk of balloon rupture when expanded under super high pressure greater than 30 atm, fully meets the needs of the field of vascular and orthopedics for balloon high pressure resistance, can rely on its own super high pressure resistance to open certain specific complex lesions, and is used for rescuing patients by clinicians without other auxiliary means.

Description

TECHNICAL FIELD

[0001] The present application relates to a kind of ultra-high pressure balloon, especially to a kind of multilayer balloon and its preparation method, belong to medical instrument field. BACKGROUND

[0002] Balloon is an important medical instrument for minimally invasive interventional treatment of cardiovascular diseases. The performance of balloon directly determines the success rate, efficacy and prognosis of minimally invasive interventional treatment. The pressure resistance of balloon is one of the main performances. The balloon with poor pressure resistance may rupture during intravascular balloon dilation, damaging the blood vessels of the patient. For some serious calcification, heavy plaque load or long-term chronic occlusion lesions, a balloon that can withstand 30 atm, even 40 atm or higher pressure is often needed to dilate and open the lesions. Under the pressure of 30 atm, even 40 atm, if the balloon cannot withstand the pressure and ruptures, it will cause serious damage to the patient's blood vessels, which may cause blood vessel dissection or tearing, or even blood vessel perforation or rupture, endangering the patient's life. Currently, the rated burst pressure of balloons used in cerebral vessels, coronary arteries, peripheral vessels and orthopedic fields is generally 14-20 atm, and the highest is not more than 30 atm. This cannot fully meet the clinical application. The existing balloon usually selects single-material single-layer extruded pipe, multi-material single-layer extruded pipe, multi-material double-layer co-extruded pipe and other different pipes, and adjusts the balloon forming process parameters to obtain higher pressure resistance. However, it can only achieve a small improvement in pressure resistance, and cannot achieve a breakthrough. Due to the insufficient pressure resistance of the existing high-pressure balloon, doctors cannot use the existing balloon to open the lesions when encountering some specific complex lesions, and can only use auxiliary means such as rotary grinding plaque or laser ablation to process the lesions before using the existing balloon for dilation. The auxiliary means such as rotary grinding plaque or laser ablation causes great damage to the blood vessels. Therefore, doctors in clinical practice need an ultra-high pressure balloon that can withstand 30 atm or more, even 40 atm, to treat some specific complex lesions and save patients. SUMMARY

[0003] To solve the above problems, the present application changes the common way of selecting single-material single-layer extruded pipe, multi-material single-layer extruded pipe, multi-material double-layer co-extruded pipe and other different pipes, and adjusting the balloon forming process parameters to obtain higher pressure resistance, overcomes the shortcomings of the existing balloon pressure resistance, and provides a kind of multilayer balloon, the technical scheme is as follows:

[0004] A kind of multilayer balloon, comprising a balloon body, the balloon body is at least two layers of structure, the balloon body two ends and middle section are diameter section, the balloon body two ends and middle section are variable diameter section, two layers of balloon body are tightly combined.

[0005] The material of the capsule is one or more of polyvinyl chloride, polyamide, polyurethane, polyether block polyamide, polyethylene terephthalate, polyethylene, polypropylene, polymethyl methacrylate, polytetrafluoroethylene, expanded polytetrafluoroethylene, silica gel, rubber, and latex.

[0006] The first layer of the capsule is blow molded.

[0007] The second layer of the capsule is braided.

[0008] A method for preparing a multi-layer capsule, comprising the following steps:

[0009] (1) preparing a first layer of the capsule;

[0010] (2) folding and shrinking the first layer of the capsule;

[0011] (3) wrapping a second layer of the capsule around the outer surface of the first layer of the capsule;

[0012] (4) inflating the first layer of the capsule;

[0013] (5) stretching the capsule to form a diameter section and a variable diameter section;

[0014] (6) rotating the capsule in the opposite direction;

[0015] (7) folding and shrinking the capsule;

[0016] (8) heating to form a multi-layer capsule.

[0017] Steps (5) and (6) can be swapped.

[0018] Steps (5) and (6) can be performed simultaneously.

[0019] The folding and shrinking effect of the first layer of the capsule in step (2) affects the diameter selection of the second layer of the capsule, thereby affecting the tightness of the combination. Poor combination can result in a lower than expected burst pressure.

[0020] The first layer of the capsule in step (2) is coated with an adhesive.

[0021] In step (5), the capsule includes the first layer of the capsule and the second layer of the capsule, and the diameter sections at both ends of the first layer of the capsule and the second layer of the capsule are combined by welding, which improves the burst pressure performance at both ends of the capsule.

[0022] The stretching effect of the capsule in step (5) affects the tightness of the combination between the capsules. Poor combination can result in a lower than expected burst pressure.

[0023] In step (6), the capsule is rotated in the opposite direction, so that the inner surface of the inner layer of the capsule, the adhesive, and the inner surface of the outer layer of the capsule are uniformly contacted, achieving better tightness of the combination. Poor combination can result in a lower than expected burst pressure.

[0024] The first layer of the capsule and the second layer of the capsule need to be heated in step (6), which is to soften and shape the capsule and strengthen the close combination of the two layers of the capsule.

[0025] In step (7), the multi-layer capsule is folded and tightened, which affects the close combination degree. If the combination is not good, the burst pressure will not reach the expected value.

[0026] Compared with the prior art, the multi-layer capsule provided by the application is an ultra-high pressure resistant balloon that can withstand 40 atm, reduces the risk of balloon rupture when expanded under an ultra-high pressure greater than 30 atm, fully meets the needs of the field of blood vessels and orthopedics for balloon high pressure resistance, and can open certain specific complex lesions relying on its ultra-high pressure resistance, for clinicians to treat patients without other auxiliary means. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 is a cross-sectional structure diagram of the multi-layer capsule of the application;

[0028] In the figure: 1, second layer of capsule, 2, first layer of capsule, 3, first diameter section, 4, second diameter section, 5, variable diameter section. DETAILED DESCRIPTION

[0029] The application will be further described in detail below in combination with the drawings and specific examples.

[0030] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiment or the prior art description. Obviously, the drawings described below are only some embodiments of the application. Those skilled in the art can obtain other drawings according to these drawings without creative labor.

[0031] Example 1

[0032] A method for preparing a multi-layer capsule, the steps are as follows:

[0033] (1) preparing a first layer of capsule;

[0034] (2) folding and tightening the first layer of capsule;

[0035] (3) wrapping the second layer of capsule on the outer surface of the first layer of capsule;

[0036] (4) inflating the first layer of capsule;

[0037] (5) stretching the second layer of capsule to form a first diameter section, two second diameter sections and two variable diameter sections;

[0038] (6) Reverse rotation of the first layer of capsules and the second layer of capsules;

[0039] (7) Folding and shrinking of the first layer of capsules and the second layer of capsules;

[0040] (8) Heating to form a double layer of capsules.

[0041] Example 2

[0042] A method for preparing a multi-layer capsule, the steps of which are as follows:

[0043] (1) Preparation of the first layer of capsules;

[0044] (2) Folding and shrinking of the first layer of capsules;

[0045] (3) The second layer of capsules is wrapped around the outer surface of the first layer of capsules;

[0046] (4) Inflating the first layer of capsules;

[0047] (5) Stretching the second layer of capsules to form a first diameter section, two second diameter sections and two variable diameter sections;

[0048] (6) Reverse rotation of the first layer of capsules and the second layer of capsules;

[0049] (7) Heating of the first layer of capsules and the second layer of capsules;

[0050] (8) Folding and shrinking of the first layer of capsules and the second layer of capsules;

[0051] (9) Heating to form a double layer of capsules.

[0052] Example 3

[0053] A method for preparing a multi-layer capsule, the steps of which are as follows:

[0054] (1) Preparation of the first layer of capsules;

[0055] (2) Folding and shrinking of the first layer of capsules;

[0056] (3) Adding an adhesive to the first layer of capsules;

[0057] (4) The second layer of capsules is wrapped around the outer surface of the first layer of capsules;

[0058] (5) Inflating the first layer of capsules;

[0059] (6) While reverse rotating the first layer of capsules and the second layer of capsules, stretching the second layer of capsules to form a first diameter section, two second diameter sections and two variable diameter sections;

[0060] (7) Folding and shrinking of the first layer of capsules and the second layer of capsules;

[0061] (8) Repeat steps (3)-(7);

[0062] (9) Heating forms a three-layered capsule.

[0063] Example 4

[0064] A method for preparing a multilayer capsule, comprising the following steps:

[0065] (1) Preparation of the first vesicle layer;

[0066] (2) Fold and tighten the first layer of the capsule;

[0067] (3) The second layer of capsule is wrapped around the outer surface of the first layer of capsule;

[0068] (4) The first layer of the cyst bulges out;

[0069] (5) Stretch the second layer of the capsule to form a first diameter segment, two second diameter segments and two variable diameter segments;

[0070] (6) Rotate the first and second cysts in opposite directions;

[0071] (7) Weld the second diameter segment of the second layer capsule to the second diameter segment of the first layer capsule;

[0072] (8) Fold and tighten the first and second cyst layers;

[0073] (9) Repeat steps (3)-(7) twice;

[0074] (10) Heating forms a four-layered capsule.

[0075] Example 5

[0076] like Figure 1 As shown, a multilayer capsule was prepared according to the preparation method of Example 1. The capsule has a two-layer structure, with the two ends and the middle section being diameter sections, and the section between the two ends and the middle section being a variable diameter section. The two layers of the capsule are tightly bonded together.

[0077] Example 6

[0078] like Figure 1 As shown, following the preparation method in Example 1, the first layer of the capsule was formed by blow molding of polyamide tubing, and the burst pressure of three samples was tested, as shown in Table 1.

[0079] Example 7

[0080] like Figure 1 As shown, following the preparation method in Example 3, a first layer of capsule was formed by blow molding of polyamide tubing, and a second layer of capsule was formed by weaving polyethylene phthalate. The second layer of capsule and the first layer of capsule were bonded together to form a double-layer capsule. The burst pressure of three samples was tested, as shown in Table 1.

[0081] Example 8

[0082] like Figure 1 As shown, following the preparation method in Example 4, the first layer of the capsule was formed by blow molding of polyether block polyamide tubing, and the burst pressure of three samples was tested, as shown in Table 1.

[0083] Example 9

[0084] like Figure 1 As shown, following the preparation method in Example 2, the first layer of the capsule was formed by blow molding of polyether block polyamide tubing, and the second layer of the capsule was formed by polyethylene braiding. The second layer of the capsule and the first layer of the capsule were then heat-pressed to form a double-layer capsule. The burst pressure of the three samples was tested, as shown in the table below.

[0085]

[0086] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A method of making a multi-layered capsule, characterized by The following steps: (1) preparing the first layer of capsule; (2) folding and shrinking the first layer of capsule; (3) wrapping the second layer of capsule on the outer surface of the first layer of capsule; (4) bulging the first layer of capsule; (5) stretching the capsule to form a diameter section and a variable diameter section; (6) rotating the capsule in the opposite direction; (7) folding and shrinking the capsule; (8) heating to form a multi-layer capsule; The first layer of capsule and the second layer of capsule in step (6) need to be heated.

2. A method of making a multi-layered capsule according to claim 1, characterized in that The order of step (5) and step (6) is changed.

3. The method of claim 1, wherein Step (5) and step (6) are performed simultaneously.

4. The method of claim 1, wherein The surface of the first layer of capsule in step (2) is coated with an adhesive.

5. The method of claim 1, wherein The capsule in step (5) includes the first layer of capsule and the second layer of capsule, and the diameter sections at both ends of the first layer of capsule and the second layer of capsule are combined by welding.

Images