CN210582768U

CN210582768U - Double-level compliance medical balloon

Info

Publication number: CN210582768U
Application number: CN201920057892.7U
Authority: CN
Inventors: 邱钢; 孔维维
Original assignee: Curatia Medical Ltd
Current assignee: Curatia Medical Ltd
Priority date: 2019-01-14
Filing date: 2019-01-14
Publication date: 2020-05-22
Anticipated expiration: 2029-01-14

Abstract

The utility model discloses a double-water smooth-response medical balloon, the diameter of the balloon changes rapidly under the first level (within the low-pressure range), the diameter of the balloon can be accurately regulated and controlled by controlling the pressure, namely, the balloon has 6-11% of expansion rate in the diameter direction, preferably 8-10% in the expansion pressure range from the nominal pressure to the nominal pressure plus about 6 atm; at a second level (within the high pressure range), the balloon diameter changes less, and can concentrate pressure to fully expand lesions (especially heavily calcified lesions) or fully expand and adhere the stent, while reducing damage to the inner surface of the vessel, i.e., having an expansion rate in the diameter direction of 4-8%, preferably 4-6%, within the expansion pressure range of nominal pressure + about 6atm to nominal pressure + about 14 atm. The balloon can be used for pre-expansion and post-expansion.

Description

Double-level compliance medical balloon

Technical Field

The utility model relates to a medical sacculus especially relates to a smooth-going medical sacculus of nature of two water.

Background

The medical saccule is applied to interventional therapy of cardiovascular, peripheral blood vessels and cerebrovascular, and the saccule for clinical application is divided into pre-expansion and post-expansion aiming at different applications, wherein the former aims at expanding a blood vessel at a lesion section, and is beneficial to smooth passing of a stent system and the like, or a stent pressed on the saccule is opened in the blood vessel by utilizing the expansion effect of the saccule; the latter aims to expand the stent so that it better adheres to the inner wall of the vessel.

Currently, pre-dilation balloons are generally semi-compliant balloons (patent publication No.: US 20100318029 a1), which have the following advantages: the material is soft, the adaptability to the shape of the blood vessel is good, and the diameter of the saccule can be accurately regulated and controlled by controlling the pressure; the disadvantages are as follows: under high pressure (generally equal to or more than 14atm), the 'dog bone' is easy to generate (expansion pressure is concentrated to a region with smaller resistance, so that the saccule is expanded outside a lesion or a stent), the extrusion force to the lesion is not enough to expand a hard lesion or the stent is not completely expanded or attached to the wall, and the saccule parts protruding from two ends of the lesion or the stent can damage normal vascular wall tissues at two ends of the lesion, cause edge effect to cause restenosis or interlayer at the lesion at two ends of the stent, and can also cause rupture and perforation of blood vessels or serious interlayer events.

The post-dilation balloon is generally a non-compliant balloon (high pressure balloon) (patent publication No. US 8535596B 2), which has the advantages: the balloon OD is limited along with the increase of the filling pressure, so that the full expansion of stenotic lesions or the complete adherence of the stent is ensured, the blood vessel is not excessively expanded, the incidence rate of blood vessel interlayers is reduced, and in addition, the balloon OD is also applied to difficultly expanded lesions such as bifurcation lesions, open lesions, stent overlapping parts, stent restenosis and the like due to strong expansion force; the disadvantages are as follows: the material is hard and has poor adaptability to the shape of blood vessels.

SUMMERY OF THE UTILITY MODEL

The utility model aims at providing a medical sacculus of smooth-going response of two water.

The utility model aims at realizing through the following technical scheme:

the utility model discloses a double water smooth-response medical sacculus, the diameter ratio of this sacculus under first level is its diameter under nominal pressure increase 6 ~ 11%, the first level refers to the inflation pressure range of above nominal pressure to nominal pressure +6 atm;

the balloon increases in diameter by 4-8% at a second level, which refers to an inflation pressure range from nominal pressure +6atm to nominal pressure +14atm, from its diameter at the first level.

According to the technical scheme provided by the utility model, the diameter of the double-level compliance medical saccule provided by the embodiment of the utility model is changed rapidly under the first level (in the low pressure range), and the diameter of the saccule can be accurately regulated and controlled by controlling the pressure; at a second level (in the high pressure range) the balloon diameter changes less, concentrating the pressure to fully dilate the lesion (especially a heavily calcified lesion) or to allow the stent to fully expand and adhere to the wall, while reducing damage to the inner surface of the vessel. Therefore, the balloon of the utility model can be used for pre-expansion and post-expansion.

Drawings

Fig. 1 is a compliance illustration of a balloon of an embodiment of the present invention.

Fig. 2 is a compliance illustration of an existing semi-compliant balloon.

Fig. 3 is a compliance illustration of an existing non-compliant balloon.

Detailed Description

Embodiments of the present invention will be described in further detail below. Details not described in the embodiments of the present invention belong to the prior art known to those skilled in the art.

The utility model discloses a smooth-going medical sacculus of nature of two water, the concrete implementation mode of its preferred is:

the diameter of the balloon at a first level is increased by 6-11% compared with the diameter of the balloon at a nominal pressure, and the first level refers to an expansion pressure range from the nominal pressure to the nominal pressure plus 6 atm;

Preferably:

the diameter of the balloon at a first level is increased by 8-10% from its diameter at nominal pressure;

the diameter of the balloon at the second level is increased by 4-6% of its diameter at the first level.

The balloon is a single-layer balloon made of a single-layer material or a composite balloon made of a multi-layer material, or a single-layer balloon or a composite balloon made of a composite balloon and a metal material.

The cross section of the balloon is circular, elliptical or irregular.

The balloon material is one or more of nylon 12, Pebax 25D, Pebax 35D, Pebax 55D, Pebax 63D, Pebax70D, Pebax 72D, TPU, PET, PE and metal.

The double-water smooth-response medical balloon has the advantages that the diameter of the balloon changes rapidly at a first level (within a low-pressure range), and the diameter of the balloon can be accurately regulated and controlled by controlling pressure; at a second level (in the high pressure range) the balloon diameter changes less, concentrating the pressure to fully dilate the lesion (especially a heavily calcified lesion) or to allow the stent to fully expand and adhere to the wall, while reducing damage to the inner surface of the vessel. Therefore, the balloon of the utility model can be used for pre-expansion and post-expansion.

The specific embodiment is as follows:

as shown in FIG. 1 (compare FIGS. 2 and 3), the balloon of the present invention has a bi-level compliance, i.e., a 6-11% diametrical expansion ratio at a first level (within the range of expansion pressures from above Nominal Pressure (NP) to Nominal Pressure (NP) + about 6 atm), and more preferably, a 8-10% diametrical expansion ratio at this level. The expansion rate at this time was calculated by [ (nominal pressure + balloon diameter at about 6 atm) -balloon diameter at nominal pressure ]/balloon diameter at nominal pressure 100%; the balloon has a diametric expansion ratio of 4 to 8% at a second level (within an expansion pressure range of a Nominal Pressure (NP) + about 6atm to a Nominal Pressure (NP) + about 14atm), and preferably, 4 to 6% at this level, where the expansion ratio is calculated by [ (balloon diameter at nominal pressure + about 14atm) - (balloon diameter at nominal pressure + about 6 atm) ]/(balloon diameter at nominal pressure + about 6 atm) × 100%.

In this specification, "Nominal Pressure (NP)" refers to the pressure required to inflate a balloon to a given diameter; "balloon diameter" refers to the average outer diameter of the portion of the balloon that is effective for dilation.

The utility model discloses a still can add the X ray opaque material in each layer material of sacculus.

The utility model has the advantages that:

the saccule of the utility model has double-level compliance, the diameter of the saccule changes rapidly under the first level (in a low pressure range), and the diameter of the saccule can be accurately regulated and controlled by controlling the pressure; at a second level (in the high pressure range) the balloon diameter changes less, concentrating the pressure to fully dilate the lesion (especially a heavily calcified lesion) or to allow the stent to fully expand and adhere to the wall, while reducing damage to the inner surface of the vessel. Therefore, the balloon of the utility model can be used for pre-expansion and post-expansion.

The balloon of the specific embodiment is realized by the following technical scheme:

the method comprises the following steps:

1) the single material or the multiple materials are directly extruded or blended and extruded to form a single-layer pipe with certain size, or the single material or the multiple materials are formed into a multi-layer extruded pipe with certain size by using a co-extrusion technology (the inner layer material of the multi-layer pipe is relatively soft and is generally elastic, or is a composite material of the elastic and inelastic, and the outer layer material is relatively hard. To improve the boundary adhesion between the inner and outer layer materials, it is conceivable to add tie layers as intermediate layers, which may be elastomer-containing or elastomer-free materials or composites).

2) The tube is axially stretched into a neck at a temperature to form a parison. Specifically, the tube should be biaxially stretched in the range from the glass transition temperature to the melting temperature of each material, and the stretching ratio should not exceed the maximum stretching ratio of the material itself. Cooling the formed blank to below the glass transition temperature of each material of the pipe.

3) The material is soaked in a balloon mould and is subjected to blow molding under certain pressure, temperature and stretching rate. Specifically, the cooled parison is subjected to biaxial stretching while being pressurized in a range from the glass transition temperature to the melting temperature of each material, and is expanded in the radial direction and extended in the longitudinal direction to be bonded to the balloon mold. The stretching ratio should not exceed the maximum stretching ratio of the material.

4) Maintaining a certain pressure and temperature, and redrawing the taper of the balloon which is subjected to bidirectional axial stretching according to needs, so that the wall thickness of the taper part is reduced, and the shape of the balloon is kept. Specifically, the pressure selected should be above the intended burst pressure of the balloon and the temperature selected should be within the range of the glass transition temperature to the melting temperature of the materials of the tubing.

5) The balloon was cooled to below the glass transition temperature of each material, and the balloon was taken out.

The second method comprises the following steps:

1) the steps in reference method one form a single layer or composite balloon.

2) And covering a layer of metal braided fabric on the outer surface of the formed balloon, and combining the two layers of metal braided fabric to form the combined balloon. The braid has a certain deformation space, and at a first level (in a low pressure range), the braid deforms simultaneously with the compression expansion of the balloon; at a second level (in the high pressure range), the deformation of the braid is close to its limit, thus acting to limit the change in balloon diameter.

The above description is only for the preferred embodiment of the present invention, but the protection scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are all covered by the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. The utility model provides a smooth-going medical sacculus of nature of two water which characterized in that:

the diameter of the balloon at the first level is 106-111% of the diameter of the balloon at the nominal pressure;

the diameter of the balloon at the second level is 104-108% of the diameter of the balloon at the first level.

2. The dual smooth compliance medical balloon of claim 1, wherein:

the diameter of the balloon at the first level is 108-110% of the diameter of the balloon at the nominal pressure;

the diameter of the balloon at the second level is 104-106% of the diameter of the balloon at the first level.

3. The dual smooth-response medical balloon according to claim 1 or 2, wherein the balloon is a single-layer balloon composed of a single-layer material or a composite balloon composed of a multi-layer material, or a single-layer balloon or a composite balloon formed by a composite balloon and a metal material.

4. The dual smooth compliance medical balloon of claim 3, wherein the cross-sectional shape of the balloon is circular, elliptical, or irregular.

5. The bi-smooth compliant medical balloon of claim 4, wherein the balloon material is one or more of nylon 12, Pebax 25D, Pebax 35D, Pebax 55D, Pebax 63D, Pebax70D, Pebax 72D, TPU, PET, PE, metal.