Bi-level compliant medical balloon

Abstract

The invention discloses a bi-level compliant medical balloon. At the first level (in a low pressure range), the diameter of the balloon changes rapidly, and the diameter of the balloon can be precisely controlled by controlling the pressure, namely, in the expansion pressure range from the nominal pressure to the nominal pressure + of about 6 atm, and the balloon has the expansion rate of 6-11%, preferably 8-10% in the diameter direction; and at the second level (in a high pressure range), the diameter of the balloon is small, the pressure can be centralized to fully expand a lesion (especially a severely calcified lesion) or allow a stent to fully expand and adhere to the wall, meanwhile the damages to the inner surfaces of blood vessels are decreased, namely, in the expansion pressure range from the nominal pressure + of about 6 atm to the nominal pressure + of about 14 atm, and the balloon has the expansion rate of 4-8%, preferably 4-6% in the diameter direction. The balloon can beused for both pre-expansion and post-expansion.

Description

technical field [0001] The invention relates to a medical balloon, in particular to a bi-level compliance medical balloon. Background technique [0002] Medical balloons are used in the interventional treatment of cardiovascular, peripheral blood vessels and cerebrovascular. According to different applications, clinical balloons are divided into two types: pre-expansion and post-expansion. Wait for the smooth passage, or use the expansion effect of the balloon to open the stent pressed on the balloon in the blood vessel; the purpose of the latter is to expand the stent so that it can better adhere to the inner wall of the blood vessel. [0003] At present, pre-dilation balloons are generally semi-compliant balloons (patent publication number: US 20100318029 A1). Its advantages: soft material, good adaptability to the shape of blood vessels, and the diameter of the balloon can be precisely adjusted by controlling the pressure; disadvantages: (generally ≥14 atm) is prone to "...

AI Technical Summary

Problems solved by technology

[0003] At present, pre-dilation balloons are generally semi-compliant balloons (patent publication number: US 20100318029 A1). Its advantages: soft material, good adaptability to the shape of blood vessels, and the diameter of the balloon can be precisely adjusted by controlling the pressure; disadvantages: (generally ≥14 atm) is prone to "dog bone" (expansion pressure concentrates on the area with less resistance, causing the balloon to bulge outside the lesion or outside the stent), resulting in insufficient squeezing force on the lesion to expand the hard lesion or The stent is not fully expanded or attached to the wall, and the lesion or the protruding balloon parts at both ends of the stent may damage the normal blood vessel wall tissue at both ends of the lesion, resulting in edge effects that cause restenosis at both ends of the stent or dissection at the lesion, and may also cause vessel rupture and perforation or serious dissection event

[0004] Post-dilatation balloons are generally non-compliant balloons (high pressure balloons) (patent publication number: US8535596 B2), which have the advantages of high filling pressure, with limited changes in balloon OD as the filling pressure increases, ensuring sufficient stenotic lesions. When the expansion or stent is completely attached to the wall, it will not over-expand the blood vessel and reduce the incidence of vascular dissection. In addition, due to its strong expansion force, it is also suitable for bifurcation lesions, open lesions, overlapping stents, and in-stent restenosis, which are not easy to expand. Disadvantages: hard material, poor adaptability to blood vessel shape

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